[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"metastatic-sarcoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:metastatic-sarcoma":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,49,85,136,168,195,236,249,279,301],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100054031","targeted-oligometastatic-radiation-in-pediatric-and-young-adult-patients-with-soft-tissue-and-bone-sarcoma-100054031",false,"NCT06796543","Targeted Oligometastatic Radiation in Pediatric and Young Adult Patients With Soft Tissue and Bone Sarcoma","TARGET-RT","Stratum A Inclusion Criteria:\n\n* Patients must be aged \\\u003C 39 years at time of enrollment.\n* Patients must have a Karnofsky or Lansky performance score of 70 or greater or Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n* Patients must have newly diagnosed histologically or molecularly confirmed soft tissue or bone sarcoma at any site.\n* Patients must have metastatic disease that is measurable and this is defined as at least one lesion discontinuous from the primary that can be accurately measured in at least one dimension (longest diameter to be recorded) as \\> 3mm with CT scan within 3 weeks from treatment start.\n\nStratum B Inclusion Criteria:\n\n* Patients must have a Karnofsky or Lansky performance score of 70 or greater or ECOG performance status of 0-1.\n* Patients must have radiographic, histologic or molecular confirmation of progressive soft tissue or bone sarcoma at any site that was initially diagnosed at age \\\u003C 39 years. Progression includes progression at a new site or known sites of prior disease (e.g. recurrent).\n* Patients must have metastatic disease that is measurable and this is defined as at least one lesion discontinuous from the primary that can be accurately measured in at least one dimension (longest diameter to be recorded) as \\> 3mm with CT scan\n* Radiation to at least one site is being recommended as part of second line therapy.\n\nStratum A Exclusion Criteria:\n\n* Brain or intracranial metastases, including leptomeningeal disease\n* Clinical or radiologic evidence of spinal cord compression requiring emergent radiation treatment\n* Positive bone marrow biopsy for non-pelvic primary and greater than eight bone metastases. Presence of parenchymal lung metastases is considered as one metastasis, irrespective of how many lung nodules are present.\n* Evidence of any non-measurable metastatic disease including but not limited to leptomeningeal disease, malignant ascites and malignant pleural or pericardial effusions.\n* Pregnancy\n\nStratum B Exclusion Criteria:\n\n* Brain or intracranial metastases, including leptomeningeal disease\n* Clinical or radiologic evidence of spinal cord compression requiring emergent radiation treatment\n* Evidence of any non-measurable metastatic disease including but not limited to leptomeningeal disease, malignant ascites and malignant pleural or pericardial effusions.\n* Pregnancy","ALL","39 Years",{"count":19,"type":20},70,"ESTIMATED","INTERVENTIONAL",[23],"NA","This study is designed for children, adolescents and young adults undergoing radiation therapy for metastatic sarcoma. The aim of the study is to investigate if the investigators can improve the overall survival of these patients by targeting metastatic sites with radiation.",[26,27,28,29],"Metastatic Sarcoma","Radiation Therapy Patient","Ewing Sarcoma","Rhabdomyosarcoma",[31,26,32,29,33,34,35],"Pediatric","Ewing sarcoma","Brain tumor","Longitudinal","Radiation Therapy","RECRUITING","2026-07-10",{"date":39,"type":40},"2026-07-13","ACTUAL",{"date":42,"type":40},"2025-03-25",{"date":44,"type":20},"2030-03",{"name":46,"class":47},"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins","OTHER",3,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":56,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":21,"phases":59,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":84},"100493934","phase-1-testing-low-dose-common-chemotherapy-liposomal-doxorubicin-in-combination-with-an-anti-cancer-drug-peposertib-in-advanced-sarcoma-100493934","NCT05711615","Testing Low-Dose Common Chemotherapy (Liposomal Doxorubicin) in Combination With an Anti-Cancer Drug, Peposertib, in Advanced Sarcoma","A Phase 1 Study of Peposertib (M3814) and Low-Dose Liposomal Doxorubicin in Patients With Metastatic Leiomyosarcoma and Other Soft Tissue Sarcomas","Inclusion Criteria:\n\n* Patients must have histologically confirmed sarcoma that is metastatic or unresectable and for which there is no known curative treatment\n* Patients must have histologic diagnosis of leiomyosarcoma (LMS) or selected soft tissue sarcomas (myxofibrosarcoma \\[MFS\\], undifferentiated pleomorphic sarcoma \\[UPS\\], synovial sarcoma, or dedifferentiated liposarcoma \\[DDLPS\\]). Pathology review and confirmation of diagnosis will occur at the site enrolling the patient on this study. If the pathology has previously been reviewed by another site participating in the study, the diagnosis does not need to be re-reviewed at the enrolling site\n* Patients must have evaluable disease that is amenable to biopsy\n* Patients must have been treated with at least 1 prior line of therapy. Prior anthracycline use is permitted as long as the cumulative dose prior to enrollment does not exceed 360 mg\u002Fm\\^2\n* Age \\>= 18 years. Because no dosing or adverse event data are currently available on the use of peposertib (M3814) in combination with liposomal doxorubicin in patients \\\u003C 18 years of age, children are excluded from this study\n* Eastern Cooperative Oncology Group (ECOG) performance status =\\\u003C 2 (Karnofsky \\>= 60%)\n* Absolute neutrophil count \\>= 1,500\u002FmcL\n* Platelets \\>= 100,000\u002FmcL\n* Total bilirubin =\\\u003C 1.5 x institutional upper limit of normal (ULN)\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\\u003C 3 x institutional ULN\n* Hemoglobin \\>= 8 g\u002FdL\n* Glomerular filtration rate (GFR) \\>= 51 mL\u002Fmin\u002F1.73 m\\^2 (per institutional estimate based on creatinine level)\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression and clinical symptoms are stable while off steroid support\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* Patients with known history of clinically significant cardiac disease, or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better\n* Female patients of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n\n  * Female patients of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 3 months after the last dose of peposertib (M3814) and 6 months after the last dose of liposomal doxorubicin\n* Male patients of reproductive potential must agree to avoid impregnating a partner while receiving study drug and for 3 months after the last dose of peposertib (M3814) and 6 months after the last dose of liposomal doxorubicin by complying with adequate methods of contraception\n\n  * Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the patient\n* Ability to understand and the willingness to sign a written informed consent document. Participants with impaired decision-making capacity (IDMC) who have a legally-authorized representative (LAR) and\u002For family member available will also be eligible\n\nExclusion Criteria:\n\n* Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> grade 1) with the exception of alopecia\n* Prior palliative radiotherapy within 14 days of cycle 1 day 1 and prior definitive radiotherapy within 42 days of cycle 1 day 1. Adverse effects of radiation therapy must resolve to baseline prior to cycle 1 day 1\n* Patients who are receiving any other investigational agents\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to peposertib (M3814) or other agents used in study\n* Patients who cannot discontinue concomitant medications or herbal supplements that are strong inhibitors or strong inducers of cytochrome P450 (CYP) isoenzymes CYP3A4\u002F5, CYP2C9, and CYP2C19. Participants who cannot discontinue substrates with a narrow therapeutic index that are metabolized by CYP1A2, CYP2B6, CYP2C8, and CYP3A4\u002F5 are ineligible. Patients may confer with the study doctor to determine if alternative medications can be used. The following categories of medications and herbal supplements must be discontinued for at least the specified period of time before the patient can be treated:\n\n  * Strong inducers of CYP3A4\u002F5 and CYP2C19: \\>= 3 weeks prior to study treatment\n  * Strong inhibitors of CYP3A4\u002F5 and CYP2C19: \\>= 1 week prior to study treatment\n  * Substrates of CYP3A4\u002F5 with a narrow therapeutic index: \\>= 1 day prior to study treatment\n  * Strong inhibitors of CYP2C9: \\>= 1 week prior to study treatment\n* Patients who cannot discontinue concomitant proton-pump inhibitors (PPIs). Patients may confer with the study doctor to determine if such medications can be discontinued. These must be discontinued \\>= 5 days prior to study treatment. Patients do not need to discontinue calcium carbonate\n* Patients with left ventricular ejection fraction (LVEF) measurement below the institutional lower limit of normal (LLN) are excluded\n* Patients with uncontrolled intercurrent illness\n* Patients who cannot swallow tablets whole\n* Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are not eligible\n* Pregnant women are excluded from this study because peposertib (M3814) is an adenosine triphosphate (ATP)-competitive inhibitor of DNA-protein kinase catalytic subunit (PKcs) with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with peposertib (M3814), breastfeeding should be discontinued if the mother is treated with peposertib (M3814). These potential risks may also apply to other agents used in this study\n* Patients may not have received prior treatment with a DNA-protein kinase (PK) inhibitor","18 Years",{"count":58,"type":20},30,[60],"PHASE1","This phase I trial tests the safety, side effects, and best dose of combination therapy with liposomal doxorubicin and peposertib in treating patients with sarcoma that has spread from where it first started, to other places in the body (metastatic), or cannot be removed by surgery (unresectable) and for which no known cure is available (advanced). Doxorubicin is in a class of medications called anthracyclines. Doxorubicin damages the cell's deoxyribonucleic acid (DNA) and may kill cancer cells. It also blocks a certain enzyme needed for cell division and DNA repair. Liposomal doxorubicin is a form of the anticancer drug doxorubicin that is contained inside very tiny, fat-like particles. Liposomal doxorubicin may have fewer side effects and work better than other forms of the drug. Peposertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It may also enhance the activity of chemo- and radiotherapy. There is some pre-clinical evidence in animal models that combining peposertib with liposomal doxorubicin can shrink or stabilize certain types of cancer for longer than either drug alone, but it is not known if this will happen in people. Combination therapy with liposomal doxorubicin and peposertib may be effective in treating patients with advanced sarcoma.",[63,64,65,26,66,67,68,69,70,71,72,73],"Metastatic Dedifferentiated Liposarcoma","Metastatic Leiomyosarcoma","Metastatic Myxofibrosarcoma","Metastatic Synovial Sarcoma","Metastatic Undifferentiated Pleomorphic Sarcoma","Unresectable Dedifferentiated Liposarcoma","Unresectable Leiomyosarcoma","Unresectable Myxofibrosarcoma","Unresectable Sarcoma","Unresectable Synovial Sarcoma","Unresectable Undifferentiated Pleomorphic Sarcoma","2026-06-25",{"date":76,"type":40},"2026-06-26",{"date":78,"type":40},"2024-02-06",{"date":80,"type":20},"2026-11-03",{"name":82,"class":83},"National Cancer Institute (NCI)","NIH",16,{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":4,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":16,"minAge":56,"maxAge":4,"enrollmentInfo":92,"targetDuration":4,"studyType":21,"phases":94,"briefSummary":96,"conditions":97,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":135},"100421724","phase-2-avapritinib-for-the-treatment-of-ckit-or-pdgfra-mutation-positive-locally-advanced-or-metastatic-malignant-solid-tumors-100421724","NCT04771520","Avapritinib for the Treatment of CKIT or PDGFRA Mutation-Positive Locally Advanced or Metastatic Malignant Solid Tumors","Phase 2 Study of Avapritinib in Patients With CKIT or PDGFRA Mutation-Positive Malignant Solid Tumors","Inclusion Criteria:\n\n1. The patient (or legally acceptable representative if applicable) provides written informed consent for the study.\n2. Male or female ≥18 years of age on the day of informed consent signing. Adolescent patients aged 12 years and older are allowed with signed assent and parental consent according to institutional guidelines and requirements.\n3. Cohorts 1 and 2: Patient has a locally advanced or metastatic solid tumor and has progressed on appropriate standard therapy, has not shown clinically meaningful benefit to appropriate standard therapy, has no available standard therapy, or has declined appropriate standard therapy.\n\n   • NOTE: Specific solid tumor types include but are not limited to melanoma, breast cancer, lung cancer, gastroesophageal cancer, colorectal cancer, sarcoma, solid tumors NOS, and primary CNS tumors. Patients with any other recurrent solid tumor type with the exception of gastrointestinal stromal tumor (GIST) will be eligible.\n4. Cohort 3: Patient has newly diagnosed IDH wild-type, MGMT-unmethylated glioblastoma. Patients must have received prior treatment with radiation and concurrent temozolomide per standard of care.27 Patients must have completed radiation and concurrent temozolomide 3-8 weeks prior to study treatment initiation.\n5. Measurable disease per the RECIST v1.1 or RANO criteria, as appropriate, for Cohorts 1 and 2. Patients in Cohort 3 can have measurable or non-measurable disease per the RANO criteria.\n\n6 Documented pathogenic CKIT activating mutation (Cohort 1) OR pathogenic PDGFRA activating mutation (Cohort 2) based on Clinical Laboratory Improvement Amendments-certified next-generation sequencing diagnostic test. Cohort 3 should have pathogenic CKIT or PDGFRA activating mutation\u002Famplification based on CLIA-certified NGS diagnostic test. CKIT and PDGFRA mutation pathogenicity will be verified by the MD Anderson Cancer Center's Precision Oncology Decision Support team. Acceptable CKIT\u002FPDGFRA mutations for study eligibility are listed in Appendix E.\n\n7\\. Has available archival tissue for CKIT\u002FPDGFRA mutation (amplification \\[Cohort 3 only\\]) retrospective testing.\n\n8\\. Adequate organ and marrow function as defined below within 7 days of study treatment initiation:\n\n* White blood cell count \\>2,500\u002FµL and \\\u003C15,000\u002FµL\n* Absolute neutrophil count ≥1.5 × 109\u002FL (without granulocyte colony-stimulating factor support within 2 weeks of laboratory test used to determine eligibility)\n* Platelet count ≥75 × 109\u002FL (without transfusion within 2 weeks of laboratory test used to determine eligibility)\n* Hemoglobin ≥9.0 g\u002FdL (without blood transfusion within 7 days of laboratory test used to determine eligibility)\n* Total bilirubin ≤1.5 × upper limit of normal (ULN); if hepatic metastases are present, ≤3.0 × ULN\n* Aspartate transaminase and alanine transaminase ≤2.5 × ULN; if hepatic metastases are present, ≤5.0 × ULN\n* Serum creatinine ≤2.0 × ULN or creatinine clearance ≥45 mL\u002Fmin. 9. Cardiac ejection fraction \\>45% per screening echocardiogram or multigated acquisition scan.\n\n  10\\. Eastern Cooperative Oncology Group performance status of 0-2.\n\n  11\\. Life expectancy ≥3 months.\n\n  12\\. Willing and able to comply with the protocol for the duration of the study including treatment and scheduled visits and examinations.\n\n  13\\. Willing to undergo biopsy as required by the study.\n\n  14\\. Females must be postmenopausal (defined as ≥45 years of age with at least 12 months of spontaneous amenorrhea) or premenopausal with documented surgical sterilization (tubal ligation, hysterectomy, bilateral salpingectomy, or bilateral oophorectomy), or evidence of non-childbearing status for women of childbearing potential (negative serum beta-human chorionic gonadotropin pregnancy test) within 3 days of study treatment initiation.\n\n  15\\. Females of childbearing potential must either abstain from heterosexual intercourse or use a highly effective method of contraception for the course of the study and for 6 weeks after the last dose of study treatment.\n\n  16\\. Males with female partners of reproductive potential must either abstain from sexual intercourse or they and their partners must use a highly effective method of contraception when engaging in sexual intercourse for the course of the study through 30 days after the last dose of study treatment.\n\nExclusion Criteria:\n\nPatients eligible for this study must not meet any of the following criteria:\n\n1. Patients who have GIST.\n2. Patients with tyrosine kinase inhibitor-resistant CKIT mutation V654A or T670I.\n3. Patients with meningeal carcinomatosis, leptomeningeal carcinomatosis, spinal cord compression, or symptomatic or unstable brain metastases. Note: Patients with stable brain metastases (defined as asymptomatic or no requirement for high-dose or increasing dose of systemic corticosteroids) and without imminent need of radiation therapy) are eligible (including those with untreated brain metastases). If applicable, patients must have completed brain radiation therapy and recovered adequately from any associated toxicity and\u002For complications prior to eligibility assessment. For patients who have received prior radiation therapy, post-treatment magnetic resonance imaging scan should show no increase in brain lesion size\u002Fvolume.\n4. History of documented congestive heart failure (New York Heart Association functional classification III-IV) or serious cardiac arrhythmias requiring treatment.\n5. QT interval corrected using Fridericia's formula of \\>470 msec.\n6. Is currently participating or has participated in a study of an investigational agent or has used an investigational device within 2 weeks prior to study treatment initiation.\n7. Prior anticancer chemotherapy, hormone therapy, immunotherapy, targeted therapy, radiation therapy, or surgery within 2 weeks prior to study treatment initiation.\n\n   * NOTE: Patients must have recovered from all AEs due to previous therapies to ≤ Grade 1 or baseline (except alopecia). Patients with ≤ Grade 2 neuropathy are eligible.\n   * NOTE: If patient received major surgery, she\u002Fhe must have recovered adequately from the toxicity and\u002For complications from the intervention prior to study treatment initiation.\n   * NOTE: Patients in Cohort 3 must have completed radiation and concurrent temozolomide 3-8 weeks prior to study treatment initiation.\n8. Symptomatic non-healing wound, ulcer, gastrointestinal perforation, or bone fracture.\n9. History of psychotic or depressive disorder. Patients whose disorder is well controlled on a stable antipsychotic or antidepressant medication for at least 12 months prior to study entry will be eligible.\n10. Concomitant use of a known strong cytochrome P450 (CYP)3A4 inhibitor or strong CYP3A4 inducer. The required washout period prior to study treatment initiation is 2 weeks or 5 half-lives, whichever is shortest.\n11. Females who are pregnant or breastfeeding.\n12. Unable to swallow and retain oral medications.\n13. Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of the study treatment (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).\n14. Known additional malignancy that is progressing or requires active treatment. NOTE: Patients with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or cervical cancer in situ that have undergone potentially curative therapy are not excluded.\n15. History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the investigator.\n16. Prior treatment with an intracerebral agent or bevacizumab (Cohort 3 only).\n17. Prior treatment including radiation, chemotherapy, or immunotherapy for low-grade glioma (Cohort 3 only).",{"count":93,"type":20},50,[95],"PHASE2","This phase II trial studies the effect of avapritinib in treating malignant solid tumors that have a genetic change (mutation) in CKIT or PDGFRA and have spread to nearby tissue or lymph nodes (locally advanced) or other places in the body (metastatic). Avapritinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Avapritinib may help to control the growth of malignant solid tumors.",[98,99,100,101,102,103,104,105,106,107,108,26,109,110,111,112,113,114,115,116,117,118,119,120,121,122,123,124,125],"Anatomic Stage IV Breast Cancer AJCC v8","Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8","Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8","Clinical Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8","Locally Advanced Malignant Solid Neoplasm","Locally Advanced Melanoma","Locally Advanced Primary Malignant Central Nervous System Neoplasm","Locally Advanced Sarcoma","Metastatic Malignant Solid Neoplasm","Metastatic Melanoma","Metastatic Primary Malignant Central Nervous System Neoplasm","Pathologic Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8","Pathologic Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8","Pathologic Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8","Postneoadjuvant Therapy Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8","Postneoadjuvant Therapy Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8","Postneoadjuvant Therapy Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8","Prognostic Stage IIIC Breast Cancer AJCC v8","Prognostic Stage IV Breast Cancer AJCC v8","Stage IIIC Colorectal Cancer AJCC v8","Stage IIIC Lung Cancer AJCC v8","Stage IV Colorectal Cancer AJCC v8","Stage IV Lung Cancer AJCC v8","Stage IVA Colorectal Cancer AJCC v8","Stage IVA Lung Cancer AJCC v8","Stage IVB Colorectal Cancer AJCC v8","Stage IVB Lung Cancer AJCC v8","Stage IVC Colorectal Cancer AJCC v8","2026-06-09",{"date":128,"type":40},"2026-06-11",{"date":130,"type":40},"2021-01-20",{"date":132,"type":20},"2026-12-31",{"name":134,"class":47},"M.D. Anderson Cancer Center",1,{"id":137,"slug":138,"hasResults":11,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":142,"eligibilityCriteria":143,"healthyVolunteers":11,"sex":16,"minAge":56,"maxAge":4,"enrollmentInfo":144,"targetDuration":4,"studyType":21,"phases":146,"briefSummary":147,"conditions":148,"keywords":150,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":167},"100643192","study-of-the-impact-of-digital-health-interventions-on-symptom--side-effect-management-in-metastatic-sarcoma-patients-100643192","NCT07642375","Study of the Impact of Digital Health Interventions on Symptom & Side-Effect Management in Metastatic Sarcoma Patients","Observational, Randomized, Prospective Study of the Impact of Digital Health Interventions on Symptom and Side-Effect Management in Patients With Metastatic Sarcoma","SARC-Digital","Inclusion Criteria:\n\n* Age of ≥ 18 years.\n* Diagnosis of locally advanced or metastatic sarcoma of any location and origin.\n* Ability to understand and operate in a digital environment.\n* Patients planned to start standard of care treatment within the next month, or are currently undergoing standard of care treatment of any line.\n* Treatments include surgery, radiotherapy, chemotherapy, immunotherapy, targeted therapy, hormonal therapy, or any combination of the above.\n\nExclusion Criteria:\n\n* Limited ability or willingness to report side-effects on an online platform.\n* Performance status \\>3.\n* Life expectancy of \\\u003C6 months.\n* Participation in an interventional clinical trial with investigational drugs or devices.",{"count":145,"type":20},108,[23],"The objective of this prospective study is to capture the quality of life of patients with locally advanced or metastatic sarcoma, and investigate the effectiveness of support provided through a personalized web-based platform.",[149,26],"Advanced Sarcoma",[151,152,153,154,155,156,157],"digital oncology","quality of life","qol","patient reported outcomes","PRO","supportive care","digital therapeutics","2026-06-07",{"date":128,"type":40},{"date":161,"type":40},"2023-08-22",{"date":163,"type":20},"2027-02",{"name":165,"class":166},"CareAcross","INDUSTRY",11,{"id":169,"slug":170,"hasResults":11,"nctId":171,"briefTitle":172,"officialTitle":173,"acronym":174,"eligibilityCriteria":175,"healthyVolunteers":11,"sex":16,"minAge":176,"maxAge":177,"enrollmentInfo":178,"targetDuration":4,"studyType":21,"phases":179,"briefSummary":180,"conditions":181,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":135},"100534153","phase-1-safety-and-feasibility-of-intraoperative-visualization-with-cytalux-in-children-100534153","NCT06235125","Safety and Feasibility of Intraoperative Visualization With Cytalux in Children","A Pilot Study of Near-Infrared Imaging Using the Novel Imaging Agent Cytalux for Adolescent Patients With Metastatic Osteosarcoma Undergoing Pulmonary Metastasectomy","Cytalux","Inclusion Criteria:\n\n1. Patients 6-17 years of age at the time of study enrollment\n2. Willingness of research participant or legal guardian\u002Frepresentative to give written informed consent\n3. Willingness of patients (subjects) age 12-17 to provide written adolescent assent\n4. Patient weight greater than or equal to 20 kg\n5. Histologically confirmed diagnosis of osteosarcoma, synovial sarcoma, hepatoblastoma, rhabdomyosarcoma, Ewing sarcoma, Wilms tumor or other non-rhabdomyosarcoma soft tissue sarcoma\n6. Imaging findings highly suspicious for pulmonary metastatic disease based on CT, PET-CT or other imaging and warranting pulmonary surgery based on the judgment of the treating team. At least one nodule ≥4mm measured by preoperative imaging.\n7. Female (assigned female at birth) participant is not pregnant and agrees to an acceptable form of contraception from the time of consent through 30 days after study intervention. Confirmed abstinence is an acceptable form of contraception.\n8. Female (assigned female at birth) participant must agree to not donate ova from time of consent until 30 days after study intervention\n9. Male (assigned male at birth) participant must agree to not donate sperm from time of consent until 30 days after study intervention.\n\nExclusion Criteria:\n\n1. Any medical condition that in the opinion of the investigators could potentially jeopardize the safety of the subject\n2. History of anaphylactic reactions to products containing indocyanine green for near infrared imaging. Subjects with a medical history of 'idiopathic anaphylaxis' will also be excluded.\n3. History of allergy to any of the components of CYTALUX™ (PAFOLACIANINE) INJECTION\n4. Presence of any psychological, familial, sociological condition or geographical challenges potentially hampering compliance with the study protocol or follow-up schedule\n5. Impaired renal function defined as eGFR\\\u003C 50 mL\u002Fmin\u002F1.73m2\n6. Impaired liver function defined as values \\> 3x the upper limit of normal (ULN) for alanine aminotransferase (ALT) or aspartate aminotransferase (AST), alkaline phosphatase (ALP), or \\>2x ULN for total bilirubin except in subjects with Gilbert's syndrome.\n7. Patient unable or unwilling to discontinue folate, folic acid, or folate-containing supplements 48 hours before study drug administration\n8. History of drug-related serious adverse event with prior Cytalux administration will be an exclusion for re-enrollment for contralateral surgery (see section 5.7).\n9. Participants will be excluded if their 12th or 18th birthday would occur during study participation\n10. Male sex at birth and commitment to acceptable form of contraception from time of consent through 30 days after study intervention with confirmed abstinence as an acceptable form of contraception as an inclusion criterion.","6 Years","17 Years",{"count":5,"type":20},[60],"Pediatric subjects aged 6-17 with biopsy confirmed cancer and imaging findings suspicious for pulmonary metastatic disease scheduled to undergo pulmonary metastasectomy via and open or minimally invasive approach.",[182,183,184,26,185],"Osteosarcoma","Pulmonary Metastasis","Fluorescence","Pediatrics","2026-06-03",{"date":188,"type":40},"2026-06-05",{"date":190,"type":40},"2024-04-08",{"date":192,"type":20},"2026-08-31",{"name":194,"class":47},"Ann & Robert H Lurie Children's Hospital of Chicago",{"id":196,"slug":197,"hasResults":11,"nctId":198,"briefTitle":199,"officialTitle":200,"acronym":4,"eligibilityCriteria":201,"healthyVolunteers":11,"sex":16,"minAge":56,"maxAge":4,"enrollmentInfo":202,"targetDuration":4,"studyType":21,"phases":204,"briefSummary":205,"conditions":206,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":228,"startDateStruct":230,"completionDateStruct":232,"leadSponsor":234,"locationsCount":135},"100348926","intravital-microscopy-in-human-solid-tumors-100348926","NCT03823144","Intravital Microscopy in Human Solid Tumors","Intravital Microscopy (IVM) in Human Solid Tumors","Inclusion Criteria:\n\n* Age ≥ 18 years of age\n* Eastern Cooperative Oncology Group (ECOG)Performance Status of ≤ 2\n* Measurable tumor by direct visualization requiring surgical resection in the operating room (OR)\n* Tumor types of origin include gastric, pancreatic, hepatobiliary, colorectal, sarcoma, brain, or breast cancer that may involve the axillary lymph nodes cancers. Tumors may be primary or metastatic\n* Subject must understand the investigational nature of this study and sign an Independent Ethics Committee\u002FInstitutional Review Board approved written informed consent\n* Subject must have a skin prick test pre-operatively (at the time of the preoperative visit and after signed informed consent for entry into this clinical trial is given) to determine any sensitivity to fluorescein\n\nExclusion Criteria:\n\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations\n* Renal dysfunction as defined as a glomerular filtration rate (GFR) \\\u003C 45\n* Liver dysfunction as defined by Child-Pugh score \\> 5, or liver function test (LFT)'s 1.5 x above normal range\n* Any known allergy or prior reaction to fluorescein or a positive skin prick test to fluorescein\n* Pregnant or nursing female subjects, determined preoperatively with a urine pregnancy test\n* Unwilling or unable to follow protocol requirements\n* Any condition which in the investigators' opinion deems the patient unsuitable (e.g., abnormal electrocardiography \\[EKG\\], including T wave inversion, elevated T waves, prolonged QRS interval, or conduction blocks) or that requires further work-up (including cardiac echo or stress test)\n* Any condition that excludes surgical resection as the standard of care for the patient",{"count":203,"type":20},85,[23],"This study will investigate the tumor-associated vasculature of patients with solid tumors. The investigators will use a technology known as intravital microscopy (IVM) in order to visualize in real-time the vessels associated with solid tumors. The IVM observations may determine if an individual patient's tumor vessels would be amenable to receiving systemic therapy, based on the functionality of the vessels.",[207,208,209,210,211,212,26,213,214,215,216,217,119,98,218,219,220,221,222,223,224,225,226],"Solid Tumor, Adult","Clinical Stage IV Gastric Cancer AJCC v8","Malignant Solid Neoplasm","Metastatic Colorectal Carcinoma","Metastatic Gastric Carcinoma","Metastatic Primary Malignant Brain Neoplasm","Postneoadjuvant Therapy Stage IV Gastric Cancer AJCC v8","Resectable Colorectal Carcinoma","Resectable Liver and Intrahepatic Bile Duct Carcinoma","Resectable Pancreatic Carcinoma","Resectable Sarcoma","Malignant Brain Neoplasm","Metastatic Breast Carcinoma","Metastatic Liver Carcinoma","Metastatic Pancreatic Carcinoma","Resectable Brain Neoplasm","Resectable Breast Carcinoma","Resectable Gastric Carcinoma","Stage IV Hepatocellular Carcinoma AJCC v8","Stage IV Pancreatic Cancer AJCC v8","2026-05-29",{"date":229,"type":40},"2026-06-02",{"date":231,"type":40},"2019-02-28",{"date":233,"type":20},"2027-09-30",{"name":235,"class":47},"Mayo Clinic",{"id":237,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":17,"enrollmentInfo":238,"targetDuration":4,"studyType":21,"phases":239,"briefSummary":24,"conditions":240,"keywords":241,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":242,"lastUpdatePostDateStruct":243,"startDateStruct":245,"completionDateStruct":246,"leadSponsor":247,"locationsCount":248},"100577303",{"count":19,"type":20},[23],[26,27,28,29],[31,26,32,29,33,34,35],"2026-04-17",{"date":244,"type":40},"2026-04-20",{"date":42,"type":40},{"date":44,"type":20},{"name":46,"class":47},2,{"id":250,"slug":251,"hasResults":11,"nctId":252,"briefTitle":253,"officialTitle":254,"acronym":4,"eligibilityCriteria":255,"healthyVolunteers":11,"sex":16,"minAge":56,"maxAge":4,"enrollmentInfo":256,"targetDuration":4,"studyType":21,"phases":258,"briefSummary":259,"conditions":260,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":271,"lastUpdatePostDateStruct":272,"startDateStruct":274,"completionDateStruct":276,"leadSponsor":278,"locationsCount":135},"100415725","cryoablation-combined-with-stereotactic-body-radiation-therapy-for-the-treatment-of-painful-bone-metastases-the-crome-trial-100415725","NCT04693377","Cryoablation Combined With Stereotactic Body Radiation Therapy for the Treatment of Painful Bone Metastases, the CROME Trial","Cryoablation Combined With Stereotactic Body Radiation Therapy for the Treatment of Painful Bone Metastases","Inclusion Criteria:\n\n* Patient must have a primary diagnosis of malignancy and radiographic evidence of bone metastases. Eligible tumor histologies include the following malignancies with low alpha\u002Fbeta ratios: renal cell carcinoma, urothelial carcinomas, castration-resistant prostate cancer, sarcoma, thyroid carcinoma, colorectal carcinoma, and melanoma\n* A target lesion the meets the following criteria:\n\n  * The target lesion must be amenable to both cryoablation and SBRT, as determined by the study principal investigators (PIs)\n  * The target lesion must be =\\\u003C 7cm\n  * The pain due to the target lesion must be at least 4\u002F10 based on the BPI pain scale\n  * Pain from the metastatic site must correlate with an identifiable tumor on computed tomography (CT), magnetic resonance imaging (MRI), or ultrasound (US) imaging\n* Life expectancy \\>= 3 months\n* Platelet count \\> 50,000\u002Fmm\\^3 within 6 weeks of screening\n* International normalized ratio (INR) \\\u003C 1.5 within 6 weeks of screening\n* If taking antiplatelet or anticoagulation medication, it must be able to be discontinued 48 hours prior to the procedure or at the discretion of the PI (e.g., aspirin, ibuprofen, low molecular weight heparin \\[LMWH\\] preparations)\n* Eastern Cooperative Oncology Group (ECOG) performance status =\\\u003C 1 (Karnofsky \\>= 70%) within 6 weeks of screening\n* Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply: Women \\\u003C 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization. Women \\>= 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses \\> 1 year ago, had chemotherapy-induced menopause with last menses \\> 1 year ago, or underwent surgical sterilization\n* All lines of prior systemic therapy are permissible. Standard concurrent chemotherapy, immunotherapy, or targeted therapy are permissible\n* Ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Prior locoregional therapy to target lesion, including ablation of any modality, embolization, radiation, or surgery\n* Patient may not be receiving any other investigational agents. Standard concurrent chemotherapy, immunotherapy, or targeted therapy will be allowed\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, interstitial lung disease, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Pregnant or nursing women; women of childbearing potential unless using effective contraception as determined by the investigator\n* Target lesions that involve the spinal column or calvarium\n* Absolute neutrophil count \\\u003C 1000 mm\\^3 within 6 weeks of screening\n* Active infection\n* Presence of confirmed pathologic fracture at the target lesion not amenable to percutaneous stabilization\n* Lesions that involve a weight-bearing long bone of the lower extremity with the tumor causing \\> 50% loss of cortical bone. Lesions involving the hands and feet",{"count":257,"type":20},40,[23],"This trial compares cryoablation combined with stereotactic body radiation therapy to stereotactic body radiation therapy alone to see how well they work in treating patients with pain from cancer that has spread to the bones (bone metastases). Bone is a common site of metastasis in advanced cancer, and bone metastases often result in debilitating cancer-related pain. The current standard of care to treat painful bone metastases is radiation therapy alone. However, many patients do not get adequate pain relief from radiation therapy alone. Another type of therapy that may be used to provide pain relief from bone metastases is cryoablation. Cryoablation is a procedure in which special needles are inserted into the tumor site. These needles grow ice balls at their tips to freeze and kill cancer cells. The goal of this trial is to compare how well cryoablation in combination with radiation therapy works to radiation therapy alone when given to cancer patients to provide pain relief from bone metastases.",[261,210,262,106,107,263,264,26,265,266,119,267,268,121,269,123,270,125],"Castration-Resistant Prostate Carcinoma","Metastatic Malignant Neoplasm in the Bone","Metastatic Prostate Carcinoma","Metastatic Renal Cell Carcinoma","Metastatic Thyroid Gland Carcinoma","Metastatic Urothelial Carcinoma","Stage IV Prostate Cancer AJCC v8","Stage IV Renal Cell Cancer AJCC v8","Stage IVA Prostate Cancer AJCC v8","Stage IVB Prostate Cancer AJCC v8","2026-04-10",{"date":273,"type":40},"2026-04-15",{"date":275,"type":40},"2021-03-16",{"date":277,"type":20},"2027-04-01",{"name":134,"class":47},{"id":280,"slug":281,"hasResults":11,"nctId":282,"briefTitle":283,"officialTitle":284,"acronym":4,"eligibilityCriteria":285,"healthyVolunteers":11,"sex":16,"minAge":286,"maxAge":4,"enrollmentInfo":287,"targetDuration":4,"studyType":21,"phases":289,"briefSummary":290,"conditions":291,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":293,"lastUpdatePostDateStruct":294,"startDateStruct":296,"completionDateStruct":298,"leadSponsor":300,"locationsCount":135},"100377783","implantable-microdevice-for-the-delivery-of-drugs-and-their-effect-on-tumors-in-patients-with-metastatic-or-recurrent-sarcoma-100377783","NCT04199026","Implantable Microdevice for the Delivery of Drugs and Their Effect on Tumors in Patients With Metastatic or Recurrent Sarcoma","Pilot Trial of an Implantable Microdevice for In Vivo Drug Sensitivity Testing in Patients With Sarcomas","Inclusion:\n\n* Patients with a biopsy-confirmed recurrent or metastatic sarcoma for which surgery is indicated as a standard of care.\n* 10 years of age or older\n* Documented, signed, dated informed consent to participate in the microdevice study\n* Eastern Cooperative Oncology Group (ECOG) performance status of =\\\u003C 2\n\nExclusion:\n\n* Subjects who do not wish to undergo surgical resection, or those who are high-risk or not candidates for surgical resection\n* Age \\\u003C 10 years old\n* Women of childbearing potential without a negative pregnancy test; or women who are lactating\n* Allergies or prior adverse drug reactions to any of the drugs loaded within the microdevice.","10 Years",{"count":288,"type":20},20,[23],"This early phase I trial studies the side effects of implanting and removing a microdevice in patients with sarcomas that have spread to other places in the body (metastatic) or have come back (recurrent). Microdevices are rice-sized devices that are implanted into tumor tissue and are loaded with 10 different drugs that are delivered at very small doses, or \"microdoses,\" which may only affect a very small, local area inside the tumor. The purpose of this study is to determine which drugs delivered in the microdevice affect tumor tissue in patients with sarcomas.",[26,292,217],"Recurrent Sarcoma","2026-02-17",{"date":295,"type":40},"2026-02-19",{"date":297,"type":40},"2025-02-25",{"date":299,"type":20},"2028-12-31",{"name":134,"class":47},{"id":302,"slug":303,"hasResults":11,"nctId":304,"briefTitle":305,"officialTitle":306,"acronym":307,"eligibilityCriteria":308,"healthyVolunteers":11,"sex":16,"minAge":309,"maxAge":4,"enrollmentInfo":310,"targetDuration":4,"studyType":21,"phases":312,"briefSummary":313,"conditions":314,"keywords":320,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":324,"lastUpdatePostDateStruct":325,"startDateStruct":327,"completionDateStruct":329,"leadSponsor":331,"locationsCount":333},"100539059","phase-1-64cu-lnth-1363s-in-patients-with-sarcoma-or-gastrointestinal-tract-cancer-100539059","NCT06298916","64Cu-LNTH-1363S in Patients With Sarcoma or Gastrointestinal Tract Cancer","A Phase 1\u002F2a Study Utilizing 64Cu-LNTH-1363S (64Cu Radiolabeled FAPi PET\u002FCT Imaging Agent) in Patients With Sarcoma or Gastrointestinal Tract Cancer (PHANTOM Trial)","PHANTOM","Inclusion Criteria: Part 1\n\nPatients are eligible to be included in the study only if all of the following criteria apply:\n\n1. Patient must be ≥ 15 years of age and must have provided written informed consent and assent, where applicable (by patient or legal guardian). Those aged ≥15 to \\\u003C18 years must weigh at least 55 kg.\n2. Patients with suspected FAP-expressing metastatic sarcoma.\n3. Patients must have histological, pathological, and\u002For cytological confirmation of a metastatic sarcoma (e.g., undifferentiated pleomorphic sarcoma, liposarcoma, Leiomyosarcoma, myxofibrosarcoma, solitary fibrous tumor, Ewing's sarcoma, synovial sarcoma, sarcoma not otherwise specified, osteosarcoma).\n4. Patients must be willing to consent to provide sufficient and adequate archived tumor tissue samples (formalin fixed, paraffin embedded sample), preferably from a biopsy of a tumor lesion obtained either at the time of or after the diagnosis of disease; if archival tissue sample is unavailable, a new biopsy should be performed on the most accessible lesion(s) to obtain the tumor tissue sample.\n5. Adequate renal function as determined by a calculated creatinine clearance ≥ 60 mL\u002Fmin (Cockcroft Gault equation).\n6. Women of childbearing potential (WOCBP) must have a negative beta-human chorionic gonadotropin (β-hCG) test and must not be breastfeeding. WOCBP must agree to use a highly effective method of contraception during the study and for 28 days after the last injection of the study drug.\n7. Male subjects who are able to father a child must agree to avoid impregnating a partner, to adhere to a highly effective method of contraception and to not donate sperm during the study and for 28 days after the last injection of the study drug.\n\nInclusion Criteria: Part 2\n\n1. Patient must be ≥ 15 years of age and must have provided written informed consent and assent, where applicable (by patient or legal guardian). Those aged ≥15 to \\\u003C18 years must weigh at least 55 kg.\n2. Patients must have histological, pathological, and\u002For cytological confirmation of a sarcoma or GIT cancers e.g., esophageal, gastric, pancreatic, colorectal cancer.\n3. Patients must have suspected FAP expressing sarcoma or GIT cancers and planned for surgery within 60 days (from study imaging).\n4. Patients must be willing to consent to provide sufficient and adequate tumor tissue samples (formalin fixed, paraffin embedded sample), from their planned surgery after participating in study imaging.\n5. Adequate renal function as determined by a calculated creatinine clearance ≥ 60 mL\u002Fmin (Cockcroft Gault equation).\n6. Women of childbearing potential (WOCBP) must have a negative beta-human chorionic gonadotropin (β-hCG) test and must not be breastfeeding. WOCBP must agree to use a highly effective method of contraception during the study and for 28 days after the last injection of the study drug.\n7. Male subjects who are able to father a child must agree to avoid impregnating a partner, to adhere to a highly effective method of contraception and to not donate sperm during the study and for 28 days after the last injection of the study drug.\n\nExclusion Criteria: Part 1\n\nPatients are excluded from the study if any of the following criteria apply:\n\n1. Unlikely to comply with protocol procedures, restrictions and requirements as judged by the Investigator.\n2. Known pregnancy or breastfeeding.\n3. Any PET scan done within 10 physical half-lives of the PET agent prior to receiving study intervention.\n4. Patients participating in another clinical trial at the time of screening for this study.\n5. Patients who have had systemic anti-cancer therapy administered in the 14 days prior to IP administration.\n6. Has undergone or plans to undergo PET or single-photon emission computerized tomography (SPECT) imaging with any other FAPi imaging agent within 6 months prior to or after participating in this trial.\n7. History of QT\u002FQTc interval prolongation, a marked baseline QT\u002FQTc interval prolongation (e.g., repeated demonstration of a QTc interval, calculated with Fridericia's correction, \\> 450 milliseconds) or taking medication known to cause QT\u002FQTc prolongation.\n8. A history of additional risk factors for Torsades de Pointes (e.g., heart failure, hypokalemia, family history of long QT syndrome).\n\nExclusion Criteria: Part 2\n\n1. Patients who have had neoadjuvant anti-cancer therapy administered in the 14 days prior to IP administration.\n2. Evidence of metastatic or advanced, inoperable disease.\n3. Unlikely to comply with protocol procedures, restrictions and requirements and judged by the investigator to be unsuitable for participation.\n4. Known pregnancy or breastfeeding.\n5. Any PET scan done within 10 physical half-lives of the PET agent prior to receiving study intervention.\n6. Patients participating in another clinical trial at the time of screening for this study.\n7. Has undergone or plans to undergo PET or SPECT imaging with any other FAPi imaging agent within 6 months prior to or after participating in this trial.\n8. History of QT\u002FQTc interval prolongation, a marked baseline QT\u002FQTc interval prolongation (e.g., repeated demonstration of a QTc interval, calculated with Fridericia's correction, \\> 450 milliseconds) or taking drugs known to cause QT\u002FQTc prolongation.\n9. A history of additional risk factors for Torsades de Pointes (e.g., heart failure, hypokalemia, family history of long QT syndrome","15 Years",{"count":311,"type":20},26,[60,95],"This is a multicenter, open-label, prospective Phase 1\u002F2a study to assess safety and tolerability, establish dosimetry and to identify an optimal imaging dose (radioactivity) and imaging time window of 64Cu-LNTH-1363S, and to compare its imaging biodistribution with FAP expression by IHC in patients with sarcomas or GIT cancers. The study will be conducted in 2 parts (Part 1 and Part 2).",[26,315,316,317,318,319],"Esophageal Cancer","Gastric Cancer","Pancreatic Cancer","Colorectal Cancer","Sarcoma",[321,322,323],"FAPi","Imaging","64Cu-LNTH-1363S","2025-08-06",{"date":326,"type":40},"2025-08-12",{"date":328,"type":20},"2025-08",{"date":330,"type":20},"2026-04",{"name":332,"class":166},"Lantheus Medical Imaging",5]