[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"paragangliomas\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:paragangliomas":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,50],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":32,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100548961","phase-1-somatostatin-receptors-sstr-agonist-212pbvmt-alpha-net-in-metastatic-or-inoperable-sstr-gastrointestinal-neuroendocrine-tumor-and-pheochromocytomaparaganglioma-previously-treated-with-systemic-targeted-radioligand-therapy-100548961",false,"NCT06427798","Somatostatin-Receptors (SSTR)-Agonist [212Pb]VMT-alpha-NET in Metastatic or Inoperable SSTR+ Gastrointestinal Neuroendocrine Tumor and Pheochromocytoma\u002FParaganglioma Previously Treated With Systemic Targeted Radioligand Therapy","Phase I\u002FII Trial of Systemic Targeted Radioligand Therapy (TRT) With Somatostatin-Receptors (SSTR)-Agonist [212Pb]VMT-alpha-NET in Metastatic or Inoperable SSTR Positive (SSTR+) Gastrointestinal (GI) Neuroendocrine Tumors (NET) and Pheochromocytoma\u002FParagangliomas Previously Treated With Systemic Radioligand Therapy","* INCLUSION CRITERIA:\n* Participants must have histopathologically confirmed gastrointestinal neuroendocrine tumors (GI NET) or pheochromocytoma\u002Fparaganglioma (PPGL) cancers that are metastatic or inoperable per Standard of Care.\n* Have received at least 1 prior systemic radioligand therapy for definitive therapeutic purposes. Note: Participants with prior external beam radiation treatment (EBRT) will also be eligible as long as they have had at least 1 prior administration of a systemic radioligand therapy.\n* Must have at least 1 measurable lesion by RECIST 1.1 (phase II only).\n* History of progression by imaging per RECIST 1.1 or clinically (defined as increase in severity or frequency of symptoms related to disease) within the past 36 months prior to the first dose of \\[203Pb\\]VMT-alpha-NET.\n* Evidence of somatostatin receptors (SSTR) expression on at least 50 percent of the radiographically identifiable (i.e., visible on an anatomic scan such as CT or magnetic resonance imaging \\[MRI\\]) tumor, as indicated by a positive (uptake qualitatively identifiable as above the local background) on SSTR PET scan.\n* Age \\>= 18 years.\n* ECOG performance status \\\u003C= 1.\n* Participants must have adequate organ and marrow function as defined below:\n\n  * Leukocytes: 3,000\u002Fmicroliter\n  * Absolute Neutrophil Count: 1,500\u002Fmicroliter\n  * Platelets: 100,000\u002Fmiroliter\n  * Hemoglobin: \\>= 9.0 g\u002FdL\n  * Total bilirubin: within normal institutional limits. Note: \\\u003C= 5 X institutional upper limit of normal (ULN) if bilirubin elevation is due to a benign process such as Gilbert syndrome\n  * AST: \\\u003C= 2.5 X institutional ULN\n  * ALT: \\\u003C= 2.5 X institutional ULN\n  * Creatinine: within normal institutional limits\n\nOR\n\n* Calculated creatinine clearance (glomerular filtration rate (eGFR): \\>= 60 mL\u002Fmin\u002F1.73 m\\^2 for participants with creatinine levels above institutional normal\n\n  * Participants with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression at screening.\n  * Participants with new or progressive brain metastases or leptomeningeal disease are eligible as long as the participant is asymptomatic and not requiring medication for symptom control from the brain lesions at screening.\n  * Participants seropositive for human immunodeficiency virus (HIV) must:\n* be on effective anti-retroviral therapy; and\n* have an undetectable viral load at screening.\n* Participants seropositive for hepatitis B virus (HBV), must have HBV viral load undetectable at screening.\n\n  -Participants seropositive for hepatitis C virus (HCV) must:\n* received curative treatment; and\n* have an undetectable HCV viral load at screening.\n\n  * Participants may enroll in this study while on another therapeutic trial in order to start the screening process. However, all other investigational agents should be stopped at least 28 days prior to receiving \\[203Pb\\]VMT-alpha-NET.\n  * Individuals of child-bearing potential (IOCBP) and individuals who can father children must agree to use an effective method of contraception (barrier, hormonal, intrauterine device \\[IUD\\], surgical sterilization, abstinence) at study entry and at least 6 months after the last dose of the study agent(s).\n  * Nursing participants must be willing to discontinue nursing from study treatment initiation through 6 months after the last dose of the study agents.\n  * The ability of the participant to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to VMT-alpha-NET.\n* Positive Beta human chorionic gonadotropin (Beta-HCG) serum or urine pregnancy test performed in i IOCBP at screening.\n* QTc \\> 450 ms on electrocardiogram (EKG) at screening. Note: Framingham correction for QTc will be used.\n* History of or detection at screening of active\u002Funtreated secondary malignancy except nonmelanoma skin cancer and carcinoma in situ of the uterine cervix.\n* Uncontrolled intercurrent illness, factors, evaluated by medical history and physical exam which would potentially increase in the risk of the participant.","ALL","18 Years","120 Years",{"count":20,"type":21},66,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","Background:\n\nGastrointestinal neuroendocrine tumors (GI NET) are a type of cancer that affects the stomach and intestines; pheochromocytoma\u002Fparagangliomas (PPGL) are tumors that grow in or near the adrenal glands. Both of these types of tumor have high levels of a protein called somatostatin receptors (SSTR) on their surfaces. Researchers want to test a treatment that targets SSTR.\n\nObjective:\n\nTo test a drug (\\[212Pb\\]VMT-alpha-NET) in people with GI NET or PPGL. The drug has 2 components: a protein to bind to SSTR and a radioactive agent to kill the cancer cells.\n\nEligibility:\n\nAdults aged 18 years or older with GI NET or PPGL tumors that have spread and cannot be removed with surgery.\n\nDesign:\n\nParticipants will be screened. They will have a physical exam, with imaging scans, blood tests, and tests of their heart function.\n\n\\[212Pb\\]VMT-alpha-NET is given through a tube attached to a needle inserted into a vein (infusion). Treatment will be given in four 8 week cycles. Participants will receive the drug on the first day of each cycle. They will remain in the clinic at least 4 hours after each infusion and may need to stay in the hospital for up to 48 hour for monitoring and testing. They will have blood tests every week of each cycle.\n\nSome participants will also get a related study drug (\\[203Pb\\]VMT-alpha-NET). They will receive this drug a few days before the first 2 cycles. At 4, 24, and 48 hours after each infusion, they will have whole body scans. These scans will show where the study drug went in their body.\n\nFollow-up visits will continue for 10 years....",[28,29,30,31],"Somatostatin Receptor Positive","Gastrointestinal Neuroendocrine Tumors","Pheochromocytoma","Paragangliomas",[33,34,35,36],"212Pb","Targeted Therapies","Image-Guided Dosimetry","VMT- -NET","RECRUITING","2026-06-26",{"date":40,"type":41},"2026-06-29","ACTUAL",{"date":43,"type":41},"2025-02-07",{"date":45,"type":21},"2039-07-01",{"name":47,"class":48},"National Cancer Institute (NCI)","NIH",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":82},"100634369","italian-multicenter-experience-with-radioreceptor-assisted-therapy-prrt-100634369","NCT07538791","Italian Multicenter Experience With Radioreceptor-assisted Therapy (PRRT)","Italian Multicenter Experience With Radioreceptor-assisted Therapy (PRRT) in Pheochromocytomas and Paragangliomas: a Retrospective Analysis","PRRT-PGL-PHEO","Inclusion Criteria:\n\n* Documented diagnosis of pheochromocytoma or paraganglioma (PPGL) (sporadic or hereditary forms) with unresectable or metastatic disease.\n* Treatment with peptide receptor radionuclide therapy (PRRT) administered with ⁷⁷Lu and\u002For ⁹⁰Y (including combination regimens), with t0 (first PRRT administration) between January 1, 2000 and February 28, 2024.\n* Availability of essential data required by the protocol to document exposure (PRRT) and outcomes, including: PRRT start date (t0) and treatment details (radioisotope(s), number of cycles and\u002For cycles actually administered, intervals when available), At least one post-treatment evaluation suitable for determining disease control rate (DCR) (morphological imaging by CT\u002FMRI ± functional imaging by PET\u002FCT, and available clinical data), Follow-up information suitable for determining progression-free survival (PFS) within the predefined time window.\n* Availability of follow-up up to 12 months from end of treatment (EoT), or documentation of progression and\u002For death occurring within 12 months.\n* Required data and source documents are available at the enrolling center or obtainable from other Italian centers (e.g., PRRT-administering center or centers performing imaging\u002Fevaluations) through formal data transfer agreements (e.g., DTA) in compliance with applicable regulations.\n* Privacy\u002Fconsent requirements (general framework):\n\nFor living and contactable patients, consent for personal data processing will be managed according to the requirements\u002Fassessment of the Ethics Committee.\n\nFor deceased or non-contactable patients after reasonable documented efforts, inclusion may occur without consent, as it falls under situations of \"impossibility to inform the subjects,\" in accordance with applicable regulations (Article 110 of the Italian Privacy Code and subsequent amendments), subject to Ethics Committee evaluation\u002Fopinion and implementation of appropriate safeguards.\n\nExclusion Criteria:\n\n* Patients who did not receive at least one cycle of peptide receptor radionuclide therapy (PRRT).",{"count":59,"type":21},210,"OBSERVATIONAL","This multicenter retrospective Italian study evaluates the efficacy and safety of PRRT in patients with advanced, unresectable or metastatic pheochromocytomas and paragangliomas (PPGL). Data from \\~210 patients treated between 2000 and 2024 will be analyzed. The primary endpoint is disease control rate (DCR). Secondary endpoints include progression-free survival (PFS), overall survival (OS), and prognostic factors.",[63,31],"Pheochromocytomas",[65,66,67,68,69,70],"PPGL","PRRT","PHEO","PGL","Somatostatin receptors","Peptide Receptor Radionuclide Therapy","NOT_YET_RECRUITING","2026-04-21",{"date":74,"type":41},"2026-04-24",{"date":76,"type":21},"2026-04-30",{"date":78,"type":21},"2028-04-30",{"name":80,"class":81},"Azienda USL Reggio Emilia - IRCCS","OTHER_GOV",10]