[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"neoplastic-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:neoplastic-disease":24},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,51,95,118],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":16,"targetDuration":4,"studyType":19,"phases":20,"briefSummary":22,"conditions":23,"keywords":26,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100368957","phase-1-indocyanine-green-icg-guided-tumor-resection-100368957",false,"NCT04084067","Indocyanine Green (ICG) Guided Tumor Resection","Inclusion Criteria:\n\n* Patients with a primary or relapsed solid tumor or lymphoma who require excision of the tumor or metastatic lesions.\n\nExclusion Criteria:\n\n* Subjects with a history of iodide allergies.\n* Inability or unwillingness of research participant or legal guardian\u002Frepresentative to give written informed consent.\n* Patients with benign pathology.\n* Patients with brain tumors.\n* Pregnant female.\n* Patients with unilateral Wilms Tumor.","ALL",{"count":17,"type":18},230,"ESTIMATED","INTERVENTIONAL",[21],"PHASE1","This is a study to assess the ability of Indocyanine Green (ICG) to identify neoplastic disease. For many pediatric solid tumors, complete resection of the primary site and\u002For metastatic deposits is critical for achieving a cure. An optimal intra-operative tool to help visualize tumor and its margins would be of benefit. ICG real-time fluorescence imaging is a technique being used increasingly in adults for this purpose. We propose to use it during surgery for pediatric malignancies. All patients with tumors that require localization for resection or biopsy of the tumor and\u002For metastatic lesions will be eligible.\n\nPrimary Objective\n\nTo assess the feasibility of Indocyanine Green (ICG)-mediated near-infrared (NIR) imagery to identify neoplastic disease during the conduct of surgery to resect neoplastic lesions in children and adolescents. NIR imaging will be done at the start of surgery to assess NIR-positivity of the lesion(s) and at the end of surgery to assess completeness of resection. Separate assessments will be made for the following different histologic categories:\n\n1. Osteosarcoma\n2. Neuroblastoma\n3. Metastatic pulmonary deposits - closed to accrual\n\nExploratory Objectives\n\n1. To compare the ICG uptake by primary vs metastatic site and pre-treated (chemotherapy, radiation, or both) vs non-pre-treated.\n2. Assess the sensitivity and specificity of NIR imagery to find additional lesions not identified by standard of care intraoperative inspection and tactile feedback.\n3. Assess the sensitivity and specificity of NIR imagery to find additional lesions not identified on preoperative diagnostic imaging.\n4. Assess the sensitivity and specificity of NIR imagery for identifying residual disease at the conclusion of a tumor resection.\n\nSeparate assessments will be made for the following different histologic categories based on their actual enrollment; this includes but is not limited to analyzing multiple arms together:\n\n1. Ewing Sarcoma\n2. Rhabdomyosarcoma (RMS)\n3. Non-Rhabdomyosarcoma Soft Tissue Sarcoma (NRSTS)\n4. Renal tumors\n5. Liver tumors, lymphoma, other rare tumors, and nodules of unknown etiology",[24,25],"Neoplastic Disease","Solid Tumor",[27,28,29,30,24,31,32,33,34,25,35,36,37],"Ewing Sarcoma","Liver tumor","Lymphoma","Metastatic pulmonary deposits","Neuroblastoma","Non-Rhabdomyosarcoma Soft Tissue Sarcoma","Nodules of unknown etiology","Osteosarcoma","Rhabdomyosarcoma","Renal tumors","Rare tumors","RECRUITING","2026-04-24",{"date":41,"type":42},"2026-04-30","ACTUAL",{"date":44,"type":42},"2020-02-07",{"date":46,"type":18},"2027-12-31",{"name":48,"class":49},"St. Jude Children's Research Hospital","OTHER",1,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":15,"minAge":59,"maxAge":4,"enrollmentInfo":60,"targetDuration":4,"studyType":19,"phases":62,"briefSummary":64,"conditions":65,"keywords":71,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":5},"100600687","phase-3-study-of-tlx101-tx-plus-standard-of-care-soc-versus-soc-alone-for-the-treatment-of-patients-with-recurrent-glioblastoma-100600687","NCT07100730","Study of TLX101-Tx Plus Standard of Care (SoC) Versus SoC Alone for the Treatment of Patients With Recurrent Glioblastoma","A Global, Multicenter, Prospective, Controlled, Open-Label Pivotal Study of Iodofalan (131I) Solution for Injection (TLX101-Tx) Plus Lomustine Versus Lomustine Alone in Patients With Radiographically Confirmed Recurrent Glioblastoma at First Recurrence (IPAX BrIGHT [IPAX-3])","IPAX BrIGHT","Inclusion Criteria:\n\n1. Previously confirmed neuropathological diagnosis of glioblastoma, IDH-wildtype according to the WHO 2021 classification.\n2. Radiographic evidence of first recurrence or progressive glioblastoma according to RANO 2.0 criteria after first-line treatment with biopsy or maximal safe resection and standard radiotherapy or chemoradiotherapy having occurred at least 3 months after the end of prior radiotherapy. Prior first-line therapy may include a combination of:\n\n   1. Any systemic antineoplastic treatment other than nitroureas\n   2. Tumor-treating fields\n   3. Conventionally fractionated or abbreviated (minimum 15 fractions) radiotherapy\n3. Increased \\[18F\\]\\]FET PET tracer uptake inside or in the vicinity of tumor. Specifically, amino acid-based molecular imaging using \\[18F\\]FET PET will be evaluated following co-registration with MRI. The allocated physician\u002Freader will assess whether the observed pathologically increased amino acid uptake is located within the tumor or in the vicinity. This determination will serve as a guidance to confirm whether the uptake is tumor-associated. The uptake must be clearly discernible from background activity and measurable per PET RANO 1.0 criteria, as determined by central review.\n4. Tumor debulking for recurrent, progressive disease is allowed. The patient must have post-surgical (4-6 weeks) radiographic evidence for residual tumor according to RANO 2.0 with increased \\[18F\\] FET PET uptake and measurable disease according to PET RANO 1.0.\n5. 18 years or older\n6. Have the capacity to understand the study and be willing to comply with all protocol requirements.\n7. Must have an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-2 or KPS≥70\n8. Patients on stable, not increasing dose of steroids in the previous 7 days can be included in the study\n9. Adequate hematological, liver and renal function at the time of screening.\n10. Females of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose of investigational drug product; must not be breast-feeding; and must agree to use a highly effective method of contraception during treatment and for 6 months following last dose of investigational product.\n11. Male patients must agree to use condoms during sex during the treatment period and for 3 months after the last dose of the investigational drug product and must not make semen donations during treatment and for 6 months following last dose of investigational drug product. For male patients with female partners of childbearing potential, females must agree to use a highly effective method of contraception during the treatment period and for 6 months following last dose of investigational drug product.\n\nExclusion Criteria:\n\n1. Prior course with external beam radiation to the brain in the past 3 months. Prior treatment with brachytherapy in the brain.\n2. Treatment with bevacizumab within the prior 6 weeks.\n3. Known contraindication to imaging tracer or any product of contrast media and MRI contraindications including implanted medical devices. Unable to lie still for at least 20 min or the duration of the MRI and PET imaging or the need for general anesthesia as part of the imaging procedure.\n4. History or evidence of delayed-type hypersensitivity-dependent chronic infection (ie, tuberculosis, systemic fungal or parasitic infection).\n5. Radiographic progression based on RANO 2.0 associated with clinical deterioration and life expectancy less than 3 months.\n6. Hemostaseologic conditions, precluding catheterization or invasive procedures.\n7. Clinically significant illness or clinically relevant trauma within 2 weeks before the administration of the investigational product.\n8. Known liver or kidney disease, such as hepatitis, cirrhosis, renal failure.\n9. Severe chronic or active infections (including active tuberculosis, hepatitis B virus, or hepatitis C virus infection) requiring systemic therapy.\n10. Ongoing toxicity \\> Grade 2 NCI-CTCAE (version 5.0) from previous standard or investigational therapies.\n11. Administration of another investigational product within 90 days prior to screening.\n12. Expected non-compliance with longer-term admission at isolated nuclear medicine ward per regional regulations.\n13. Inability to complete the needed investigational and standard imaging examinations due to any reason (ie, severe claustrophobia, inability to lie still for the entire imaging time).\n14. Patients with known phenylketonuria.\n15. Presence of any other condition that may increase the risk associated with study participation or interfere with the interpretation of study results, and, in the opinion of the study investigator, would make the patient inappropriate for entry into the study.","18 Years",{"count":61,"type":18},50,[63],"PHASE3","This global clinical trial which evaluates the efficacy and safety of TLX101-Tx, an investigational radiopharmaceutical therapy, in combination with lomustine versus lomustine alone in adult patients with first recurrence of glioblastoma. TLX101-Tx delivers targeted radiation to glioblastoma cells. The trial is conducted in two parts: Part 1 assesses safety and radiation dosing; Part 2 is a randomized comparison of the combination therapy against standard care.",[24,66,67,68,69,70],"Glioblastoma","Glioblastoma (GBM)","Glioblastoma Multiform","Glioblastoma Multiforme, Adult","Glioblastoma Multiforme (GBM) WHO Grade IV",[72,73,74,75,76,77,66,78,79,80,81,82,83,84],"Lomustine","Radiation Therapy","Radiopharmaceuticals","Positron-Emission Tomography","Brain Neoplasms","Glioblastoma Multiforme","GBM","Neoplasm Recurrence, Local","Central Nervous System Neoplasms","Brain cancer","Recurrent brain tumor","Brain tumor recurrence","LAT-1 targeted therapy","2026-04-15",{"date":87,"type":42},"2026-04-16",{"date":89,"type":42},"2025-11-02",{"date":91,"type":18},"2027-11",{"name":93,"class":94},"Telix Pharmaceuticals (Innovations) Pty Limited","INDUSTRY",{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":101,"eligibilityCriteria":102,"healthyVolunteers":11,"sex":15,"minAge":59,"maxAge":4,"enrollmentInfo":103,"targetDuration":4,"studyType":19,"phases":105,"briefSummary":106,"conditions":107,"keywords":108,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},"100473888","phase-1-131i-tlx-101-for-treatment-of-newly-diagnosed-glioblastoma-ipax-2-100473888","NCT05450744","131I-TLX-101 for Treatment of Newly Diagnosed Glioblastoma (IPAX-2)","A Phase 1 Safety and Dose Finding Study of 131I -TLX101 Plus Standard of Care in Patients With Newly Diagnosed Glioblastoma","IPAX-2","Inclusion Criteria:\n\n1. Understand and voluntarily sign the informed consent form prior to any study related procedure and\u002For assessments being conducted.\n2. Are Male or Female, and aged 18 years or older, at the time of signing the informed consent.\n3. Have histologically confirmed intracranial glioblastoma (per WHO 2021 definition) following surgical resection. Tumours primarily localised in the infratentorial compartment will be excluded.\n4. Have had prior surgery for glioblastoma, but no systemic therapy or radiation therapy for GBM.\n5. Have a Karnofsky Performance Status ≥70.\n6. Plan to begin chemoradiation therapy 3-6 weeks after surgical resection with Stupp regimen.\n7. Have adequate organ function at Screening:\n\n   7.1 Bone marrow: 7.1.1 Leukocytes ≥3,000\u002FmL 7.1.2 Absolute neutrophil count ≥1500\u002FmL 7.1.3 Platelets ≥100,000\u002FmL 7.1.4 Haemoglobin ≥9g\u002FdL 7.2 Liver function: 7.2.1 Total bilirubin ≤1.5×the upper limit of normal (ULN). For patients with known Gilbert's Syndrome ≤3×ULN is permitted 7.2.2 Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤2.5×ULN 7.3 Renal function: 7.3.1 Serum\u002Fplasma creatinine ≤1.5×ULN or creatinine clearance ≥50 mL\u002Fmin\n8. Have at least 6 slides without staining or a tissue block (frozen or paraffin-embedded) available from a previous biopsy or surgery (tumour sample previously archived).\n9. Have the capacity to understand the study and be able and willing to comply with all protocol requirements, including compliance with the radiation protection guidelines (including hospital admissions and isolation) that are applied by the treating institution to protect their contacts and the public.\n10. Agree to practice adequate precautions to prevent pregnancy to avoid potential problems associated with radiation exposure to the unborn child.\n11. Females must have a negative pregnancy test at screening and on dosing day, must not be lactating.\n\nExclusion Criteria:\n\n1. Are unable to provide signed informed consent\n2. Have had prior treatment for glioma, excluding surgery.\n3. Are unable to undergo contrast-enhanced MRI.\n4. Intend to be treated with tumor-treating fields prior to progression.\n5. Have a history or evidence of delayed-type hypersensitivity (DTH)-dependent chronic infection (e.g., tuberculosis, systemic fungal or parasitic infection), potentially exacerbating under systemic corticoid therapy.\n6. Have a known history of allergy TMZ, any excipient in the study medication or any other intravenously administered human proteins\u002Fpeptides\u002Fantibodies.\n7. Have haemostaseologic conditions, precluding catheterisation or invasive procedures.\n8. Have had phenylketonuria diagnosis previously\n9. Have any medical condition that in the opinion of the Investigator may interfere with the participant's ability to adhere to the study or may impose a risk to the participant's health.\n10. Major trauma including major surgery (such as abdominal\u002Fcardiac\u002Fthoracic surgery) within 3 weeks of administration of study treatment except surgery on primary tumour.\n11. Pregnant, breastfeeding or planning to get pregnant during the duration of the study.\n12. Requirement of chronic administration of high dose corticosteroids or other immunosuppressant drugs. Limited or occasional use of corticosteroids to treat or prevent acute adverse reactions is not considered an exclusion criterion.\n13. Have presence of active and uncontrolled infections or other severe concurrent disease, which, in the opinion of the investigator, would place the participant at undue risk or unable to comply with study requirements. HIV-positive participants may be included in the study if they are on a stable dose of anti-retroviral therapy.\n14. Have concurrent malignancies unless the patient has been disease-free without intervention for at least 2 years.\n15. Have taken growth factors or immunomodulatory agents within 7 days prior to the administration of study treatment.\n16. Have serious, non-healing wound, ulcer, or bone fracture.\n17. Have a requirement of concurrent use of other anti-cancer treatments or agents other than study medication.\n18. Have received any other IMP within 90 days prior to the planned administration of study drug.\n19. Have uncontrolled Hashimoto's or Grave's disease\n20. Have on-going and unresolved Grade ≥ 1 AEs following surgical resection",{"count":104,"type":18},12,[21],"This is an open label, single arm, parallel-group, multicentre, and dose finding study to evaluate the safety of ascending radioactive dose levels of 131I-TLX101 administered intravenously in combination with best standard of care in newly diagnosed GBM patients.",[24,66,77],[66],"2026-01-16",{"date":111,"type":42},"2026-01-21",{"date":113,"type":42},"2023-04-01",{"date":115,"type":18},"2026-06",{"name":93,"class":94},6,{"id":119,"slug":120,"hasResults":11,"nctId":121,"briefTitle":122,"officialTitle":122,"acronym":4,"eligibilityCriteria":123,"healthyVolunteers":11,"sex":15,"minAge":59,"maxAge":4,"enrollmentInfo":124,"targetDuration":4,"studyType":19,"phases":125,"briefSummary":127,"conditions":128,"keywords":4,"overallStatus":129,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":4},"100579525","group-exercise-in-cancer-patients-under-active-treatment-feasibility-pilot-study-100579525","NCT06825429","Group Exercise in Cancer Patients Under Active Treatment: Feasibility Pilot Study.","Inclusion Criteria:\n\n* neoplastic tumor\n* age\\>= 18\n* prognosis\\> 12 months\n* ECOG \\\u003C=2\n* Walking with\u002F without aids\n* clinically stable\n* signed informed consent\n* Patients with bone metastases with ECOG from 0-1 suitable results\n\nExclusion Criteria:\n\n* sensory deficits who cannot perform physical exercise\n* cognitive impairment that compromises collaboration and questionnaire filling\n* patients with pathologies (e.g. neurological, psychiatric) that do not allow the obtaining of valid informed consent",{"count":61,"type":18},[126],"NA","The aim of this study to investigate the feasibility in hospital reality, of a group exercise program for oncology patients under active treatment and evaluate its impact on some outcomes considered relevant from both clinical and subjective point of view.",[24],"NOT_YET_RECRUITING","2025-02-11",{"date":132,"type":42},"2025-02-13",{"date":134,"type":18},"2025-03",{"date":136,"type":18},"2027-09",{"name":138,"class":49},"IRCCS Azienda Ospedaliero-Universitaria di Bologna"]