[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cns-tumors\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cns-tumors":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,61],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":36,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":49,"lastUpdatePostDateStruct":50,"startDateStruct":53,"completionDateStruct":55,"leadSponsor":57,"locationsCount":60},"100549997","phase-1-phase-i-trial-to-determine-the-dose-and-evaluate-the-pk-and-safety-of-lutetium-lu-177-edotreotide-therapy-in-pediatric-participants-with-sstr-positive-tumors-100549997",false,"NCT06441331","Phase I Trial to Determine the Dose and Evaluate the PK and Safety of Lutetium Lu 177 Edotreotide Therapy in Pediatric Participants With SSTR-positive Tumors","A Multicenter, Open-label, Interventional Phase I Trial to Determine the Dose and Evaluate the Pharmacokinetics (PK) and Safety of Lutetium Lu 177 Edotreotide Targeted Radiopharmaceutical Therapy (RPT) as Monotherapy or Following Standard of Care (SoC) for the Treatment of Somatostatin Receptor-positive Tumors in the Pediatric Population (KinLET).","KinLET","Key Inclusion Criteria:\n\n* Participants aged ≥ 2 years and \\\u003C 18 years\n* Confirmed diagnosis somatostatin receptor-positive (SSTR-positive) disease.\n* Tumor which is relapsed or is refractory to at least one line of previous therapy\n* Positive SSTR protein expression confirmed by immunohistochemistry of a tumor histology sample\n* Radioactivity uptake within the primary tumor or metastatic tumor sites measured by locally available SRIs ( 111In-based, 99mTc-based, or 68Ga-based SSTR single-photon emission computed tomography (SPECT)\u002F computed tomography (CT) or positron emission tomography (PET)\u002FCT imaging, which is higher than the liver uptake)\n* Participants must have recovered from the acute treatment related toxicities (defined as ≤ grade 1 if not defined in eligibility criteria, excluding alopecia, stable treated electrolyte abnormalities on replacement and stable treated hypothyroidism) of all prior treatment modality prior to entering this trial\n* In case of sequential treatment followed by SoC or prior therapy, washout period applies before starting targeted RPT\n\nScreening Consent Participant\u002Flegal guardian is willing to sign a screening consent. The screening consent is to be obtained according to institutional guidelines. Assent, when appropriate, will be obtained according to institutional guidelines.\n\nKey Exclusion Criteria:\n\n* Known hypersensitivity to Lutetium Lu 177 Edotreotide, DOTA\u002FEdotreotide, or excipients\n* Previous history of acute leukemia unless in remission for at least two years\n* Extensive bone\u002Fbone marrow involvement as per Investigator's judgement unless peripheral blood stem cells (PBSC) are available at a minimum of 2.5x106 CD34+ cells\u002Fkg\n* Patients who have received previous systemic targeted RPT\n* Previous treatment with metaiodobenzyl guanidine (MIBG) if the predicted overall exposure is expected to exceed 2 Gy (gray) to the bone marrow or 23 Gy to the kidney.\n* Previous treatment with external beam radiation therapy (EBRT) if the predicted overall exposure is expected to exceed more than 2 Gy to the bone marrow or 23 Gy to the kidney.\n* Previous treatment with oncologic immune vaccine or CAR-T cell therapy\n* Bulky disease in the CNS\n* Presence of severe renal, hepatic, electrolyte, cardiovascular, or hematological dysfunction\n* Participants who have received a live-attenuated vaccine up to four weeks prior to enrolment\n* Pregnant or breastfeeding women.\n* Other known malignancies.\n* Serious non-malignant disease.","ALL","24 Months","18 Years",{"count":21,"type":22},20,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","The purpose of the study is to determine the appropriate pediatric dosage and evaluate the pharmacokinetics (PK) and safety of Lutetium Lu 177 Edotreotide Targeted Radiopharmaceutical Therapy (RPT) as a monotherapy or following standard of care (SoC) in participants ≥2 to \\\u003C18 years of age with somatostatin receptor (SSTR)-positive tumors.",[28,29,30,31,32,33,34,35],"Somatostatin Receptor Positive","NETs","Lymphoma","Solid Tumor","CNS Tumors","Rhabdomyosarcoma","Peripheral Primitive Neuroectodermal Tumor","GIST",[37,38,39,30,40,41,42,43,44,45,46,47],"Pediatric","CNS tumors","Solid tumors","Somatostatin Receptor (SSTR)-positive Tumors","Lutetium Lu 177 Edotreotide","Targeted RPT","ITM","GEP-NET","Neuroendocrine tumors","Radiopharmaceutical Therapy","Childhood","RECRUITING","2026-04-27",{"date":51,"type":52},"2026-05-01","ACTUAL",{"date":54,"type":52},"2025-09-26",{"date":56,"type":22},"2034-04",{"name":58,"class":59},"ITM Solucin GmbH","INDUSTRY",5,{"id":62,"slug":63,"hasResults":11,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":11,"sex":17,"minAge":19,"maxAge":69,"enrollmentInfo":70,"targetDuration":4,"studyType":23,"phases":72,"briefSummary":74,"conditions":75,"keywords":4,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":92},"100368775","phase-4-68-ga-dotatate-petmri-in-the-diagnosis-and-management-of-somatostatin-receptor-positive-cns-tumors-100368775","NCT04081701","68-Ga DOTATATE PET\u002FMRI in the Diagnosis and Management of Somatostatin Receptor Positive CNS Tumors.","68Ga(Gallium)-DOTATATE Positron Emission Tomography (PET)\u002FMRI in the Diagnosis and Management of Somatostatin Receptor Positive Central Nervous System CNS Tumors.","DOMINO-START","Inclusion Criteria:\n\n* ≥ 18 years of age\n* Diagnosis of meningioma based on pathology reports and suspected recurrence or residual disease based on standard-of-care MRI\n* Additionally, patients with other somatostatin receptor 2 positive brain tumors, including esthesioneuroblastoma, hemangioblastoma, medulloblastoma, paraganglioma, pituitary adenoma, and SSTR-positive systemic cancers metastatic to the brain will be considered for the purposes of obtaining feasibility data\n* As the investigator's institution, PET\u002FMRI scanner utilizes a 3 Tesla (T) magnet, patients who may be ineligible to undergo 3T MRI but may undergo 1.5 Tesla (T) MRI, will undergo a 1.5T MRI as per clinical standard-of-care and a Ga68-DOTATATE PET\u002FCT with the PET portion to be fused with the 1.5T MRI utilizing fusion software.\n\nExclusion Criteria:\n\n* Contraindications to gadolinium-based contrast agent\n* History of allergic reaction to Gallium-68-DOTATATE\n* Pregnancy","100 Years",{"count":71,"type":22},200,[73],"PHASE4","The study population consists of patients who undergo resection for somatostatin receptor-positive (SSTR-positive) CNS tumors, focusing on meningioma, and including esthesioneuroblastoma, hemangioblastoma, medulloblastoma, paraganglioma, pituitary adenoma, and SSTR-positive systemic cancers metastatic to the brain, such as small cell carcinoma of the lung. The study indication is to determine the diagnostic utility of 68Ga-DOTATATE PET\u002FMRI in the diagnosis and management of patients with SSTR-positive CNS tumors, specifically whether 68Ga-DOTATATE PET\u002FMRI demonstrates utility distinguishing between tumor recurrence and post-treatment change. To date, the utility of Ga-68-DOTATATE PET\u002FMRI in meningioma has not been explored. Investigators have over the past 3 months been able to accrue the largest case series of presently 12 patients in whom Ga-68-DOTATATE PET\u002FMRI demonstrated utility in the assessment of meningioma, including assessment for postsurgical\u002Fpostradiation recurrence, detection of additional lesions not visualized on MRI alone, and evaluation of osseous invasion. Based on this initial experience, investigators intend to study the impact of Ga-68-DOTATATE PET\u002FMRI in the assessment of the extent of residual tumor in patients status post meningioma resection, specifically in patients in whom tumor location limits resectability, patients with World Health Organization (WHO) grade II\u002FIII disease, and patients with history of stereotactic radiosurgery (SRS) who develop postradiation change.",[32,76,77,78,79,80,81],"Meningioma","Esthesioneuroblastoma","Hemangioblastoma","Medulloblastoma","Paraganglioma","Pituitary Adenoma","2025-11-17",{"date":84,"type":52},"2025-11-21",{"date":86,"type":52},"2019-09-04",{"date":88,"type":22},"2038-12-31",{"name":90,"class":91},"Weill Medical College of Cornell University","OTHER",1]