[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"gastrointestinal-neuroendocrine-tumors\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:gastrointestinal-neuroendocrine-tumors":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,50,81],{"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":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":60,"conditions":61,"keywords":70,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":49},"100552955","phase-1-212pbvmt-alpha-net-in-metastatic-or-inoperable-somatostatin-receptor-positive-gastrointestinal-neuroendocrine-tumors-pheochromocytomaparagangliomas-small-cell-lung-renal-cell-and-head-and-neck-cancers-100552955","NCT06479811","[212Pb]VMT-Alpha-NET in Metastatic or Inoperable Somatostatin-Receptor Positive Gastrointestinal Neuroendocrine Tumors, Pheochromocytoma\u002FParagangliomas, Small Cell Lung, Renal Cell, and Head and Neck Cancers","Phase I Trial of [212Pb]VMT-Alpha-NET in Metastatic or Inoperable Somatostatin-Receptor Positive Gastrointestinal Neuroendocrine Tumors, Pheochromocytoma\u002FParagangliomas, Small Cell Lung, Renal Cell, and Head and Neck Cancers","* INCLUSION CRITERIA:\n* Participants must have histopathologically confirmed gastrointestinal neuroendocrine tumors (GI NET), pheochromocytoma\u002Fparaganglioma (PPGL), small cell lung cancers (SCLC), kidney cancers (KC), or Head \\& Neck cancers (nasopharyngeal carcinoma \\[NPC\\], olfactory neuroblastoma \\[ONB\\], sinonasal neuroendocrine carcinoma \\[SNEC\\]) that are metastatic or inoperable per Standard of Care. Note: for KC, all histopathologies of kidney cancers are eligible as long as it is a primary renal neoplasm.\n* Required prior therapies:\n* GI NET, PPGL, H\\&N: no specific prior therapy is needed.\n* SCLC: At least one prior line of standard of care systemic treatment such as chemotherapy and\u002For immunotherapy.\n* KC: Renal cell carcinoma (RCC) participants should have received at least one line of prior therapy in the metastatic setting and should have received at least one Programmed cell death protein 1 (PD1) \u002F Programmed death-ligand 1 (PDL1)-targeted immune checkpoint inhibitor as well as one agent targeting the VEGF pathway. Participants with fumarate hydratase (FH) deficient RCC should have received at least one prior line of systemic therapy (such as bevacizumab plus erlotinib). No prior therapy is needed for participants with other histologic subtypes.\n* Have NOT received prior systemic radioligand therapy for definitive therapeutic purposes. Prior external beam radiation therapy is allowed.\n* History of disease progression by imaging (e.g., 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% 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\u002Fmicroliter\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\n  * Participants seropositive for hepatitis B virus (HBV), must have HBV viral load undetectable at screening.\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  * 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 up to 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* Any investigational agents should be stopped at least 28 days prior to the first dose of \\[203Pb\\]VMT-Alpha-NET.\n* Systemic therapy should be stopped at least 28 days prior to the first dose of \\[203Pb\\]VMT-Alpha-NET (participants with prior systemic therapies for their malignancy only, except participants with SCLC).\n* Systemic therapy should be stopped at least 14 days prior to the first dose of \\[203Pb\\]VMT-Alpha-NET (participants with SCLC only).\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 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.",{"count":58,"type":21},120,[24],"Background:\n\nSome cancers have high levels of proteins called somatostatin receptors (SSTRs) on the surface of the tumors. These tumors can be in the lung, head and neck, digestive tract, kidneys, and in or near the adrenal glands. Researchers want to know if drug treatments that target SSTRs can help shrink these types of tumors.\n\nObjective:\n\nTo test a study drug (\\[212Pb\\]VMT-Alpha-NET) in people with tumors that have SSTRs.\n\nEligibility:\n\nPeople aged 18 years and older with tumors of the lung, kidneys, head and neck, digestive tract, or adrenal glands that have SSTRs. Their tumors must have spread to other organs and cannot be removed with surgery.\n\nDesign:\n\nParticipants will be screened. They will have a physical exam with blood and urine tests. They will have imaging scans and a test of their heart function. A sample of tumor tissue may be collected if one is not already available.\n\n\\[212Pb\\]VMT-Alpha-NET is given through a tube attached to a needle inserted into a vein. The drug will be given on the first day of four 8-week cycles. Participants will stay in the hospital for a few nights after each dose. They will have blood tests once a week during 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 up to 6 years after the last treatment.",[62,63,64,65,28,66,67,68,69,29],"Sinonasal Neuroendocrine Carcinoma","Nasopharyngeal Carcinoma","Esthesioneuroblastoma","Olfactory Neuroblastoma","Small Cell Lung Cancers","Pheochromocytoma\u002FParagangliomas","Kidney Cancers","Head and Neck Tumors",[33,71,35,72],"Targeted alpha Therapy","VMT-alpha-NET","2026-06-11",{"date":75,"type":41},"2026-06-12",{"date":77,"type":41},"2025-08-19",{"date":79,"type":21},"2032-01-01",{"name":47,"class":48},{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":4,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":88,"targetDuration":4,"studyType":22,"phases":90,"briefSummary":91,"conditions":92,"keywords":96,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":49},"100223376","phase-2-stereotactic-body-radiation-therapy-sbrt-for-unresectable-liver-metastases-100223376","NCT02185443","Stereotactic Body Radiation Therapy (SBRT) for Unresectable Liver Metastases","Stereotactic Body Radiation Therapy for the Treatment of Unresectable Liver Metastases in Patients With Colorectal Adenocarcinoma, Carcinoma of the Anal Canal and Gastrointestinal Neuroendocrine Tumors","Inclusion Criteria:\n\n* Karnofsky Performance Scale (KPS) equal or greater than 70\n* 1 to 4 liver metastases with an individual maximum diameter of up to 5 cm\n* Lesions considered unresectable or patients considered unfit for surgery\n* Histology of the primary tumor: colorectal adenocarcinoma, carcinoma of the anal canal or gastrointestinal neuroendocrine tumors.\n* Absence of evidence of extra-hepatic disease or extra-hepatic disease to be treated with curative intent.\n* Minimum interval of 2 weeks between systemic chemotherapy and SBRT.\n* Adequate bone marrow function defined as:\n* absolute neutrophils count \\> 1,800 cells \u002F mm 3\n* platelets \\> 100,000 cells \u002F mm 3\n* hemoglobin \\> 8.0 g \u002F dl ( transfusion or other intervention accepted)\n\nExclusion Criteria:\n\n* Concomitant chemotherapy\n* Prior radiotherapy to the upper abdomen\n* Pregnancy\n* Underlying Cirrhosis\n* Active hepatitis or clinically significant liver failure\n* Prior invasive neoplasm except for non-melanoma skin cancer, or unless more than five years without evidence of disease\n* Severe Comorbidity\n* Current anticoagulant treatment",{"count":89,"type":21},43,[25],"This is a Phase II study to determine the efficacy of SBRT to treat liver metastases in patients with Colorectal Adenocarcinoma, Carcinoma of the Anal Canal and Gastrointestinal Neuroendocrine Tumors that are not amenable to surgery. Patients should have no evidence of extra-hepatic disease or have disease that is planned to be treated with curative intent.\n\nTherefore, SBRT is being considered as a potentially curative procedure.",[93,94,95,29],"Liver Metastases","Colorectal Cancer","Anal Canal Cancer",[97,98,99,100,101,102],"SBRT","radiation","Neoplasm Metastasis","Colorectal Neoplasms","Anal Canal","Neuroendocrine Tumors","2024-12-04",{"date":105,"type":41},"2024-12-09",{"date":107,"type":4},"2014-05",{"date":109,"type":21},"2026-12",{"name":111,"class":112},"University of Sao Paulo","OTHER"]