[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Vanderbilt-Ingram Cancer Center\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":616},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,28,0,25,[9,41,83,109,134,154,181,214,250,272,296,317,337,358,377,395,418,440,464,484,501,524,552,573,594],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100644823","phase-2-nemtabrutinib-with-car-t-therapy-in-relapsedrefractory-mantle-cell-lymphoma-100644823",false,"NCT07673367","Nemtabrutinib With CAR T Therapy in Relapsed\u002FRefractory Mantle Cell Lymphoma","A Phase 2 Trial of Nemtabrutinib in Combination With Brexu-cel for Patients With Relapsed\u002FRefractory Mantle Cell Lymphoma","Inclusion Criteria:\n\n* • Confirmed diagnosis of relapsed or refractory mantle cell lymphoma who meets institutional eligibility criteria to receive standard of care brexu-cel therapy\n\n  * Is an individual of any sex\u002Fgender, who are at least 18 years of age on the day of signing informed consent with confirmed diagnosis of R\u002FR MCL will be enrolled in this study\n  * The participant (or legally acceptable representative if applicable) has provided documented informed consent\u002Fassent for the trial\n  * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. Evaluation of ECOG is to be performed within 7 days prior to the first dose of study intervention\n  * The ability to swallow and retain oral medication\n\n    \\* NOTE: Administration of nemtabrutinib is not permitted through a percutaneous endoscopic gastro-jejunal (J-PEG) tube\n  * Participants who are hepatitis B virus surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to allocation\n\n    \\* Note: Participants should remain on anti-viral therapy throughout study intervention and follow local guidelines for HBV anti-viral therapy post completion of study intervention. Hepatitis B screening tests should include HBsAg and anti-HBV. Hepatitis B screening tests are not required unless:\n    * Known history of HBV infection\n    * As mandated by local health authority\n  * Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening\n\n    * Participants must have completed curative anti-viral therapy at least 4 weeks prior to allocation\n    * Hepatitis C screening tests are not required unless:\n\n      * Known history of HCV infection\n      * As mandated by local health authority\n  * Participants with HIV are eligible if they meet ALL of the following criteria:\n\n    \\* The CD4 count is ≥ 350 cells\u002FuL at screening\n    * The HIV viral load is below the detectable level as per locally available testing\n    * Are on a stable anti-retroviral therapy (ART) regimen for at least 4 weeks prior to study entry\n    * NOTE: ART includes drugs, which are NOT strong cytochrome P450 (CYP)3A4 inducers (participants receiving ART that are strong CYP3A4 inducers are not eligible to be included in the study)\n    * HIV screening tests are not required unless:\n\n      * Known history of HIV infection\n      * As mandated by local health authority or institutional standards\n    * Are compliant with their ART\n  * Adequate organ function as defined. Specimens must be collected within 10 days prior to treatment initiation with nemtabrutinib in both pre-CAR and post-CAR T phase\n  * Absolute neutrophil count (ANC) ≥ 500\u002FuL (within 10 days prior to treatment initiation with nemtabrutinib in both pre-CAR and post-CAR T phase)\n\n    \\* Growth factor (granulocyte colony-stimulating factor \\[GCSF\\] and thyroid peroxidase \\[TPO\\] agonist) and\u002For transfusion support is permissible to stabilize participant at least 7 days before screening or planned start of nemtabrutinib\n  * Platelets ≥ 25000\u002FuL (within 10 days prior to treatment initiation with nemtabrutinib in both pre-CAR and post-CAR T phase)\n\n    \\* Growth factor (GCSF and TPO agonist) and\u002For transfusion support is permissible to stabilize participant at least 7 days before screening or planned start of nemtabrutinib\n  * Hemoglobin ≥ 7 g\u002FdL (within 10 days prior to treatment initiation with nemtabrutinib in both pre-CAR and post-CAR T phase)\n\n    \\* Growth factor (GCSF and TPO agonist) and\u002For transfusion support is permissible to stabilize participant at least 7 days before screening or planned start of nemtabrutinib\n  * Creatinine ≤ 1.5 x upper limit of normal (ULN) (within 10 days prior to treatment initiation with nemtabrutinib in both pre-CAR and post-CAR T phase) OR measured or calculated creatinine clearance ≥ 30 mL\u002Fmin for participant with creatinine levels \\> 1.5 x institutional ULN (glomerular filtration rate \\[GFR} can also be used in place of creatinine or creatinine clearance \\[CrCl\\])\n\n    \\* Creatinine clearance (CrCl) should be calculated per institutional standard\n  * Total bilirubin ≤ 1.5 x ULN (within 10 days prior to treatment initiation with nemtabrutinib in both pre-CAR and post-CAR T phase) OR direct bilirubin ≤ ULN for participants with total bilirubin levels \\> 1.5 x ULN\n  * Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \\[SGOT\\]) and alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 5 x ULN (within 10 days prior to treatment initiation with nemtabrutinib in both pre-CAR and post-CAR T phase)\n  * International normalized ratio (INR) OR prothrombin time (PT) activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN (within 10 days prior to treatment initiation with nemtabrutinib in both pre-CAR and post-CAR T phase) unless participant is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants\n  * Participants assigned male sex at birth\n\n    \\* If capable of producing sperm, the participant agrees to the following during the intervention period and for at least the time needed to eliminate each study intervention after the last dose of study intervention. The length of time required to continue contraception for each study intervention is:\n    * Nemtabrutinib: 12 days\n    * Cyclophosphamide: 4 months\n    * Fludarabine: 3 months\n    * Abstains from penile-vaginal intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agrees to remain abstinent OR\n    * Uses contraception as detailed below unless confirmed to be azoospermic (vasectomized or secondary to medical cause, documented from the site personnel's review of the participant's medical records, medical examination, or medical history interview) as detailed below:\n\n      \\*\\*\\* Uses a penile\u002Fexternal condom plus nonparticipant of childbearing potential who is not currently pregnant and should also be advised of the benefit for that partner to use an additional method of contraception, as a condom may break or leak\n\n      \\* Note: Participants capable of producing ejaculate whose partner is pregnant, or breastfeeding must agree to use penile\u002Fexternal condom during each episode of sexual activity in which the partner is at risk of drug exposure via ejaculate\n    * Contraceptive use by participants capable of producing sperm should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. If the contraception requirements in the local label for any of the study interventions are more stringent than the requirements above, the local label requirements are to be followed\n  * Participants assigned female sex at birth\n\n    * A participant assigned female sex at birth is eligible to participate if not pregnant or breastfeeding, and at least one of the following conditions applies:\n\n      * Is not a person of childbearing potential (POCBP) OR\n      * Is a POCBP and:\n      * Uses a contraceptive method that is highly effective (with a failure rate of \\\u003C 1% per year), with low user dependency, or is abstinent from penile-vaginal intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), during the intervention period and for at least the time needed to eliminate each study intervention after the last dose of study intervention. The length of time required to continue contraception for each study intervention is:\n\n        * Nemtabrutinib: 1 month\n        * Cyclophosphamide: 12 months\n        * Fludarabine: 6 months\n      * The investigator should evaluate the potential for contraceptive method failure (ie, noncompliance, recently initiated) in relationship to the first dose of study intervention. Contraceptive use by POCBPs should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. If the contraception requirements in the local label for any of the study interventions are more stringent than the requirements above, the local label requirements are to be followed\n      * Has a negative highly sensitive pregnancy test (urine or serum) as required by local regulations within 24 hours (for urine test) or 72 hours (for serum test) before the first dose of study intervention. If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive\n      * Abstains from breastfeeding during the study intervention period and for at least 30 days after study intervention with nemtabrutinib\n      * Medical history, menstrual history, and recent sexual activity has been reviewed by the investigator to decrease the risk for inclusion of a POCBP with an early undetected pregnancy\n\nExclusion Criteria:\n\n* • Gastrointestinal dysfunction that may affect drug absorption (e.g., gastric bypass surgery, gastrectomy)\n\n  * Diagnosis of Richter transformation including any history of Richter's transformation\n  * Active central nervous system (CNS) involvement with lymphoma. Previously treated CNS disease allowed as long as confirmed disease control based on imaging and negative cerebrospinal fluid (CSF) cytology\n  * Active infection requiring systemic therapy, including IV antibiotics during screening. Participants may be rescreened following completion of IV antibiotic course (24 hour washout period required). PO antibiotics are allowed if infection is considered controlled by treating physician\n  * AIDS defining opportunistic infection in the past 12 months prior to screening\n  * History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator\n  * Corrected QT interval (QTc) prolongation (defined as a Fridericia's formula-corrected QT interval \\[QTcF\\] \\> 450 msecs) or other significant electrocardiogram (ECG) abnormalities including second degree atrioventricular (AV) block type II, third degree AV block, or bradycardia (ventricular rate less than 50 beats\u002Fmin)\n  * Known allergy\u002Fsensitivity (≥ grade 3) to nemtabrutinib or any of the excipients\n  * History of severe bleeding disorder defined as an ongoing congenital or acquired condition that leads to an increased likelihood of bleeding\n  * History of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years\n\n    \\* NOTE: The time requirement does not apply to participants who underwent successful definitive resection of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ of bladder or cervix\n  * A POCBP who has a positive urine pregnancy test within 72 hours prior to allocation. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n\n    \\* Note: in the event that 72 hours have elapsed between the screening pregnancy test and the first dose of study treatment, another pregnancy test (urine or serum) must be performed and must be negative in order for subject to start receiving study medication\n  * Patients with refractory MCL to non-covalent BTK inhibitor such as pirtobrutinib or nemtabrutinib. Patients who have relapsed or refractory MCL after prior covalent BTK inhibitors are allowed. Patients who have received prior non-covalent BTK inhibitors and achieved at least partial response are allowed\n  * Currently being treated with the following drugs:\n\n    * P-glycoprotein (P-gp) substrates with a narrow therapeutic index\n    * CYP3A strong inducers\n    * CYP3A strong inhibitors\n    * NOTE: A washout period of at least 5 times the half-life after the last dose of any of the above treatments is required for a participant to be eligible for study enrollment\n  * Has received prior systemic anti-cancer therapy including investigational agents within 2 weeks or 5 half-lives before start of study treatment (whichever is shorter). Subjects can be screened pending required wash-out period before starting nemtabrutinib\n  * Has received prior radiotherapy within 2 weeks of start of study intervention or has radiation-related toxicities requiring corticosteroids\n\n    \\* NOTE: Two weeks or fewer of palliative radiotherapy for non-CNS disease, with a 1-week washout, is permitted\n  * Has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed\n  * Is currently enrolled on another therapeutic clinical trial. Concurrent enrollment on another therapeutic clinical trial or any trial designed to impact the efficacy of anti-cancer therapy is prohibited\n  * Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration\n  * Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication. Hypogammaglobulinemia will not be considered state of immunodeficiency\n  * Has active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid)\n  * Has not adequately recovered after 4 weeks from major surgery or has ongoing surgical complications\n\n    \\* NOTE: Biopsy and placement of central venous access devices are not considered major surgery\n  * Has a history or current evidence of any condition, therapy, or laboratory abnormality or other circumstance that might confound the results of the study, interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator\n  * Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial","ALL","18 Years",{"count":7,"type":20},"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This phase II trial tests the effect of nemtabrutinib in combination with brexucabtagene autoleucel (brexu-cel) in treating patients with mantle cell lymphoma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Nemtabrutinib, a BTK inhibitor, may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Chimeric antigen receptor (CAR) T-cell therapy, such as brexu-cel, is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added to the T cells in the laboratory. The special receptor is called a CAR. Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. Chemotherapy, such as fludarabine and cyclophosphamide, are given before CAR T cell therapy to help kill cancer cells in the body and help make room for the CAR T cells. Giving nemtabrutinib in combination with brexu-cel may be safe, tolerable, and\u002For effective in treating patients with relapsed or refractory mantle cell lymphoma.",[26,27],"Recurrent Mantle Cell Lymphoma","Refractory Mantle Cell Lymphoma","NOT_YET_RECRUITING","2026-06-29",{"date":31,"type":32},"2026-07-01","ACTUAL",{"date":34,"type":20},"2026-07-31",{"date":36,"type":20},"2032-07-31",{"name":38,"class":39},"Vanderbilt-Ingram Cancer Center","OTHER",1,{"id":42,"slug":43,"hasResults":12,"nctId":44,"briefTitle":45,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":21,"phases":49,"briefSummary":51,"conditions":52,"keywords":64,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":40},"100628371","phase-1-safety-and-feasibility-of-nivolumab-irdye800cw-in-patients-with-head-and-neck-squamous-cell-carcinoma-hnscc-100628371","NCT07460765","Safety and Feasibility of Nivolumab-IRDye800CW in Patients With Head and Neck Squamous Cell Carcinoma (HNSCC)","Inclusion Criteria:\n\n* Written informed consent\n* Age ≥ 18 years\n* Participants must have biopsy proven HNSCC or imaging of diagnostic of recurrent cancer or undergoing surgical excision for presumed HNSCC.\n* Adequate hematologic and end-organ function appropriate for surgical resection and anesthesia (within 30 days of infusion).\n* Karnofsky performance status of at least 70% or Eastern Cooperative Oncology Group (ECOG)\u002FZubrod level 0-2.\n* Negative hepatitis B surface antigen (HBsAg) test at screening\n\nExclusion Criteria:\n\n* Patients not planning for SOC surgical resection\n* Active or history of autoimmune disease or immune deficiency, including, but not limited to, HIV, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis with the following exceptions:\n\n  1. Patients with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study.\n  2. Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.\n  3. Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided if all the following conditions are met:\n\n     1. Rash must cover \\\u003C 10% of body surface area\n     2. Disease is well controlled at baseline and requires only low-potency topical corticosteroids\n     3. No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency oral corticosteroids within the previous 12 months\n* History of hepatitis C that has not been treated with curative intent.\n* History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan on active systemic therapy.\n* History of radiation pneumonitis in the radiation field (fibrosis) is permitted.\n* Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina.\n* Severe unresolved infection within 4 weeks prior to initiation of study treatment.\n* Prior allogeneic stem cell or solid organ transplantation.\n* History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins\n* Chronic treatment with systemic immunosuppressive medication in excess of physiologic maintenance doses of corticosteroids (\\>10 mg\u002Fday of prednisone or equivalent) (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF-a agents), with the following exceptions:\n\n  1. Patients who received acute, systemic immunosuppressant medication or a dose of systemic immunosuppressant medication are eligible for the study.\n  2. Physiologic corticosteroid replacement therapy at doses ≤ 10 mg\u002Fday of prednisone or equivalent for adrenal or pituitary insufficiency and in the absence of active autoimmune disease is permitted.\n  3. Patients with asthma that requires intermittent use of bronchodilators, inhaled steroids, or steroid injections may participate. Pulse oral steroids of ≤5 days is permitted if \\>30 days from first infusion.\n  4. Patients using topical, ocular, intra-articular, or intranasal steroids (with minimal systemic absorption) may participate.\n  5. Brief courses of corticosteroids for prophylaxis (e.g., contrast dye allergy) or study treatment-related standard premedication is permitted.\n* Pregnant or breastfeeding, or intention of becoming pregnant during study treatment or within 2 months after the final dose of study drug administration.\n* Participants presenting with a baseline QTcF interval \\> than 480 milliseconds.",{"count":48,"type":20},40,[50],"PHASE1","This is a phase 1, open-label, single-center study that plans to enroll 40 participants who will undergo surgical resection as SOC for HNSCC. This trial is designed to evaluate the safety of the safety of fluorescently labeled nivolumab (nivo800) as a molecular imaging agent. The study employs a dose-escalation design across four cohorts of 10 participants each. Participants in Cohorts 1-3 will receive an infusion of nivo followed by an infusion of nivo800 prior to standard-of-care surgical resection. The administration of unlabeled nivo will be administered approximately 2-3 weeks before surgery, followed by an administration of nivo800 administered 1-2 days prior to surgery.",[53,54,55,56,57,58,59,60,61,62,63],"Hnscc","Head and Neck","Squamous Cell Cancer","Squamous Carcinoma","Squamous Cell Cancer of Head and Neck (SCCHN)","Squamous Cell Carcinoma Head and Neck Cancer (HNSCC)","Squamous Cell Carcinoma Mouth","Squamous Carcinoma Poorly Differentiated","Squamous Cell Cancer of the Head and Neck","Squamous Cell Carcinoma (SCC) of the Oral Cavity","Squamous Cell Carcinoma (SCC)",[65,66,67,68,69,70,71,72,73],"nivo800","neoadjuvant","surgery","head and neck cancer","head and neck","surgical resection","oral cancer","SCC","HNSCC","RECRUITING","2026-06-26",{"date":77,"type":32},"2026-06-30",{"date":79,"type":20},"2026-07",{"date":81,"type":20},"2031-04",{"name":38,"class":39},{"id":84,"slug":85,"hasResults":12,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":4,"eligibilityCriteria":89,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":90,"targetDuration":4,"studyType":21,"phases":92,"briefSummary":93,"conditions":94,"keywords":4,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},"100546798","phase-1-eltanexor-and-venetoclax-in-relapsed-or-refractory-myelodysplastic-syndrome-and-acute-myeloid-leukemia-100546798","NCT06399640","Eltanexor and Venetoclax in Relapsed or Refractory Myelodysplastic Syndrome and Acute Myeloid Leukemia","Phase Ib Study of Eltanexor and Venetoclax in Relapsed or Refractory Myelodysplastic Syndrome and Acute Myeloid Leukemia","Inclusion Criteria:\n\n\\- Age \\>\u002F= 18 years at the time of signing the Informed Consent Form (ICF); must voluntarily sign an ICF; and must be able to meet all study requirements.\n\nFor Myelodysplastic Syndrome (MDS):\n\nMorphologically confirmed diagnosis of MDS with increased blasts (\\>\u002F= 5%), with a prior DNA methyltransferase inhibitor (DNMTi) treatment and progression after 2 cycles or stable disease after 4 cycles\n\nFor Acute Myeloid Leukemia (AML):\n\nMorphologically confirmed diagnosis of AML in accordance with WHO diagnostic criteria that is relapsed or refractory following \\>\u002F= 1 line(s) of therapy.\n\n* WBC must be less than 25,000\u002Ful prior to study start (hydroxyurea allowed).\n* A bone marrow aspirate must be performed, and tissue collected for entrance to the trial unless circulating blasts \\>\u002F= 5% in which case, peripheral blood can be used.\n* Eastern Cooperative Oncology Group Performance Status of 0 - 2.\n* Must have adequate hepatic and renal function as demonstrated by the following:\n\nALT(SGPT) and\u002For AST (SGOT) \\\u003C\u002F= 3x upper limit of normal (ULN); Direct bilirubin \\\u003C\u002F= 1.5 x ULN; or Total bilirubin \\\u003C\u002F= 2.5x ULN (known Gilbert's Syndrome as cause of elevated bilirubin is allowed); Calculated creatinine clearance \\> 50 ml\u002Fmin (per the Cockroft-Gault formula).\n\n\\- Willingness to abide by all study requirements, including contraception, maintenance of a pill diary, and acceptance of recommended supportive care medications.\n\nExclusion Criteria:\n\n* Anticancer therapy, including investigational agents \\\u003C\u002F= 2 weeks or \\\u003C\u002F= 5 half-lives of the drug, whichever is shorter, prior to C1D1. (Use of hydroxyurea is permitted).\n* Inadequate recovery from toxicity attributed to prior anti-cancer therapy to \\\u003C\u002F= Grade 1 (NCI CTCAE v5.0), excluding alopecia or fatigue.\n* Prior treatment with SINE compounds or other inhibitors of XPO1.\n* History of allogeneic hematopoietic stem cell transplant (HCT), or other cellular therapy product, within 3 months.\n* Active acute or chronic GVHD requiring calcineurin inhibitors or steroid dosing \\>\u002F= 10mg\u002Fday or patients within 4 weeks of stopping calcineurin inhibitors for GVHD.\n* Radiation therapy or major surgery within 3 weeks.\n* Active, uncontrolled infection. Patients with infection under active treatment and controlled with antibiotics are eligible. Prophylaxis, even if parenteral, is acceptable.\n* Inability to swallow oral medications.\n* Active documented central nervous system leukemia.\n* Second active malignancy within past 2 years except for basal or squamous cell carcinoma of the skin, ductal carcinoma of breast in situ or cervical carcinoma in situ.\n* Women of childbearing age or potential must have negative pregnancy test and must not be actively breastfeeding to enroll on the study\n* Clinically significant cardiovascular disease with major event or cardiac intervention within the past 6 months (e.g. percutaneous intervention, coronary artery bypass graft, documented cardiac heart failure) as determined by the investigator.\n* Any condition not listed but deemed by the investigator to make the patient a poor candidate for clinical trial and\u002For treatment with investigational agents.",{"count":91,"type":20},60,[50],"This phase I trial tests the safety, side effects, and best dose of eltanexor in combination with venetoclax for the treatment of patients with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Eltanexor works by trapping \"tumor suppressing proteins\" within the cell, thus causing the cancer cells to die or stop growing. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving eltanexor together with venetoclax may be safe, tolerable and\u002For effective in treating patients with relapsed or refractory MDS or AML.",[95,96,97,98,99],"Relapsed Myelodysplastic Syndrome","Refractory Myelodysplastic Syndrome","Acute Myeloid Leukemia","Recurrent Acute Myeloid Leukemia","Refractory Acute Myeloid Leukemia","2026-06-19",{"date":102,"type":32},"2026-06-24",{"date":104,"type":32},"2024-08-14",{"date":106,"type":20},"2027-10-01",{"name":38,"class":39},2,{"id":110,"slug":111,"hasResults":12,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":4,"eligibilityCriteria":115,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":116,"targetDuration":4,"studyType":21,"phases":118,"briefSummary":120,"conditions":121,"keywords":4,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":128,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":40},"100517385","phase-4-surgical-debulking-prior-to-peptide-receptor-radionuclide-therapy-in-well-differentiated-gastroenteropancreatic-neuroendocrine-tumors-100517385","NCT06016855","Surgical Debulking Prior to Peptide Receptor Radionuclide Therapy in Well Differentiated Gastroenteropancreatic Neuroendocrine Tumors","Surgical Debulking Prior to Peptide Receptor Radionuclide Therapy (PRRT) in Patients With Well Differentiated Gastroenteropancreatic Neuroendocrine Tumors","Inclusion Criteria:\n\n* Signed and dated written informed consent\n* Male or female \\>= 18 years of age on the day of signing informed consent\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2\n* Histologically confirmed well-differentiated gastrointestinal or pancreatic neuroendocrine tumor that is grade 1 or grade 2 (Ki-67 =\\\u003C 20%)\n* Somatostatin receptor avidity of known or suspected neuroendocrine tumor (NET) lesion(s) assessed by a baseline copper-64 dotatate PET\u002FCT scan performed within 6 months (180 days) prior to surgical debulking on study day 0. The somatostatin receptor avidity of the majority of suspected NET lesion(s) must be \\>= normal liver uptake\n* Patient must have hepatic metastasis or hepatic metastases. Provided required hepatic metastatic disease is present, patient can also have any other site or sites of metastatic disease\n* White blood cell count (WBC) \\>= 2000\u002FuL (resulted =\\\u003C 90 days prior to surgical debulking on day 0 of participation in this study)\n* Platelets \\>= 75,000\u002FuL (resulted =\\\u003C 90 days prior to surgical debulking on day 0 of participation in this study)\n* Hemoglobin \\>= 8.0 g\u002FdL (resulted =\\\u003C 90 days prior to surgical debulking on day 0 of participation in this study)\n* Creatinine clearance (CrCl) \\>= 30 mL\u002Fminute (as calculated by the Cockcroft-Gault Formula with estimated creatinine clearance rate \\[eCCR\\] \\>= 30 mL\u002Fmin required for eligibility inclusion; or calculated\u002Fmeasured by an alternative established institutional standard consistently applied across participants at the site) (resulted =\\\u003C 90 days prior to surgical debulking on day 0 of participation in this study)\n* Total bilirubin =\\\u003C 3.0 times institutional upper limit of normal (ULN) (resulted =\\\u003C 90 days prior to surgical debulking on day 0 of participation in this study)\n* Serum albumin \\>= 3.0 g\u002FdL unless the prothrombin time is within normal range (resulted =\\\u003C 90 days prior to surgical debulking on day 0 of participation in this study)\n* Women must not be breastfeeding and further agree to not breastfeed during treatment with lutetium Lu 177 dotatate; and for at least 2.5 months after patient's final dose of lutetium Lu 177 dotatate\n* A woman of childbearing potential (WOCBP) - must have a negative serum or urine pregnancy test resulted within 28 days prior to initiation of first dose of lutetium Lu 177 dotatate on cycle 1, day 1; and must agree to follow instructions for using acceptable contraception from the time of signing consent, and until 7 months after her final dose of lutetium Lu 177 dotatate\n* A man able to father children who is sexually active with a WOCBP must agree to follow instructions for using acceptable contraception, from the time of signing consent, and until 4 months after his final dose of lutetium Lu 177 dotatate\n\nExclusion Criteria:\n\n* Patient has any tumor \\> 3 cm deemed to be inoperable\n* Patient has disease which is considered to be completely surgically resectable\n* Patient has grade 3 neuroendocrine neoplasm (well-differentiated or poorly-differentiated tumor)\n* Prior receipt of peptide receptor radionuclide therapy (PRRT)\n* Patient possesses untreated or growing brain metastases (growth within 90 days prior to surgical debulking on day 0 of participation in this study)\n* Unstable angina, congestive heart failure with New York Heart Association (NYHA) functional classification III or IV, or uncontrolled symptomatic cardiac arrythmia\n* Any other significant medical, psychiatric, or surgical condition, currently uncontrolled by treatment, which in the judgment of the patient's study physician may reasonably be expected to interfere with patient's completion of the study",{"count":117,"type":20},6,[119],"PHASE4","This phase IV trial evaluates how well giving standard of care (SOC) peptide receptor radionuclide therapy (PRRT) after SOC surgical removal of as much tumor as possible (debulking surgery) works in treating patients with grade 1 or 2, somatostatin receptor (SSTR) positive, gastroenteropancreatic neuroendocrine tumors (GEP-NETs) that have spread from where they first started (primary site) to the liver (hepatic metastasis). Lutetium Lu 177 dotatate is a radioactive drug that uses targeted radiation to kill tumor cells. Lutetium Lu 177 dotatate includes a radioactive form (an isotope) of the element called lutetium. This radioactive isotope (Lu-177) is attached to a molecule called dotatate. On the surface of GEP-NET tumor cells, a receptor called a somatostatin receptor binds to dotatate. When this binding occurs, the lutetium Lu 177 dotatate drug then enters somatostatin receptor-positive tumor cells, and radiation emitted by Lu-177 helps kill the cells. Giving lutetium Lu 177 dotatate after surgical debulking may better treat patients with grade 1\u002F2 GEP-NETs",[122,123,124,125,126,127],"Digestive System Neuroendocrine Tumor G1","Digestive System Neuroendocrine Tumor G2","Metastatic Digestive System Neuroendocrine Neoplasm","Metastatic Malignant Neoplasm in the Liver","Pancreatic Neuroendocrine Tumor G1","Pancreatic Neuroendocrine Tumor G2",{"date":102,"type":32},{"date":130,"type":32},"2024-05-31",{"date":132,"type":20},"2028-05-28",{"name":38,"class":39},{"id":135,"slug":136,"hasResults":12,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":4,"eligibilityCriteria":140,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":141,"targetDuration":4,"studyType":21,"phases":143,"briefSummary":144,"conditions":145,"keywords":4,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":148,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":40},"100498459","phase-2-circulating-tumor-dna-to-guide-changes-in-standard-of-care-chemotherapy-100498459","NCT05770531","Circulating Tumor DNA to Guide Changes in Standard of Care Chemotherapy","A Randomized Clinical Trial Comparing ctDNA-Directed Therapy Change With Standard of Care in Patients With Metastatic Triple Negative Breast Cancer","Inclusion Criteria:\n\n* Clinical stage IV (metastatic) estrogen receptor (ER), PR, HER2 negative invasive mammary carcinoma, previously documented by histological analysis and that meets the following criteria:\n\n  * HER2 negativity is defined as any of the following by local laboratory assessment:\n\n    * In-situ hybridization (ISH) non-amplified (ratio of HER2 to CEP17 \\\u003C 2.0 or\n    * Single probe average HER2 gene copy number \\\u003C 4 signals\u002Fcell), or\n    * Immunohistochemistry (IHC) 0 or IHC 1+ (if more than one test result is available and not all results meet the inclusion criterion definition, all results should be discussed with the sponsor-investigator to establish eligibility of the patient)\n  * ER and PR negativity are defined as =\\\u003C 10% of cells expressing hormonal receptors via IHC analysis\n* PD-L1 negative (combined positive score \\[CPS\\] \\\u003C 10) or otherwise not appropriate for checkpoint inhibitors\n* Patients must have measurable disease according to the standard RECIST version 1.1\n\n  \\* NOTE: CT scans or MRIs used to assess the measurable disease must have been completed with 28 days prior to the study drug initiation\n* Patients must be age \\>= 18 years; both male and female are eligible\n* Patients must exhibit an Eastern Cooperative Oncology Group (ECOG) performance status of =\\\u003C 2\n* Patients must have the ability to understand and the willingness to sign a written informed consent prior to registration on study\n* No prior chemotherapy regimens for metastatic disease\n* Absolute neutrophil count (ANC) \\>= 1000\u002Fmm\\^3 (obtained less than 28 days from initiation of study drug)\n* Platelet count \\>= 100,000\u002Fmm\\^3 (obtained less than 28 days from initiation of study drug)\n* Bilirubin, serum glutamic oxaloacetic transaminase (SGOT), serum glutatmic pyruvic transaminase (SGPT), alkaline phosphatase =\\\u003C 4x upper limits of normal if no liver metastases present\n* Serum total bilirubin must be \\\u003C 3x upper limits of normal for patients with Gilbert disease\n* Total bilirubin, SGOT, SGPT =\\\u003C 6x upper limits of normal if liver metastases present (obtained less than 28 days from initiation of study drug)\n* For patients who are not postmenopausal (women) or surgically sterile (absence of ovaries and\u002For uterus or vasectomy), agreement to remain abstinent or to use two adequate methods of contraception (e.g., condoms, diaphragm, vasectomy\u002Fvasectomized partner, tubal ligation), during the treatment period and for at least 30 days after the last dose of study treatment. Hormone based oral contraceptives are not allowed on study. Postmenopausal is defined as:\n\n  * Age \\>= 55 years\n  * Age =\\\u003C 55 years and amenorrheic for 12 months in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression; or follicle stimulating hormone and estradiol in the postmenopausal range\n\nExclusion Criteria:\n\n* Leptomeningeal disease\n* Uncontrolled tumor-related pain: patients requiring narcotic pain medication must be on a stable regimen at registration. Symptomatic lesions (e.g., bone metastases or metastases causing nerve impingement) amenable to palliative radiotherapy should be treated prior to randomization. Patients should be recovered from the effects of radiation. There is no required minimum recovery period. Asymptomatic metastatic lesions whose further growth would likely cause functional deficits or intractable pain (e.g., epidural metastasis that is not presently associated with spinal cord compression) should be considered for loco-regional therapy if appropriate prior to randomization\n* Uncontrolled hypercalcemia (\\> 1.5 mmol\u002FL ionized calcium or calcium \\> 12 mg\u002FdL or corrected serum calcium \\> upper limit of normal \\[ULN\\]) or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy\n* Malignancies other than TNBC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer)\n* Concurrent anti-cancer therapy (chemotherapy, radiation therapy, surgery, immunotherapy, biological therapy) other than the ones specified in the protocol\n* Women only: pregnancy or lactation\n* Evidence of significant uncontrolled concomitant disease that in the opinion of the investigator could affect compliance with the protocol or interpretation of results, including significant liver disease (such as cirrhosis, uncontrolled major seizure disorder, or superior vena cava syndrome)\n* Significant cardiovascular disease, such as New York Heart Association (NYHA) cardiac disease (class II or greater), myocardial infarction within 3 months prior to randomization, unstable arrhythmias, or unstable angina. Patients with a known left ventricular ejection fraction (LVEF) \\\u003C 35% will be excluded. Patients with known coronary artery disease or congestive heart failure not meeting the above criteria must be on a stable medical regimen that is optimized in the opinion of the treating physician, in consultation with a cardiologist if appropriate\n* Major surgical procedure within 4 weeks prior to randomization or anticipation of the need for a major surgical procedure during the course of the study other than for diagnosis. Placement of central venous access catheter(s) (e.g., port or similar) is not considered a major surgical procedure and is therefore permitted\n* Psychiatric illness\u002Fsocial situations that would compromise patient safety or limit compliance with study requirements",{"count":142,"type":20},160,[23],"This phase II trial tests how well evaluating circulating tumor deoxyribonucleic acid (ctDNA) works to guide therapy-change decisions in treating patients with triple-negative breast cancer (TNBC) that has spread from where it first started (primary site) to other places in the body (metastatic). This study wants to learn if small pieces of DNA associated with a tumor (called circulating tumor DNA, or ctDNA) can be detected in investigational blood tests during the course of standard chemotherapy treatment for breast cancer, and whether information from such investigational ctDNA blood testing could possibly be used as an early indication of chemotherapy treatment failure. It is hoped that additional information from investigational blood testing for ctDNA could help doctors to switch more quickly from a standard chemotherapy treatment that typically has significant side effects and which may not be working, to a different standard treatment regimen against TNBC, called sacituzumab govitecan. Sacituzumab govitecan is a monoclonal antibody, called hRS7, linked to a chemotherapy drug, called irinotecan. hRS7 is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as TROP2 receptors, and delivers irinotecan to kill them. Studying ctDNA may assist doctors to change therapy earlier if needed, and may improve health outcomes in patients with metastatic TNBC.",[146,147],"Metastatic HER2-Negative Breast Carcinoma","Metastatic Triple-Negative Breast Carcinoma",{"date":102,"type":32},{"date":150,"type":32},"2023-10-03",{"date":152,"type":20},"2028-10-01",{"name":38,"class":39},{"id":155,"slug":156,"hasResults":12,"nctId":157,"briefTitle":158,"officialTitle":158,"acronym":4,"eligibilityCriteria":159,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":160,"targetDuration":4,"studyType":21,"phases":161,"briefSummary":162,"conditions":163,"keywords":168,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":40},"100609626","phase-1-study-evaluating-18fnota-aby030-for-safety-and-tolerability-of-indeterminate-primary-andor-metastatic-disease-in-head-and-neck-squamous-cell-carcinoma-100609626","NCT07217028","Study Evaluating [18F]NOTA-ABY030 for Safety and Tolerability of Indeterminate Primary and\u002For Metastatic Disease in Head and Neck Squamous Cell Carcinoma","Inclusion Criteria:\n\n1. Age ≥ 18 years.\n2. Subjects diagnosed with any T stage, any subsite within the head and neck. Subjects with recurrent disease or a new primary will be allowed.\n3. Must have evidence of indeterminate metastatic and\u002For primary SCC based on clinical imaging or Primary SCC with suspicious Lymph Nodes standard image modalities prior to surgical removal\n4. Have acceptable lab values, including the following clinical results (if values are considered clinically significant per investigator, participants must be asymptomatic):\n\n   1. Hemoglobin ≥ 9gm\u002FdL\n   2. White blood cell count \\> 3000\u002Fmm3\n   3. Platelet count ≥ 100,000\u002Fmm3\n   4. Serum creatinine ≤ 1.5 times upper reference range\n   5. Potassium\n   6. Magnesium\n   7. Phosphorus\n\nExclusion Criteria:\n\n1. Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment.\n2. Prior severe infusion reactions or hypersensitivity to other monoclonal antibody therapies.\n3. Pregnant (based on Screening serum or urine pregnancy test administered before infusions), or breastfeeding.\n4. Participants with known hypersensitivity to NOTA-ABY-030, cetuximab, murine, or any of the drug components used in this trial.\n5. Subjects with history or evidence of interstitial pneumonitis or pulmonary fibrosis.\n6. Severe renal disease or anuria.\n7. Participants presenting with a baseline QTcF interval \\> than 480 milliseconds.\n8. Those with an allergy to red meat, a history of tick bites, and alpha-gal syndrome will be given extra consideration.",{"count":7,"type":20},[50],"This Phase I, single-institution, open-label study will evaluate the safety, tolerability, and diagnostic performance of \\[18F\\]NOTA-ABY030 PET\u002FCT in patients with head and neck squamous cell carcinoma (HNSCC) who present with indeterminate lesions on standard imaging. The investigational agent is a radiolabeled anti-EGFR affibody designed for rapid clearance and improved tumor-to-background contrast. All participants will receive a 50 mg cetuximab loading dose followed by a bolus of \\[18F\\]NOTA-ABY030, with PET\u002FCT imaging performed at defined intervals to assess biodistribution and lesion uptake. The primary objective is to determine safety and tolerability; secondary objectives include radiation dosimetry and comparison of sensitivity and specificity to conventional imaging modalities (MRI, CT, and \\[18F\\]FDG-PET\u002FCT). This approach aims to improve diagnostic accuracy, reduce unnecessary biopsies, and streamline treatment decisions for patients with HNSCC.",[164,165,166,167],"SCC - Squamous Cell Carcinoma","Radiotracer","Head and Neck Squamous Cell Carcinoma","Metastatic Head and Neck Squamous Cell Carcinoma",[169,170,171,172],"unknown primary","cancer","hnscc","scc","2026-05-06",{"date":175,"type":32},"2026-05-11",{"date":177,"type":32},"2026-04-24",{"date":179,"type":20},"2030-09",{"name":38,"class":39},{"id":182,"slug":183,"hasResults":12,"nctId":184,"briefTitle":185,"officialTitle":186,"acronym":4,"eligibilityCriteria":187,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":188,"targetDuration":4,"studyType":21,"phases":190,"briefSummary":192,"conditions":193,"keywords":197,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":207,"startDateStruct":209,"completionDateStruct":211,"leadSponsor":213,"locationsCount":40},"100586444","high-resolution-pet-ct-imaging-for-surgical-margin-visualization-100586444","NCT06915454","High-Resolution PET-CT Imaging for Surgical Margin Visualization","High-resolution Specimen PET-CT Imaging for the Intraoperative Visualization of Resection Margins: an Exploratory Study","Inclusion Criteria:\n\n* Biopsy confirmed diagnosis of any solid malignancy\n* Diagnosis of any T stage, any subsite that are scheduled to undergo definitive en bloc surgical resection. Patients with recurrent disease or a new primary will be allowed.\n* Planned standard of care oncologic surgery with curative intent\n* Male or female patients age ≥ 18 years\n* Have life expectancy of more than 12 weeks\n* Karnofsky performance status of at least 70% or ECOG\u002FZubrod level 1\n* Have acceptable glucose status (\\\u003C200 mg\u002FdL) at Day of Surgery prior to 18F-FDG injection\n\nExclusion Criteria:\n\n* General or local contraindications for resective surgery\n* Women who are pregnant or breast-feeding\n* Blood glucose level over 200 mg\u002FdL prior to 18F-FDG infusion\n* Any participation in other clinical trials or research study that involved a radiation exposure of more than 1 mSv in the past year. If the participant had radiation exposure greater than 1 mSv as SOC, they would not be excluded unless the Principal Investigator determines that patient could be at risk.",{"count":189,"type":20},50,[191],"NA","Imaging will be exploratory and be used intraoperatively. There have been no discovered risks associated with the device to be used in this study, and none are anticipated given the diagnostic and non-invasive, 'ex vivo' nature of device use. Of note, the surgical resection will proceed as per standard of care and will not be affected by the research protocol.\n\nPotential Benefit: Imaging intra-operatively will ensure surgeons to identify at risk resection margins.\n\nTime Commitment: There are no additional visits that will be asked of you to partake in this study.\n\nDrug is FDA approved and Exposure to Radiation is minimal.",[194,195,164,73,196],"Cancer","Solid Malignant Tumors","HNSCC,Larynx, Pharynx and Oral Cavity",[198,199,200,201,202,71,203,204,205,172,68,206,171],"undergoing surgery","Xeos","PET\u002FCT imaging","specimen scanner","cancer margins","mouth cancer","tongue cancer","gum cancer","pharynx",{"date":208,"type":32},"2026-05-08",{"date":210,"type":32},"2025-09-03",{"date":212,"type":20},"2027-07",{"name":38,"class":39},{"id":215,"slug":216,"hasResults":12,"nctId":217,"briefTitle":218,"officialTitle":218,"acronym":4,"eligibilityCriteria":219,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":220,"targetDuration":4,"studyType":21,"phases":222,"briefSummary":224,"conditions":225,"keywords":231,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":244,"startDateStruct":245,"completionDateStruct":247,"leadSponsor":249,"locationsCount":40},"100579768","early-phase-1-pilot-study-of-68gaga-aby-025-imaging-in-patients-undergoing-treatment-with-her2-targeted-therapy-100579768","NCT06828588","Pilot Study of [68Ga]Ga-ABY-025 Imaging in Patients Undergoing Treatment With HER2-targeted Therapy","Inclusion Criteria:\n\n1. Age ≥ 18 years.\n2. Patients with unresectable locally advanced or metastatic cancer who are eligible for standard of care treatment with HER2-targeted therapy per the discretion of their treating physician for an FDA-approved indication. Patients who are planning to start HER2-targeted therapy at the time of study enrollment. Patients who have recently begun HER2 treatment and have received no more than 6 cycles will be eligible for enrollment.\n3. Must have a previous biopsy demonstrating HER2 expression in at least one lesion (HER2+ solid cancer, or breast cancer patients who are HER2+ or HER2-low) as defined by IHC and FISH studies or with HER2 amplification as defined by a liquid biopsy that was done as standard of care testing for the patient's cancer type.\n4. Measurable disease on CT, FDG-PET, or MRI imaging for RECIST evaluation; patient must have measurable disease outside the liver.\n5. Life expectancy of at least 6 months. Patients with brain metastases are permitted to enroll in this study.\n\nExclusion Criteria:\n\n1. Measurable sites of disease only in the liver.\n2. Inability to comply with study procedures.\n3. Hypersensitivity or allergy to any component of \\[68Ga\\]Ga-ABY-025.\n4. Pregnant or breastfeeding.\n5. HER2-negative cancers that have no FDA approved indication for treatment with HER2-directed therapy.\n6. Inability to lie flat for 30 minutes during an imaging session.\n7. Medical or psychiatric co-morbidities that, in the opinion of the treating physician, would prevent the patient from successfully participating in the study.",{"count":221,"type":20},30,[223],"EARLY_PHASE1","The purpose of this study is to determine if the radiotracer, \\[68Ga\\]Ga-ABY-025, used for PET imaging can help us better identify and visualize lesions or tumors, in patients who are receiving standard of care therapy HER2+ cancers.",[226,227,228,229,230],"Locally Advanced Cancer","Metastatic Cancer","HER2","HER2 + Breast Cancer, HER2 + Gastric Cancer, Squamous Cell Carcinoma of Head and Neck, Esophageal Squamous Cell Carcinoma","HER 2 Low-expressing Breast Cancer",[228,170,232,233,234,235,236,237,238,239,240,241,242,243],"advanced cancer","metastatic","IHC","FISH","trastuzumab","T-DM1","Pertuzumab","Margetuximab","Neratinib","Lapatinib","Tucatinib","Everolimus",{"date":208,"type":32},{"date":246,"type":32},"2026-04-16",{"date":248,"type":20},"2029-12",{"name":38,"class":39},{"id":251,"slug":252,"hasResults":12,"nctId":253,"briefTitle":254,"officialTitle":254,"acronym":4,"eligibilityCriteria":255,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":256,"targetDuration":4,"studyType":21,"phases":258,"briefSummary":259,"conditions":260,"keywords":261,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":266,"startDateStruct":267,"completionDateStruct":269,"leadSponsor":271,"locationsCount":40},"100579048","early-phase-1-window-trial-of-fluorescently-labeled-panitumumab-panitumumab-irdye800-in-head-and-neck-cancer-100579048","NCT06819228","Window Trial of Fluorescently Labeled Panitumumab (Panitumumab-IRDye800) in Head and Neck Cancer","Inclusion Criteria:\n\n* Willing to review and sign written informed consent.\n* Male or female patients age \\> 18 years.\n* Tissue confirmation of head and neck squamous cell carcinoma.\n* Patients for whom a potentially curative resection is planned as standard of care.\n* ECOG performance status of 0 or 1\n* Adequate hematologic and end-organ function appropriate for surgery as determined by routine preoperative evaluation. If liver function, renal function and hematologic laboratory test results are acceptable for elective surgery, the patient is considered eligible for the study. Laboratory results that will need to be obtained within 30 days prior to initiation of study treatment: Magnesium, Phosphorus, serum pregnancy test (for females of childbearing age).\n* For women of childbearing potential: Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods as defined below:\n\n  • A woman is considered to be of childbearing potential if she is post-menarchal, has not reached a postmenopausal state (12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of the uterus and\u002For both ovaries and\u002For both fallopian tubes). Post-menarchal is defined as either:\n  * age \\>55 years old\n  * age \\\u003C55 years or less and\n* at least 12 months since last menstrual period,\n* at least 6 months since last menstrual period and FSH \\> 40 IU\n\n  * Women of childbearing potential must have a negative pregnancy test result within 14 days prior to initiation of study treatment.\n  * Women must remain abstinent or use effective contraceptive methods during the treatment period and for 5 months after the final dose of panitumumab.\n  * Men must agree to remain abstinent or use a condom during the treatment period and for 5 months after the final dose of panitumumab\u002Fpan800 to avoid exposing the embryo. Men must agree to refrain from donating sperm during this same period.\n\nExclusion Criteria:\n\n* Patients not eligible for standard of care surgical resection\n* Patients with a history of infusion reactions or allergic reactions to panitumumab.\n* History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan.\n\n  • History of radiation pneumonitis in the radiation field (fibrosis) is permitted.\n* Active tuberculosis. Patients do NOT have to be screened for tuberculosis for this trial.\n* Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina.\n* History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins.\n* Patients receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents. The following drugs are known to interact with panitumumab and therefore any patients taking these medications within 30 days will be ineligible for the trial.\n* Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 5 months after the final dose of study treatment.\n* Magnesium or phosphorus lower than normal institutional values, patient is symptomatic, and the values are unable to be corrected through standard repletion strategies.\n* Evidence of QT prolongation on pretreatment ECG.",{"count":257,"type":20},18,[223],"This study is exploring the use of Panitumumab in Head and Neck Cancer. Panitumumab is an approved drug named Vectibix and is used as an anti-cancer agent in other cancers such as colorectal cancer. It works by attaching to the cancer cell in a unique way that allows the drug to get into the cancer tissue. In addition to the Panitumumab, participants will also receive a Panitumumab-IRDye800 (Pan800) or a fluorescently labeled Panitumumab infusion. IRDye800 is an investigational dye that, when tested in the lab, helps various characteristics of human tissue show up better when using a special camera during surgery. Panitumumab-IRDye800 is a combination of the drug and the dye that attaches to cancer cells and appears to make them visible to the doctor when he or she uses the special camera during surgery.\n\nThe goal of this study is to use a novel and possibly safer approach to identify an optimal dose for panitumumab to treat cancer patients by using a new light-based therapy. In this study, different drug levels will be analyzed using this approach to understand how much drug reaches the tumor at different administered doses, which may help us provide safer and\u002For more effective therapies in the future.\n\nThe goal is to identify the correct amount or dose of a drug that is needed for effective cancer therapies. Often, clinical studies look at how much of the drug can be tolerated before patients become sick, rather than how much of the drug is required to be effective.\n\nIRDye800 is an investigational dye that, when tested in the lab, helps various characteristics of human tissue show up better when using a special camera during surgery. Panitumumab-IRDye800 is a combination of the drug and the dye that attaches to cancer cells and appears to make them visible to the doctor when he or she uses the special camera during surgery. This will help the surgeon with clinical margins during surgery and will may have a clearer way to differentiate between cancer and healthy tissue.",[73,196,164],[262,263,264,71,203,204,205,72,68,206,73,265],"Pan800","Panitumumab","Fluorescent guided surgery","larynx",{"date":208,"type":32},{"date":268,"type":32},"2025-04-17",{"date":270,"type":20},"2029-03",{"name":38,"class":39},{"id":273,"slug":274,"hasResults":12,"nctId":275,"briefTitle":276,"officialTitle":277,"acronym":4,"eligibilityCriteria":278,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":279,"targetDuration":4,"studyType":21,"phases":281,"briefSummary":282,"conditions":283,"keywords":4,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":288,"lastUpdatePostDateStruct":289,"startDateStruct":291,"completionDateStruct":293,"leadSponsor":295,"locationsCount":117},"100467051","phase-2-genetic-testing-to-select-therapy-for-the-treatment-of-advanced-or-metastatic-kidney-cancer-optic-rcc-study-100467051","NCT05361720","Genetic Testing to Select Therapy for the Treatment of Advanced or Metastatic Kidney Cancer, OPTIC RCC Study","Optimal Treatment by Invoking Biologic Clusters in Renal Cell Carcinoma (OPTIC RCC)","Inclusion Criteria:\n\n* Histological confirmation of RCC with a clear cell component\n* Advanced (not amenable to curative surgery or radiation therapy) or metastatic (American Joint Committee on Cancer \\[AJCC\\] stage IV) RCC\n* Patient can comprehend and sign the study informed consent form\n* Male or female \\>= 18 years of age at the time of informed consent\n* Karnofsky performance status (KPS) of \\>= 70%\n* No prior systemic therapy for RCC in the neoadjuvant, adjuvant or metastatic setting\n* At least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1\n* Tumor tissue for ribonucleic acid (RNA)-sequencing (tumor tissue from bony metastasis is not suitable but a soft tissue component around bone is acceptable)\n\n  * Screening tissue consent- Patient must be assigned to either Cluster 1\u002F2 or 4\u002F5. Patients assigned to cluster 3\u002F6\u002F7 will not be eligible for the treatment study\n* Adequate renal function defined as calculated creatinine clearance \\>= 30 mL\u002Fmin per the Cockcroft and Gault formula\n* Adequate liver function defined by:\n\n  * Total bilirubin =\\\u003C 1.5 times the upper limit of normal (ULN) except for unconjugated hyperbilirubinemia of Gilbert's syndrome\n  * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\\\u003C 3 x ULN\n* Women of childbearing potential (WOCBP) must have a negative serum pregnancy test during screening and prior to receiving first dose of protocol-indicated treatment\n\n  * Women of childbearing potential (WOCBP) is defined as any female who has experienced menarche who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or is not postmenopausal\n  * Menopause is defined clinically as 12 months of amenorrhea in a woman over 45 years of age in the absence of other biological or physiological causes\n\nExclusion Criteria:\n\n* =\\\u003C 14 days before first dose of protocol-indicated treatment:\n\n  * Major surgery requiring general anesthesia\n* Inadequately controlled hypertension (systolic blood pressure \\[SBP\\] \\> 160\u002F90 mmHg)\n\n  * Anti-hypertensive medications are permitted.\n* Active infection requiring infusional treatment\n* Has preexisting gastrointestinal or non-gastrointestinal fistula\n* Proteinuria \\> 2 g\u002F 24 hours (hrs)\n\n  * If patient has 1+ protein on urine dipstick then a 24 hr urine collection is required\n* Non-healing wounds on any part of the body (for patients assigned to Cabo\u002FNivo only)\n* Known clinically significant active bleeding including hemoptysis\n* Inability to swallow oral medication; or the presence of a poorly controlled gastrointestinal disorder that could significantly affect the absorption of oral study drug (for patients assigned to Cabo\u002FNivo only) - e.g., Crohn's disease, ulcerative colitis, chronic diarrhea (defined as \\> 4 loose stools per day), malabsorption, or bowel obstruction\n* Significant cardiovascular disease or condition including:\n\n  * Class III or IV cardiovascular disease according to the New York Heart Association (NYHA) functional criteria\n  * Unstable angina pectoris (i.e., last episode =\\\u003C 3 months prior to first dose of protocol-indicated treatment)\n  * Myocardial infarction within 3 months prior to starting treatment\n* Subjects with central nervous system (CNS) metastases are eligible after they have completed local therapy (e.g., whole brain radiation therapy \\[WBRT\\], surgery or radiosurgery)\n* Any condition requiring systemic treatment with either systemic corticosteroids (\\> 10 mg\u002Fday prednisone or equivalent daily) or other immunosuppressive medications within 14 days prior to initiating protocol-indicated treatment\n* In the absence of active autoimmune disease: Subjects are permitted the use of corticosteroids with minimal systemic absorption (e.g., topical, ocular, intra-articular, intranasal, and inhalational), =\\\u003C 10 mg\u002Fday prednisone or equivalent daily; and physiologic replacement doses of systemic corticosteroids =\\\u003C 10 mg\u002Fday prednisone or equivalent daily (e.g., hormone replacement therapy needed in patients with hypophysitis)",{"count":280,"type":20},54,[23],"This phase II trial tests whether using genetic testing of tumor tissue to select the optimal treatment regimen works in treating patients with clear cell renal cell (kidney) cancer that has spread to other places in the body (advanced or metastatic). The current Food and Drug Administration (FDA)-approved regimens for advanced kidney cancer fall into two categories. One treatment combination includes two immunotherapy drugs (nivolumab plus ipilimumab), which are delivered by separate intravenous infusions into a vein. The other combination is one immunotherapy drug (nivolumab infusion) plus an oral pill taken by mouth (cabozantinib). Nivolumab and ipilimumab are \"immunotherapies\" which release the brakes of the immune system, thus allowing the patient's own immune system to better kill cancer cells. Cabozantinib is a \"targeted therapy\" specifically designed to block certain biological mechanisms needed for growth of cancer cells. In kidney cancer, cabozantinib blocks a tumor's blood supply. The genetic (DNA) makeup of the tumor may affect how well it responds to therapy. Testing the makeup (genes) of the tumor, may help match a treatment (from one of the above two treatment options) to the specific cancer and increase the chance that the disease will respond to treatment. The purpose of this study is to learn if genetic testing of tumor tissue may help doctors select the optimal treatment regimen to which advanced kidney cancer is more likely to respond.",[284,285,286,287],"Advanced Clear Cell Renal Cell Carcinoma","Metastatic Clear Cell Renal Cell Carcinoma","Stage III Renal Cell Cancer AJCC v8","Stage IV Renal Cell Cancer AJCC v8","2026-04-21",{"date":290,"type":32},"2026-04-27",{"date":292,"type":32},"2022-12-06",{"date":294,"type":20},"2027-07-01",{"name":38,"class":39},{"id":297,"slug":298,"hasResults":12,"nctId":299,"briefTitle":300,"officialTitle":301,"acronym":4,"eligibilityCriteria":302,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":303,"targetDuration":4,"studyType":305,"phases":4,"briefSummary":306,"conditions":307,"keywords":309,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":288,"lastUpdatePostDateStruct":311,"startDateStruct":312,"completionDateStruct":314,"leadSponsor":316,"locationsCount":108},"100125271","molecular-predictors-of-cancer-in-patients-at-high-risk-of-lung-cancer-100125271","NCT00898313","Molecular Predictors of Cancer in Patients at High Risk of Lung Cancer","Molecular Predictors of Lung Cancer Behavior","Inclusion Criteria:\n\n-All adults referred to Vanderbilt Medical Center, Veterans Administration Medical Center, St. Thomas Hospital and Meharry Medical Center for evaluation of signs or symptoms of lung cancer.\n\nExclusion Criteria:\n\n* Inability to provide informed consent\n* Minors\n* Pregnant women",{"count":304,"type":20},4000,"OBSERVATIONAL","RATIONALE: Using samples of blood, urine, sputum, and lung tissue from patients at high risk of cancer for laboratory studies may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.\n\nPURPOSE: This research study is looking at molecular predictors of cancer in patients at high risk of lung cancer.",[308],"Lung Cancer",[310],"lung cancer",{"date":290,"type":32},{"date":313,"type":4},"2003-12",{"date":315,"type":20},"2027-01-31",{"name":38,"class":39},{"id":318,"slug":319,"hasResults":12,"nctId":320,"briefTitle":321,"officialTitle":321,"acronym":4,"eligibilityCriteria":322,"healthyVolunteers":12,"sex":17,"minAge":323,"maxAge":4,"enrollmentInfo":324,"targetDuration":4,"studyType":21,"phases":325,"briefSummary":326,"conditions":327,"keywords":4,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":329,"lastUpdatePostDateStruct":330,"startDateStruct":332,"completionDateStruct":334,"leadSponsor":336,"locationsCount":40},"100508524","phase-1-evaluating-111in-panitumumab-for-nodal-staging-in-head-and-neck-cancer-100508524","NCT05901545","Evaluating 111In Panitumumab for Nodal Staging in Head and Neck Cancer","Inclusion Criteria:\n\n* Age ≥ 19 years.\n* Biopsy-confirmed diagnosis of squamous cell carcinoma of the head and neck, clinically-staged as node-negative (cN0) or as clinically-suspicious node(s).\n* Subjects diagnosed with any T stage, any subsite within the head and neck that are scheduled to undergo surgical resection. Subjects with recurrent disease or a new primary will be allowed.\n* Planned standard of care elective neck dissection for node-negative or node-positive disease.\n* Have acceptable hematologic status, kidney function, and liver function including the following clinical results:\n\n  * Hemoglobin ≥ 9 gm\u002FdL\n  * White blood cell count \\> 3000\u002Fmm\\^3\n  * Platelet count ≥ 100,000\u002Fmm\\^3\n  * Serum creatinine ≤ 1.5 times upper reference range\n\nExclusion Criteria:\n\n* Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment.\n* History of infusion reactions to monoclonal antibody therapies\n* History of allergies to iodine\n* Pregnant or breastfeeding.\n* Magnesium or potassium lower than the normal institutional values.\n* Subjects receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents.\n* Subjects with a history or evidence of interstitial pneumonitis or pulmonary fibrosis.\n* Severe renal disease or anuria.","19 Years",{"count":221,"type":20},[50],"This phase I trial tests the safety and effectiveness of indium In 111 panitumumab (111In-panitumumab) for identifying the first lymph nodes to which cancer has spread from the primary tumor (sentinel lymph nodes) in patients with head and neck squamous cell carcinoma (HNSCC) undergoing surgery. The most important factor for survival for many cancer types is the presence of cancer that has spread to the lymph nodes (metastasis). Lymph node metastases in patients with head and neck cancer reduce the 5-year survival by half. Sometimes, the disease is too small to be found on clinical and imaging exams before surgery. 111In-panitumumab is in a class of medications called radioimmunoconjugates. It is composed of a radioactive substance (indium In 111) linked to a monoclonal antibody (panitumumab). Panitumumab binds to EGFR receptors, a receptor that is over-expressed on the surface of many tumor cells and plays a role in tumor cell growth. Once 111In-panitumumab binds to tumor cells, it is able to be seen using an imaging technique called single photon emission computed tomography\u002Fcomputed tomography (SPECT\u002FCT). SPECT\u002FCT can be used to make detailed pictures of the inside of the body and to visualize areas where the radioactive drug has been taken up by the cells. Using 111In-panitumumab with SPECT\u002FCT imaging may improve identification of sentinel lymph nodes in patients with head and neck squamous cell cancer undergoing surgery.",[166,328],"Recurrent Head and Neck Squamous Cell Carcinoma","2026-03-03",{"date":331,"type":32},"2026-03-05",{"date":333,"type":32},"2023-08-22",{"date":335,"type":20},"2029-11-30",{"name":38,"class":39},{"id":338,"slug":339,"hasResults":12,"nctId":340,"briefTitle":341,"officialTitle":342,"acronym":4,"eligibilityCriteria":343,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":344,"targetDuration":4,"studyType":21,"phases":345,"briefSummary":346,"conditions":347,"keywords":4,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":350,"lastUpdatePostDateStruct":351,"startDateStruct":353,"completionDateStruct":355,"leadSponsor":357,"locationsCount":40},"100561664","cryodevitalization-for-the-treatment-of-early-stage-lung-cancer-crystal-trial-100561664","NCT06593106","Cryodevitalization for the Treatment of Early Stage Lung Cancer, CRYSTAL Trial","The CRYSTAL Study: Cryodevitalization Study for the Treatment of Early-Stage Lung Cancer","Inclusion Criteria:\n\n* Patients with a single pulmonary nodule with a size less than or equal to three centimeters (average long and short axis) confirmed as malignant intraprocedurally (rapid on-site evaluation with pathology assessment showing lung cancer or oligometastatic disease) without evidence of mediastinal involvement who require nodule biopsy prior to proceeding with surgical resection\n* Nodules must be located in the outer 2\u002F3 of the periphery of the lung, greater than 10 mm from the pleura and from large blood vessels or mediastinal structures to avoid injury to other visceral organs\n* Patients deemed to have a surgical resection treatment option based on preoperative staging computed tomographic (CT), postoperative predicted forced expiratory volume in 1 second (FEV1) \\> 40% and evaluation of medical comorbidities after discussion at multidisciplinary tumor board\n* Age \\> 18 years old\n\nExclusion Criteria:\n\n* Target nodule is within the International Association for the Study of Lung Cancer (IASLC) \"central zone\" (including bronchial tree, major vessels, heart, esophagus, spinal cord and phrenic \\& laryngeal nerves), or are \\\u003C 10 mm from the pleura\n* Patients with an expected survival less than 6 months\n* Patients with endobronchial lesions, concerning for malignancy, visualized during the initial bronchoscopic evaluation of the airways\n* Patients with medically uncorrectable coagulopathy: abnormal platelet count \\\u003C 100 × 10\\^9\u002FL or an international normalized ratio \\> 1.5\n* Patients with known pulmonary hypertension (PASP \\[pulmonary artery systolic pressure\\] \\> 50mmHg)\n* Patients who are currently prescribed anticoagulants, clopidogrel, or other platelet aggregation inhibitors\n* Patients with medical comorbidities deemed high-risk for surgical resection\n* Pregnant women\n* Inability to provide informed consent",{"count":221,"type":20},[191],"This clinical trial studies side effects and best treatment time of cryodevitalization in treating patients with early stage (stage I or stage II) lung cancer. Cryodevitalization is a type of cryosurgery that uses a flexible probe (cryoprobe) to kill tumor cells by freezing them. It is delivered at the time of standard diagnostic robotic bronchoscopy. Using cryodevitalization may be safe, tolerable and\u002For effective in treating patients with early stage lung cancer.",[348,349],"Stage I Lung Cancer","Stage II Lung Cancer","2026-01-29",{"date":352,"type":32},"2026-02-02",{"date":354,"type":32},"2024-09-27",{"date":356,"type":20},"2026-08-31",{"name":38,"class":39},{"id":359,"slug":360,"hasResults":12,"nctId":361,"briefTitle":362,"officialTitle":363,"acronym":364,"eligibilityCriteria":365,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":366,"targetDuration":4,"studyType":21,"phases":368,"briefSummary":369,"conditions":370,"keywords":4,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":350,"lastUpdatePostDateStruct":371,"startDateStruct":372,"completionDateStruct":374,"leadSponsor":376,"locationsCount":40},"100524213","phase-4-ebus-tbna-vs-transbronchial-mediastinal-cryobiopsy-for-adequacy-of-next-generation-sequencing-100524213","NCT06105801","EBUS-TBNA vs Transbronchial Mediastinal Cryobiopsy for Adequacy of Next Generation Sequencing","A Multicenter Randomized Trial of EBUS-TBNA Versus Transbronchial Mediastinal Cryobiopsy for Adequacy of Next Generation Sequencing","FROSTBITE-3","Inclusion Criteria:\n\n* Lesions on PET or CT concerning for primary or metastatic malignancy that are amenable to biopsy by linear EBUS\n* Malignant cells present on rapid on-site cytological evaluation (ROSE)\n\nExclusion Criteria:\n\n* Patient is known to be less than 18 years old\n* Patient is known to be pregnant\n* Patient is known to be a prisoner\n* Operator deems lesion is not safe to biopsy",{"count":367,"type":20},250,[119],"This is a multi-center clinical trial evaluating the effect of transbronchial mediastinal cryobiopsy for its ability to improve the likelihood of obtaining tissue sufficient for molecular analysis. Patients in outpatient clinics or pre-operative holding areas planning to undergo a bronchoscopic biopsy of a suspected malignant lesion (peripheral or mediastinal) for initial diagnosis, staging, or tissue acquisition for molecular analysis will be considered for enrollment and consented. Patients will only be enrolled if intraoperative ROSE suggests malignancy. Patients will be randomized to continue with the operator's initial EBUS-TBNA needle or switch to a cryoprobe to perform a sampling.",[308],{"date":352,"type":32},{"date":373,"type":32},"2024-09-13",{"date":375,"type":20},"2028-10-31",{"name":38,"class":39},{"id":378,"slug":379,"hasResults":12,"nctId":380,"briefTitle":381,"officialTitle":382,"acronym":4,"eligibilityCriteria":383,"healthyVolunteers":12,"sex":17,"minAge":323,"maxAge":4,"enrollmentInfo":384,"targetDuration":4,"studyType":21,"phases":385,"briefSummary":386,"conditions":387,"keywords":4,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":388,"lastUpdatePostDateStruct":389,"startDateStruct":391,"completionDateStruct":392,"leadSponsor":394,"locationsCount":40},"100511932","phase-1-evaluating-the-use-of-dual-imaging-techniques-for-detection-of-disease-in-patients-with-head-and-neck-cancer-100511932","NCT05945875","Evaluating the Use of Dual Imaging Techniques for Detection of Disease in Patients With Head and Neck Cancer","Official Title Targeted Dual Modality Imaging (TDMI) for Detection and Removal of Head and Neck Cancer","Inclusion Criteria:\n\n* Age \\>= 19 years\n* Biopsy-confirmed diagnosis of squamous cell carcinoma of the head and neck\n* Subjects diagnosed with any T stage, any subsite within the head and neck that are scheduled to undergo surgical resection and neck dissection. Subjects with recurrent disease or a new primary will be allowed\n* Planned standard of care elective neck dissection for a cN0 or node- positive disease. Clinical node- positive disease will be defined as metastasis in a single, ipsilateral lymph node, 3 cm or less in greatest dimension by clinical exam, cross sectional imaging or metabolic imaging\n* Hemoglobin \\>= 9 gm\u002FdL\n* White blood cell count \\> 3000\u002Fmm\\^3\n* Platelet count \\>= 100,000\u002Fmm\\^3\n* Serum creatinine =\\\u003C 1.5 times upper reference range\n* Ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment\n* Evidence of QT prolongation on pretreatment electrocardiogram (ECG) (greater than 440 ms in males or greater than 450 ms in females)\n* History of infusion reactions to monoclonal antibody therapies\n* History of allergies to iodine\n* Pregnant or breastfeeding\n* Magnesium or potassium lower than the normal institutional values\n* Subjects receiving class IA (quinidine, procainamide) or class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents\n* Subjects with a history or evidence of interstitial pneumonitis or pulmonary fibrosis\n* Severe renal disease or anuria\n* Thyroid stimulating hormone (TSH) \\> 13 micro international units\u002FmL",{"count":48,"type":20},[50],"This phase I trial evaluates the safety and effectiveness of using two imaging techniques, indium In 111 panitumumab (111In-panitumumab) with single photon emission computed tomography (SPECT)\u002Fcomputed tomography (CT) and panitumumab-IRDye800 fluorescence imaging during surgery (intraoperative), to detect disease in patients with head and neck cancer. 111In-panitumumab is an imaging agent made of a monoclonal antibody that has been labeled with a radioactive molecule called indium In 111. The agent targets and binds to receptors on tumor cells. This allows the cells to be visualized and assessed with SPECT\u002FCT imaging techniques. SPECT is special type of CT scan in which a small amount of a radioactive drug is injected into a vein and a scanner is used to make detailed images of areas inside the body where the radioactive material is taken up by the cells. CT is an imaging technique for examining structures within the body by scanning them with x-rays and using a computer to construct a series of cross-sectional scans along a single axis. Panitumumab-IRDye800 is an imaging agent composed of panitumumab, a monoclonal antibody, linked to a fluorescent dye called IRDye800. Upon administration, panitumumab-IRDye800 targets and binds to receptors on tumor cells. This allows the tumor cells to be detected using fluorescence imaging during surgery. Adding 111In-panitumumab SPECT\u002FCT imaging to intraoperative panitumumab-IRDye800 fluorescence imaging may be more effective at detecting disease in patients with head and neck cancer.",[166,328],"2025-09-29",{"date":390,"type":32},"2025-10-03",{"date":150,"type":32},{"date":393,"type":20},"2028-12-31",{"name":38,"class":39},{"id":396,"slug":397,"hasResults":12,"nctId":398,"briefTitle":399,"officialTitle":400,"acronym":4,"eligibilityCriteria":401,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":402,"enrollmentInfo":403,"targetDuration":4,"studyType":305,"phases":4,"briefSummary":404,"conditions":405,"keywords":406,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":409,"lastUpdatePostDateStruct":410,"startDateStruct":412,"completionDateStruct":414,"leadSponsor":416,"locationsCount":417},"100125189","collecting-and-analyzing-tissue-samples-from-patients-undergoing-surgery-for-non-small-cell-lung-cancer-100125189","NCT00897117","Collecting and Analyzing Tissue Samples From Patients Undergoing Surgery for Non-Small Cell Lung Cancer","Molecular Fingerprinting of Lung Cancer","Inclusion criteria\n\n* Diagnosis of non-small cell lung cancer\n\n  * Clinical stage I and II disease\n  * Resectable disease and complete surgical resection planned\n* Treated on companion studies at Vanderbilt University, the Veterans Administration hospital, St. Thomas, and Vanderbilt-Ingram Cancer Center Affiliate Network\n* Tumor specimen samples must be available at resection\n\nExclusion criteria\n\n* Chemotherapy before surgery\n* Radiotherapy before surgery","120 Years",{"count":304,"type":20},"RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that may occur in RNA and identify biomarkers related to cancer.\n\nPURPOSE: This research study is collecting and analyzing lung tissue samples from patients undergoing surgery for non-small cell lung cancer.",[308],[407,408],"stage I non-small cell lung cancer","stage II non-small cell lung cancer","2025-09-22",{"date":411,"type":32},"2025-09-26",{"date":413,"type":4},"2001-05",{"date":415,"type":20},"2031-05-31",{"name":38,"class":39},3,{"id":419,"slug":420,"hasResults":12,"nctId":421,"briefTitle":422,"officialTitle":423,"acronym":424,"eligibilityCriteria":425,"healthyVolunteers":426,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":427,"targetDuration":4,"studyType":305,"phases":4,"briefSummary":429,"conditions":430,"keywords":4,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":432,"lastUpdatePostDateStruct":433,"startDateStruct":435,"completionDateStruct":437,"leadSponsor":439,"locationsCount":40},"100553197","cohort-to-augment-the-understanding-of-sarcoma-survivorship-across-the-lifespan-100553197","NCT06482957","Cohort to Augment the Understanding of Sarcoma Survivorship Across the Lifespan","CAUSAL: Cohort to Augment the Understanding of Sarcoma Survivorship Across the Lifespan","CAUSAL","Patients at any age with a history of sarcoma, with or without evidence of a persistent disease\n\n• For pediatric patients\n\n* Parent\u002Fprimary caregiver of patient\n* Sibling of patient aged 8 years or older",true,{"count":428,"type":20},2100,"This study evaluates the impact that a sarcoma diagnosis and treatment have had on patients over time.",[431],"Sarcoma","2025-09-15",{"date":434,"type":32},"2025-09-19",{"date":436,"type":32},"2022-04-01",{"date":438,"type":20},"2029-04",{"name":38,"class":39},{"id":441,"slug":442,"hasResults":12,"nctId":443,"briefTitle":444,"officialTitle":445,"acronym":446,"eligibilityCriteria":447,"healthyVolunteers":426,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":448,"targetDuration":4,"studyType":305,"phases":4,"briefSummary":450,"conditions":451,"keywords":4,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":432,"lastUpdatePostDateStruct":457,"startDateStruct":458,"completionDateStruct":460,"leadSponsor":462,"locationsCount":463},"100357342","studying-health-outcomes-after-treatment-in-patients-with-retinoblastoma-100357342","NCT03932786","Studying Health Outcomes After Treatment in Patients With Retinoblastoma","Research Into Visual Endpoints and RB Health Outcomes After Treatment (RIVERBOAT)","RIVERBOAT","* Unilateral or bilateral intraocular retinoblastoma\n* Diagnosis between the ages of 0 - 17.99 years\n* Diagnosis on or after January 1, 2008\n* No exclusions based on primary or secondary treatment modalities\n* Retrospective group patients must be ≥ 6 months post end of treatment at study entry\n\n  * For those already at this timepoint, they are now eligible\n  * For those in treatment, or otherwise not yet at this timepoint, they are eligible once at they are ≥ 6 months post end of treatment\n  * Prospective group patients must not have begun treatment\n* Patients with diminished capacity will not be enrolled.\n* Language: Patients must be able to communicate in English, French, or Spanish\n* Sibling Cohort: One sibling, not affected by retinoblastoma will be enrolled, preference for the sibling closest in age to the RB patient.\n* Regulatory Requirements: All patients and\u002For their parents or legal guardians must sign a written informed consent. All institutional, FDA, and NCI requirements for human studies must be met.",{"count":449,"type":20},900,"This trial studies health outcomes after treatment in patients with retinoblastoma. Gathering health information over time from patients and family members through vision assessments, samples of tissue and saliva, and questionnaires may help doctors learn more about what causes retinoblastoma, identify long-term health outcomes for patients with retinoblastoma, and find out which therapies may be the best for treating retinoblastoma",[452,453,454,455,456],"Retinoblastoma","Cancer Survivor","Biological Sibling","Intraocular Retinoblastoma","Unilateral Retinoblastoma",{"date":434,"type":32},{"date":459,"type":32},"2019-01-24",{"date":461,"type":20},"2031-01",{"name":38,"class":39},11,{"id":465,"slug":466,"hasResults":12,"nctId":467,"briefTitle":468,"officialTitle":469,"acronym":470,"eligibilityCriteria":471,"healthyVolunteers":426,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":472,"targetDuration":474,"studyType":305,"phases":4,"briefSummary":475,"conditions":476,"keywords":4,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":432,"lastUpdatePostDateStruct":477,"startDateStruct":479,"completionDateStruct":481,"leadSponsor":483,"locationsCount":40},"100303571","inherited-cancer-registry-100303571","NCT03231891","Inherited CAncer REgistry","Inherited CAncer REgistry (ICARE) Initiative","ICARE","Inclusion Criteria:\n\n* At least 18 years of age\n* Able and willing to provide informed consent",{"count":473,"type":20},10000,"100 Years","The purpose of the Inherited CAncer REgistry (ICARE) Initiative is to provide individuals interested in participating in studies focused on inherited cancer predisposition the opportunity to enroll in a research registry. Efforts through the registry include, but are not limited to, contribution of data to observational studies, targeted gene-specific studies, and education and outreach efforts for both participants and recruiting healthcare providers. Participants are given the opportunity to learn about and participate in other efforts for which they may be eligible.\n\nAll participants and recruiting healthcare providers receive educational newsletters twice per year which contain research and clinical updates in the field of cancer genetics. Providers who recruit patients can also access monthly web-based genetics case conferences which focus on different topics each month and are generally attended by a guest expert who provides background information on the topic as well as comments on the case presentations.\n\nParticipation in ICARE involves completion of an informed consent form, baseline questionnaire, follow-up questionnaires every two years, and medical record\u002Ftumor releases, as applicable. There is no cost to participate and all correspondence can be facilitated through phone, email, or mail.\n\nEnrollment can be completed either through a traditional paper-based consenting method (i.e. postal mail) or through the online enrollment option available on the ICARE website (InheritedCancer.net). If you are a patient interested in learning more or a provider interested in recruiting to ICARE, please visit our website where you may complete an online contact form requesting a study team member contact you.",[194],{"date":478,"type":32},"2025-09-16",{"date":480,"type":32},"2017-02-27",{"date":482,"type":20},"2035-12",{"name":38,"class":39},{"id":485,"slug":486,"hasResults":12,"nctId":487,"briefTitle":488,"officialTitle":4,"acronym":4,"eligibilityCriteria":489,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":490,"targetDuration":4,"studyType":305,"phases":4,"briefSummary":492,"conditions":493,"keywords":4,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":432,"lastUpdatePostDateStruct":495,"startDateStruct":496,"completionDateStruct":498,"leadSponsor":500,"locationsCount":40},"100148597","storage-and-research-use-of-human-bio-specimens-from-melanoma-patients-and-clinical-testing-for-assignment-of-treatment-100148597","NCT01205815","Storage and Research Use of Human Bio-specimens From Melanoma Patients and Clinical Testing for Assignment of Treatment","Inclusion criteria\n\n* Pathologically-proven diagnosis of melanoma.\n* Patient must have a test or procedure that has the potential to provide left-over tissue that can be banked for future research purposes OR the patient has already had a diagnostic or therapeutic procedure but who has not yet been approached to participate is also eligible.\n\nExclusion criteria\n\n* Any patient with significant contraindications to venipuncture (e.g., severe anemia) will be excluded from blood collection procedures. However, if the patient provides consent and a paraffin-embedded block or 10-15 unstained slides of their tissue diagnosis, they will not be excluded from this protocol.\n* Any patient unable or unwilling to provide consent.",{"count":491,"type":20},3000,"The purpose of this research is to identify biological characteristics occurring in the initiation and progression of melanoma.",[494],"Melanoma",{"date":434,"type":32},{"date":497,"type":32},"2010-06-03",{"date":499,"type":20},"2027-06",{"name":38,"class":39},{"id":502,"slug":503,"hasResults":12,"nctId":504,"briefTitle":505,"officialTitle":505,"acronym":4,"eligibilityCriteria":506,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":507,"targetDuration":4,"studyType":21,"phases":508,"briefSummary":509,"conditions":510,"keywords":4,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":515,"lastUpdatePostDateStruct":516,"startDateStruct":518,"completionDateStruct":520,"leadSponsor":522,"locationsCount":523},"100509874","phase-2-neoadjuvant-neratinib-in-stage-i-iii-her2-mutated-lobular-breast-cancers-100509874","NCT05919108","Neoadjuvant Neratinib in Stage I-III HER2-Mutated Lobular Breast Cancers","Inclusion Criteria:\n\nEach patient will be entered into this study only if all of these criteria are met:\n\n* Subjects aged 18 years or older at signing of informed consent.\n* New diagnosis of clinical stage I-III HR+ histologically-proven (i.e. absent or decreased e-cadherin expression) invasive lobular carcinoma\n* Synchronous breast tumors are permitted as long as the synchronous tumor is ER+ and HER2-negative.\n* ER+ disease defined as ≥1% estrogen receptor (ER) positive consistent with current American Society of Clinical Oncology\u002FCollege of American Pathologists (ASCO\u002FCAP) or European Society of Medical Oncology (ESMO) guidelines)\n* At the time of screening, histologically confirmed cancers in patients with previously documented activating HER2 mutation (see Appendix A) confirmed by a Clinical Laboratory Improvement Amendments (CLIA)-certified or equivalent laboratory.\n* Archival tissue availability (if not available a fresh tumor biopsy will be required) and subject must agree to submission of sample for central testing\n* Minimum tumor size of ≥1.5 cm by US, mammogram, MRI imaging, or clinical breast exam\n* ECOG performance status 0 or 1\n* Patients must have adequate hematologic, hepatic, and renal function. All laboratory tests must be obtained within 1 month of study entry. This includes:\n\n  * Estimated glomerular filtration rate of ≥50 mL\u002Fmin\n  * Albumin ≥ 2.5 g\u002FdL\n  * ANC ≥1500\u002Fmm\\^3\n  * Platelet count ≥100,000\u002Fmm\\^3\n  * HgB ≥ 9 g\u002FdL\n  * Total serum bilirubin ≤ 1.5 x ULN (in patients with known Gilbert Syndrome, a total bilirubin ≤ 3.0 x ULN, with direct bilirubin ≤ 1.5 x ULN)\n  * AST and ALT ≤ 3 x ULN\n* Pre-, peri-, or post-menopausal, confirmed by history or laboratory testing as needed\n* Diagnostic biopsy tissue availability with sufficient tumor to permit NGS (if not available, a fresh biopsy will be required)\n* No prior treatment for current diagnosis of breast cancer\n* For patients who are not postmenopausal (women) or surgically sterile (absence of ovaries and\u002For uterus or vasectomy), agreement to remain abstinent or to use two adequate methods of contraception (e.g., condoms, diaphragm, vasectomy\u002Fvasectomized partner, tubal ligation), during the treatment period and for at least 30 days after the last dose of study treatment. Hormone based oral contraceptives are not allowed on study. Postmenopausal is defined as:\n\n  * Age ≥ 55 years\n  * Age ≤ 55 years and amenorrheic for 12 months in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression; or follicle stimulating hormone and estradiol in the postmenopausal range. Female participants of childbearing potential are eligible to participate if they agree to use a highly effective method of contraception that has a low user dependency consistently and correctly.\n\nNote: The effects of neratinib on the developing fetus are unknown and endocrine therapy is contraindicated in pregnancy. For this reason and because teratogenic effects have been observed in nonclinical studies and neratinib, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of the study participation, and for 1 month after the last dose of study medication. Should a woman become pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation and 3.5 months after completion of study treatment.\n\nExclusion Criteria:\n\n* Evidence of distant metastatic disease\n* Synchronous breast cancer that is estrogen receptor negative OR HER2-amplified OR requires treatment with neoadjuvant chemotherapy per the judgement of the treating physician\n* Patients harboring ineligible somatic HER2 mutations, such as those that are subclonal in nature or those resulting in the expression of truncated proteins including alterations that result in premature stop codon or a change in reading frame (ie, frame shift mutations).\n* Prior endocrine therapy for breast cancer within the last 2 years\n* Women who are pregnant, are planning to become pregnant, or are breast-feeding\n* Any investigational treatment for the current diagnosis of breast cancer\n* HER2 amplification by FISH (HER2:CEP17 ratio \\>2.0) or IHC (HER2 (3+)\n* Hepatic function impairment as defined by AST or ALT \\> 3x ULN OR total serum bilirubin \\> 1.5 (in patients with known Gilbert syndrome, a total bilirubin of \\> 3.0 x ULN or direct bilirubin \\> 1.5 x ULN)\n* Significant chronic gastrointestinal disorder with diarrhea as a major symptom (eg, Crohn's disease, malabsorption, or Grade ≥2 National Cancer Institute \\[NCI\\] Common Terminology Criteria for Adverse Events Version 4.0 \\[CTCAE version 4.0\\] diarrhea of any etiology at baseline.\n* Evidence of significant medical illness, abnormal laboratory finding, or psychiatric illness\u002Fsocial situations that could, in the Investigator's judgment, make the patient inappropriate for this study.\n* Known hypersensitivity to any component of the investigational product, required combination therapy, or loperamide.\n* Unable or unwilling to swallow tablets.\n* Unable or unwilling to complete study procedures such as research biopsies or imaging\n* Any medical condition that in the judgement of the co-investigator would impair the patient's ability to complete the planned study therapy",{"count":221,"type":20},[23],"This phase II trial tests how well neratinib prior to the primary treatment (neoadjuvant) works in treating patients with stage I-III HER2 mutated lobular breast cancers. Neratinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of cancer cells. Giving neratinib in addition to normal therapy may work better in treating cancer than the endocrine therapy patients would normally receive.",[511,512,513,514],"Anatomic Stage I Breast Cancer","Anatomic Stage II Breast Cancer","Anatomic Stage III Breast Cancer","Invasive Breast Lobular Carcinoma","2025-09-08",{"date":517,"type":32},"2025-09-09",{"date":519,"type":32},"2024-05-30",{"date":521,"type":20},"2031-04-30",{"name":38,"class":39},5,{"id":525,"slug":526,"hasResults":12,"nctId":527,"briefTitle":528,"officialTitle":529,"acronym":4,"eligibilityCriteria":530,"healthyVolunteers":426,"sex":531,"minAge":18,"maxAge":4,"enrollmentInfo":532,"targetDuration":4,"studyType":305,"phases":4,"briefSummary":533,"conditions":534,"keywords":536,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":545,"lastUpdatePostDateStruct":546,"startDateStruct":547,"completionDateStruct":549,"leadSponsor":551,"locationsCount":40},"100125338","collecting-and-storing-tissue-samples-from-women-with-or-without-breast-cancer-100125338","NCT00899301","Collecting and Storing Tissue Samples From Women With or Without Breast Cancer","Breast Tissue\u002FBody Fluids Repository","* Breast lesion which is suspected to be cancer or a known diagnosis of breast cancer (any stage, at any point in the disease trajectory) who agrees to donate tissue\u002Fbody fluids.\n* Individuals of all races and ethnic groups are eligible for this trial. There is no restriction regarding age, race, or ethnicity. The trial is open to the accrual of men and women.\n* Must sign informed consent for study of tumor specimens as part of a research project.\n* Must give permission for their tumor specimens to be obtained from outside institutions for molecular analyses.\n* Must be willing to be followed for recurrence, relapse and death from disease.\n\nELIGIBILITY CRITERIA FOR OPTIONAL PHYSICAL FUNCTION AND COGNITIVE ASSESSMENTS\n\n* Must be 60 years of age or older\n* Have completed initial round of cancer treatment\n* Have completed the optional online survey and opted-in for the physical function and cognitive assessments","FEMALE",{"count":304,"type":20},"RATIONALE: Collecting and storing samples of tissue, blood, and urine from patients with or without breast cancer to study in the laboratory may help the study of cancer.\n\nPURPOSE: This research study is collecting and storing tissue samples from women with or without breast cancer.",[535],"Breast Cancer",[537,538,539,540,541,542,543,544],"breast cancer","stage IA breast cancer","stage IB breast cancer","stage II breast cancer","stage IIIA breast cancer","stage IIIB breast cancer","stage IIIC breast cancer","stage IV breast cancer","2025-08-26",{"date":210,"type":32},{"date":548,"type":32},"2004-01-22",{"date":550,"type":20},"2027-03",{"name":38,"class":39},{"id":553,"slug":554,"hasResults":12,"nctId":555,"briefTitle":556,"officialTitle":557,"acronym":4,"eligibilityCriteria":558,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":559,"targetDuration":4,"studyType":21,"phases":560,"briefSummary":561,"conditions":562,"keywords":564,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":566,"lastUpdatePostDateStruct":567,"startDateStruct":569,"completionDateStruct":571,"leadSponsor":572,"locationsCount":40},"100401343","phase-2-hypofractionated-radiotherapy-followed-by-surgical-resection-in-the-treatment-of-soft-tissue-sarcomas-100401343","NCT04506008","Hypofractionated Radiotherapy Followed by Surgical Resection in the Treatment of Soft Tissue Sarcomas","Prospective Observational Trial of Two Neoadjuvant Hypofractionated Radiotherapy Regimens Followed by Surgical Resection in the Treatment of Soft Tissue Sarcomas","Inclusion Criteria:\n\n* Histologic diagnosis of a soft tissue sarcoma of extremity, pelvis, chest wall or trunk\u002Fabdominal wall (non-retroperitoneal location)\n* ECOG performance status 0-2\n* Patient must be deemed able to comply with radiation treatment and surgery\n\nExclusion Criteria:\n\n* History of prior radiation to the same area to be irradiated\n* Pregnancy\n* Active collagen vascular disease or patients genetically predisposed to increased radiation related side effects",{"count":48,"type":20},[23],"The trial will use neoadjuvant hypofractionated radiotherapy followed by surgical resection in the treatment for soft tissue sarcoma. It will allow patients to be treated over a shorter course (5 or 15 days of radiation) compared to the traditional 5 week regimen. It is proposed that this will be possible without increasing the risk of wound complication or local recurrence compared with a traditional 5 week course of pre-operative radiation.",[563],"Soft Tissue Sarcomas",[565],"Hypofractionated Radiotherapy","2025-03-24",{"date":568,"type":32},"2025-03-28",{"date":570,"type":32},"2021-03-02",{"date":499,"type":20},{"name":38,"class":39},{"id":574,"slug":575,"hasResults":12,"nctId":576,"briefTitle":577,"officialTitle":578,"acronym":4,"eligibilityCriteria":579,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":580,"targetDuration":4,"studyType":305,"phases":4,"briefSummary":581,"conditions":582,"keywords":4,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":566,"lastUpdatePostDateStruct":588,"startDateStruct":589,"completionDateStruct":591,"leadSponsor":593,"locationsCount":40},"100262948","low-dose-total-skin-electron-therapy-in-treating-patients-with-refractory-or-relapsed-stage-ib-iiia-mycosis-fungoides-100262948","NCT02702310","Low-Dose Total Skin Electron Therapy in Treating Patients With Refractory or Relapsed Stage IB-IIIA Mycosis Fungoides","Prospective Observational Trial of Low-Dose Total Skin Electron Therapy in Mycosis Fungoides Using Rotisserie Technique","Inclusion Criteria:\n\n* Biopsy confirmed mycosis fungoides stage IB-IIIA\n* Skin manifestations of mycosis fungoides that are refractory to or have relapsed on at least one prior therapy, which may include topical steroids\n* Life expectancy \\> 6 months\n\nExclusion Criteria:\n\n* Serious medical condition that would make treatment unsafe\n* Pregnant or lactating patient",{"count":91,"type":20},"This clinical trial studies low- dose total skin electron therapy in treating patients with stage IB-IIIA mycosis fungoides that has not responded to previous treatment (refractory) or has returned after a period of improvement (relapsed). Radiation therapy uses high energy electrons to kill tumor cells and shrink tumors. Rotisserie technique is a method in which the patient receives total skin electron therapy while standing on a rotating platform. Giving low dose total skin electron therapy using rotisserie technique may kill tumor cells, while having fewer side effects, and may allow therapy to be repeated in future if clinically indicated.",[583,584,585,586,587],"Recurrent Mycosis Fungoides","Refractory Mycosis Fungoides","Stage I Mycosis Fungoides","Stage II Mycosis Fungoides","Stage III Mycosis Fungoides",{"date":568,"type":32},{"date":590,"type":32},"2016-05-22",{"date":592,"type":20},"2026-09",{"name":38,"class":39},{"id":595,"slug":596,"hasResults":12,"nctId":597,"briefTitle":598,"officialTitle":599,"acronym":600,"eligibilityCriteria":601,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":602,"targetDuration":604,"studyType":305,"phases":4,"briefSummary":605,"conditions":606,"keywords":4,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":608,"lastUpdatePostDateStruct":609,"startDateStruct":611,"completionDateStruct":613,"leadSponsor":615,"locationsCount":40},"100569974","the-clonal-hematopoiesis--inflammation-in-vasculature-registry-and-biorepository-100569974","NCT06701214","The Clonal Hematopoiesis & Inflammation in Vasculature Registry and Biorepository","Discovering Outcomes in Clonal Hematopoiesis: The Clonal Hematopoiesis and Inflammation in VasculaturE (CHIVE) Registry and Biorepository","CHIVE","Inclusion Criteria:\n\n* Patient greater than or equal to 18 years old at time of consent\n* Able to provide informed consent\n* Idiopathic cytopenia (ICUS) or idiopathic cytoses (elevated blood counts without disease or explanation); clonal cytopenia of undetermined significance (CCUS), clonal hematopoiesis of indeterminate potential (CHIP) or individuals at higher risk for clonal hematopoiesis (ex. patients with known diagnosis of solid tumors or cardiovascular disease)\n\nExclusion Criteria:\n\n* Unable to provide consent\n* Diagnosis of active hematologic malignancy. For example, a diagnosis of CMML, AML, MDS, MPN; History of hematologic malignancy is NOT exclusionary if in complete remission (e.g. previous myeloma or lymphoma)",{"count":603,"type":20},800,"10 Years","This study will investigate the association between clonal hematopoiesis and other conditions. Clonal hematopoiesis (CH) refers to the mutations in a person's stem cells which commonly affect people as they get older. These mutations have notably been linked to increased risk of certain cancers as well as increased risk of heart disease.",[607],"Clonal Hematopoiesis","2024-11-20",{"date":610,"type":32},"2024-11-22",{"date":612,"type":32},"2020-10-28",{"date":614,"type":20},"2031-11-30",{"name":38,"class":39},""]