[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"paraganglioma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:paraganglioma":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,20,0,[8,44,113,152,181,211,248,270,321,346,378,404,437,462,485,508,549,572,603,620],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100641367","phase-1-211at-mabg-in-adults-with-advanced-neuroendocrine-cancers-100641367",false,"NCT07661420","211At-MABG in Adults With Advanced Neuroendocrine Cancers","Inclusion Criteria:\n\n1. Adult patients, at least 18 years of age\n2. Advanced neuroendocrine cancers requiring systemic therapy and refractory to, ineligible for, declining, or lacking standard treatments.\n3. I MIBG imaging indicating MIBG-avid disease (radiotracer uptake above background in at least one tumor site) per Investigator\u002FSub-Investigator assessment.\n4. Participants must provide written informed consent prior to study-specific procedures.\n5. ECOG performance status ≤ 2.\n6. Adequate organ function including:\n\n   1. Hemoglobin ≥ 9 g\u002FdL\n   2. Absolute neutrophil count ≥ 1,500\u002Fmm³\n   3. Platelet count ≥ 75,000\u002Fmm³\n   4. Measured or estimated GFR ≥ 60 mL\u002Fmin\n   5. Serum bilirubin ≤ 1.5x upper limit of normal\n   6. ALT\u002FAST each ≤ 2.5x upper limit of normal\n7. Life expectancy at least 3 months as judged by treating physician\n\nExclusion Criteria:\n\n1. Women who are pregnant or breast-feeding will not be eligible for this study.\n2. Inability to tolerate study procedures in the opinion of the investigator or treating physician.\n3. Serious or unstable medical, psychological, or social conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study.\n4. Uncontrolled brain metastasis (Participant must be at least 4 weeks since CNS-directed therapy and no longer requiring corticosteroid therapy).\n5. Anticancer therapy, except hormonal therapy or bone supportive therapies, within 14 days of cycle 1 day 1.\n6. Has a known additional malignancy (other than the disease under study) that has required active systemic treatment within the past 2 years AND for which the natural history or recent\u002Fongoing treatment could likely interfere with study endpoints or safety of the study treatment per Investigator and Medical Director assessment.","ALL","18 Years",{"count":18,"type":19},16,"ESTIMATED","INTERVENTIONAL",[22],"PHASE1","Phase I dose escalation study of 211At-MABG in adults with advanced pheochromocytoma \u002F paraganglioma (PPGL) or other NET-overexpressing cancers (as evidenced by positive MIBG imaging) who are refractory to, lacking, or ineligible for approved treatments. Phase 1 dose-escalation will follow a standard 3+3 design with an expansion cohort at the recommended phase two dose (RP2D).",[25,26,27,28,29,30],"Pheochromocytoma","Paraganglioma","Neuroendocrine Tumors","Medullary Thyroid Cancer","Bronchial Carcinoid","Gastroenteropancreatic Neuroendocrine Neoplasm","NOT_YET_RECRUITING","2026-06-16",{"date":34,"type":35},"2026-06-22","ACTUAL",{"date":37,"type":19},"2026-08-01",{"date":39,"type":19},"2032-08-01",{"name":41,"class":42},"University of Pennsylvania","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":15,"minAge":52,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":20,"phases":55,"briefSummary":57,"conditions":58,"keywords":79,"overallStatus":103,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":43},"100562786","phase-1-study-in-children-and-adolescents-of-177lu-dotatate-lutathera-combined-with-the-parp-inhibitor-olaparib-for-the-treatment-of-recurrent-or-relapsed-solid-tumours-expressing-somatostatin-receptor-sstr-luparped-100562786","NCT06607692","Study in Children and Adolescents of 177Lu-DOTATATE (Lutathera®) Combined With the PARP Inhibitor Olaparib for the Treatment of Recurrent or Relapsed Solid Tumours Expressing Somatostatin Receptor (SSTR) (LuPARPed).","Single-arm Open-label Phase I\u002FII Study in Children and Adolescents of 177Lu-DOTATATE (Lutathera®) Combined With the PARP Inhibitor Olaparib for the Treatment of Recurrent or Relapsed Solid Tumours Expressing Somatostatin Receptor (SSTR) (LuPARPed).","LUPARPED","Inclusion criteria:\n\n* 18 months - 18 years of age at the time of the initial diagnosis.\n* ≥ 3 years at the moment of inclusion in the trial.\n* Diagnosis: relapsed\u002Frefractory solid tumours with positive uptake on SSTR-PET (PET-CT or PET-MRI), performed in the previous three months before entering the study.\n\nThe evaluation of SSTR expression will be classified according to a qualitative 4-point scale: SSTR expression V (visual score):\n\n* Score = 0: Below or equal to blood pool\n* Score = 1: Above blood pool and lower than liver\n* Score = 2: Equal to or above liver and lower than spleen\n* Score = 3: Equal to or above spleen\n\nPatients with scores ≥ 2 in the majority of the tumoral lesions will be considered to have a positive SSTR-PET and will be therefore eligible for the trial. Patients with a higher score are presumed to have a better response to the treatment.\n\nIt is admissible to have non-measurable disease only (e.g., HR-NB with bone-only or bone-marrow-only active disease).\n\n* Performance status ≥ 50% according to Lansky scale (\\\u003C16 years old) or Karnofsky scale (for ≥16 years old).\n* Life expectancy of at least 3 months.\n* Availability of ability to swallow tablets or capsules.\n* Adequate organ function within 28 days prior to enrolment, as defined by:\n\n  * Hb ≥10 g\u002Fdl (packed red blood transfusion is acceptable up to 24 hours prior starting treatment);\n  * White blood cell (WBC) count ≥ 2500\u002FμL (equivalent to 2.5 x 109\u002FL)\n  * Absolute Neutrophil Count (ANC) ≥ 1000\u002Fμl;\n  * Platelets ≥ 100.000\u002Fμl, without transfusion in the prior ≥7 days;\n  * Serum plasma creatinine ≤ 1.5 x upper limit of normal (ULN) OR estimated glomerular filtration rate (eGFR) ≥ 60 mL\u002Fmin\u002F1.73m2 (assessed by 2009-Schwartz formula).\n  * Total bilirubin ≤ 1.5 x the institutional ULN. For patients with known Gilbert's Syndrome ≤ 3.0 ULN is permitted.\n  * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 3.0 ULN.\n  * Albumin \\>3.0 g\u002FdL (3.0 g\u002FdL is equivalent to 30 g\u002FL)\n* A negative serum or urine pregnancy test in women with onset of menses or ≥12 years of age.\n* Patients of reproductive potential must agree to use highly effective contraceptive methods for the entire study duration and up to 7 months, in case of females, and 4 months in case of males, after the last dose of Lutathera, or up to 6 months, in case of females, and 3 months in case of males, after the last dose of olaparib, whichever takes places later.\n* Have the ability to comprehend and willingness to provide written informed consent (ICF) for the study before patient registration or any trial-related screening procedures. If the patient is \\\u003C18 years old, the written informed consent must be signed by the parent(s) or legal guardian(s) according to national regulations. In the case of patients between 12 and 17 years, they must sign an assent form, and if the patient turns 18 during their participation in the study, they must sign an informed consent form.\n* Adequate recovery from major surgery prior to receiving study treatment.\n* Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.\n\nExclusion criteria\n\n* Previous significant drug-induced hepatitis toxicity experienced in the past that has required treatment dose reductions, treatment discontinuation or that, at the investigator discretion, could infer a risk.\n* Having received more than one previous treatment with other radiolabelled somatostatin analogues.\n* Inability to swallow tablets or capsules.\n* Subjects who are currently receiving any other anticancer and\u002For investigational agents (e.g. chemotherapy, immunotherapy or biological therapy \\[including monoclonal antibodies\\]). There must be at least 28 days of washout from any prior treatment. In case of checkpoints inhibitors, there should be at least 4 months of washout. Palliative Radiation Therapy for symptom control (e.g. pain relief) could be acceptable, at the discretion of the investigator.\n* Treatment with long-acting somatostatin analogues within 28 days prior the administration of 177Lu-DOTATATE.\n* Known hypersensitivity to any of the excipients.\n* Subjects who have an uncontrolled infection.\n* Lactating women.","3 Years",{"count":54,"type":19},25,[22,56],"PHASE2","Study in children and adolescents of 177Lu DOTATATE (Lutathera®) combined with the PARP inhibitor olaparib for treatment of recurrent or relapsed solid tumours expressing somatostatin receptors (SSTR) (LuPARPed)",[59,60,61,62,63,26,25,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78],"Solid Tumor Cancer","Medulloblastoma","High Risk Neuroblastoma","High Grade Gliomas","Meningioma","Neuroendocrine Tumours (NET)","Adrenal Tumours","DIPG","Glioblastoma","Glioblastoma (GBM)","Osteosarcoma Recurrent","Carcinoma Adrenal","Synovial Sarcomas","Esthesioneuroblastoma","Neuroblastoma Recurrent","Solid Tumor Refractory to Conventional Treatment","Medulloblastoma Recurrent","Paraganglioma\u002F Phaeochromocytoma","Ependymoma","Ependymoma Recurrent",[80,81,82,83,84,85,86,87,88,89,90,91,92,66,93,94,95,96,97,98,99,100,101,77,102],"solid tumours","somatostatin receptors","SSTR","LUTETIUM","OLAPARIB","MEDULLOBLASTOMA","NEUROBLASTOMA","HIGH GRADE GLIOMA","MEININGIOMA","PARAGANGLIOMA","PHEOCHROMOCYTOMA","NEUROENDOCRINE TUMOURS","ADRENAL TUMOR","GLIOBLASTOMA","OSTEOSARCOMA","CARCINOMA ADRENAL","SYNOVIAL SARCOMA","ESTHESIONEUROBLASTOMA","RECURRENT","RELAPSED","RELAPSE","REFRACTORY","Ependimoma Recurrent","RECRUITING","2026-06-02",{"date":106,"type":35},"2026-06-04",{"date":108,"type":35},"2024-09-20",{"date":110,"type":19},"2029-12",{"name":112,"class":42},"Fundación de investigación HM",{"id":114,"slug":115,"hasResults":11,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":4,"eligibilityCriteria":119,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":120,"enrollmentInfo":121,"targetDuration":4,"studyType":20,"phases":123,"briefSummary":124,"conditions":125,"keywords":130,"overallStatus":103,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":151},"100488169","phase-1-targeted-alpha-particle-therapy-for-advanced-somatostatin-receptor-type-2-sstr2-positive-tumors-100488169","NCT05636618","Targeted Alpha-Particle Therapy for Advanced Somatostatin Receptor Type 2 (SSTR2) Positive Tumors","A Phase I\u002FIIa First-in-Human Study of [212Pb]VMT-α-NET Targeted Alpha-Particle Therapy for Advanced SSTR2 Positive Tumors","Inclusion Criteria:\n\n1. Adult (ages ≥18) PRRT-naïve subjects with NETs or meningioma by local pathology.\n2. Disease described clinically as: (a) Locally advanced\u002Funresectable or metastatic NETs for dose-finding part of the study (b) Locally advanced\u002Funresectable or metastatic GEP-NETs, bronchial NETs, pheochromocytoma, or paragangliomas for the dose-expansion part of the study (c) Requiring at least 1 prior surgery (resection\u002Fbiopsy) and a maximum of 1 line of EBRT, if technically feasible, for meningioma.\n3. For meningioma: histologically confirmed diagnosis of meningioma, i.e., all grades (1 to 3) per World Health Organization Classification of Tumors of the Central Nervous System (5th edition; WHO-CNS5)\n4. Radiological evidence of measurable disease by: (a) For NETs: RECIST v1.1 criteria on CT with contrast or MRI of the areas of tumor involvement within 60 days of enrollment.\n5. Lesions must have shown radiological evidence of disease progression in the 12 months prior to enrollment. (b) For meningioma: RANO meningioma criteria on contrast-enhanced skull MRI for meningioma within 3 weeks prior to enrollment.\n6. Demonstration of lesional SSTR expression: (a) For NETs: using an FDA-approved somatostatin receptor PET imaging agent, e.g. \\[68Ga\\]DOTATATE, \\[64Cu\\]DOTATATE, or \\[68Ga\\]DOTATOC (b) For meningioma: using a standard-of-care SSTR PET imaging agent within 45 days of enrollment\n7. ECOG Performance Status ≤ 1.\n8. Subjects with HIV positivity are allowed if CD4 Count \\> 350 cells\u002FμL.\n9. Concurrent Somatostatin Analog (SSA) Therapy use while on protocol therapy is allowed provided that the subject must be able to tolerate withholding long-acting SSA therapy for a minimum of 28 days and short-acting SSA therapy for a minimum of 24 hours before the first and subsequent administrations of \\[203Pb\\]VMT-α-NET or \\[212Pb\\]VMT-α-NET\n10. For NETs: Progressive Disease on approved therapies other than radionuclide therapy.\n11. For subjects with meningioma who are receiving corticosteroid treatment, the dose must be ≤ 4 mg\u002Fday dexamethasone (or other corticosteroid equivalent dose) for a minimum of 7 days before the initiation of study treatment.\n12. Must have clinically demonstrated adequate catecholamine blockade if catecholamine-secreting pheochromocytoma\u002Fparaganglioma tumors are present.\n13. Able to understand and sign informed consent and comply with all study requirements.\n14. Life expectancy \\> 3 months.\n15. Satisfactory organ function as determined by laboratory testing.\n16. For females of reproductive potential: agree to use of highly effective contraception and refrain from donating eggs (ova, oocytes) for the purpose of reproduction starting from screening, during treatment, and for at least 6 months after the last dose of \\[212Pb\\]VMT-α-NET\n17. For males of reproductive potential: agree to use of condoms or other methods to ensure effective contraception with partner and refrain from donating sperm starting from screening, during treatment, and for at least 6 months after the last dose of \\[212Pb\\]VMT-α-NET\n\nExclusion Criteria:\n\n1. Known hypersensitivity to SSA, SSTR imaging agents or any of the excipients of \\[212Pb\\]VMT-α-NET.\n2. Known additional malignancy that is progressing or requires active treatment.\n3. Pregnancy or breastfeeding a child.\n4. Febrile illness within 48 hours of any scheduled \\[212Pb\\]VMT-α-NET administration should be rescheduled \\> 48 hours after resolution of fever\\].\n5. Treatment with another investigational medicinal product within 30 days of anticipated treatment.\n6. Prior treatment with systemic PRRT based therapies (i.e., \\[90Y\\] DOTATATE\u002FDOTATOC or \\[177Lu\\] DOTATATE)\n7. Prior treatment with 90-Yttrium radioembolization must be completed at least 6 months prior to enrollment.\n8. External beam radiation therapy (EBRT) must be completed at least 30 days prior to enrollment.\n9. Subjects who have received prior treatment with 90Y radioembolization or EBRT should have radiation absorbed dose to critical organs documented.\n10. Prior treatment with systemic anticancer therapy must be completed at least 30 days prior to enrollment (except for SSAs in subjects with functional tumors).\n11. Major surgery must be completed at least 30 days prior to enrollment.\n12. For Subjects with NETs: Known brain metastases; unless these metastases have been treated and stabilized 6 months prior to enrollment and the subject has been off steroid support for at least 14 days prior to enrollment.\n13. Recently diagnosed and active infections requiring a time-limited course of antifungals or antibiotics in the 3 days prior to enrollment.\n14. Receipt of live attenuated vaccines in the 7 days prior to enrollment.\n15. Grade 3 nausea\u002Fvomiting or diarrhea within 72 hours before the of first scheduled dose of \\[212Pb\\]VMT-α-NET despite adequate antiemetic and other supportive care\n16. Known medical condition which would make this protocol unreasonably hazardous for the subject.\n17. Medical history of a condition resulting in a severe allergic reaction such as anaphylaxis or angioedema to known components of the Investigational Medicinal Product or excipients.\n18. Current abuse of alcohol or illicit drugs (exclusive of use of medically prescribed cannabinoids).\n19. Existence of any medical or social issues likely to interfere with study conduct or that may cause increased risk to the subject or to others, e.g., lack of ability to follow radiation safety precautions.\n20. QTc \\> 450 milliseconds for males and females.","90 Years",{"count":122,"type":19},300,[22,56],"This study is Phase I\u002FIIa First-in-Human Study of \\[212Pb\\]VMT-α-NET Targeted Alpha-Particle Therapy for Advanced SSTR2 Positive Tumors",[126,127,128,129,26,25,63],"Neuroendocrine Tumors Unresectable","Neuroendocrine Tumor Metastatic","Gastroenteropancreatic Neuroendocrine Tumor","Bronchial Neuroendocrine Tumor",[131,132,27,133,134,135,136,137,138,139,140,63],"Radiopharmaceuticals","Somatostatin Receptor Type 2 (SSTR2)","Metastatic Neuroendocrine Tumors","Pb-212","Theranostics","Alpha Particle Therapy","Radiotherapy","[212Pb]VMT-α-NET","VMT-α-NET-T01","Pb-203","2026-05-13",{"date":143,"type":35},"2026-05-14",{"date":145,"type":35},"2023-09-27",{"date":147,"type":19},"2029-12-26",{"name":149,"class":150},"Perspective Therapeutics","INDUSTRY",19,{"id":153,"slug":154,"hasResults":11,"nctId":155,"briefTitle":156,"officialTitle":156,"acronym":4,"eligibilityCriteria":157,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":158,"enrollmentInfo":159,"targetDuration":4,"studyType":20,"phases":161,"briefSummary":162,"conditions":163,"keywords":165,"overallStatus":103,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":43},"100301589","phase-2-lu-177-dotatate-lutathera-in-therapy-of-inoperable-pheochromocytoma-paraganglioma-100301589","NCT03206060","Lu-177-DOTATATE (Lutathera) in Therapy of Inoperable Pheochromocytoma\u002F Paraganglioma","* INCLUSION CRITERIA:\n* Surgically inoperable participants with clinical diagnosis of PHEO\u002FPGL who also have demonstrated disease histologically consistent with pheochromocytoma or paraganglioma (preferably confirmed by research site pathology review if initial pathology was done outside of research site, but not mandatory)\n* Progressive disease by RECIST 1.1 with or without symptoms within the last 12 months. NOTE: Untreated participants with existing histologic diagnoses are eligible if progression can be demonstrated\n* PHEO\u002FPGL that is not associated with any known susceptibility genetic mutations for PHEO\u002FPGL except SDHx mutation (a.k.a. \"apparent sporadic\"), based on documented genetic testing results obtained prior to study enrollment. PHEO\u002FPGL that is associated with non-SDHx mutations such as VHL, NF1, and RET will not be eligible for this study.\n* Both metastatic and inoperable primary-only participants are eligible.\n* Must have presence of SSTR+ disease as documented by positive Ga-68-DOTATATE PET scan within 12 weeks of anticipated treatment.\n\nNOTE:\n\n* Positivity of Ga-68-DOTATATE PET scan defined as having at least one lesion that is greater than or equal to 10 mm in diameter with uptake that is higher than or equal to liver and is qualitatively higher and distinguishable from background activity.\n* Measurable disease as defined by RECIST 1.1.\n\n  * Age greater than or equal to 18\n  * Karnofsky Performance Score greater than or equal to 60 or ECOG Performance Status of 2 or better.\n  * Able to understand and willing to sign informed consent.\n  * Ability and willingness to obtain all required scans per study schedule.\n  * Negative serum pregnancy test for women of child-bearing potential. NOTE: A female is not of childbearing potential if a prior history of hysterectomy with bilateral oophorectomy or other procedure has rendered the participant surgically sterile, or \\>2 years since last menstruation.\n  * Female participants of childbearing potential and male participants who are not surgically sterile or with female partners of childbearing potential must agree to use effective, non-hormonal means of contraception (intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal gel) prior to study entry, for the duration of study participation, and for 4 months for male participants or 7 months for female participants (10 half-lives of Lu-177) after the last dose of Lu-177-DOTATATE.\n  * Must have outside endocrinologist\u002Fmedical oncologist who can follow the participant after receiving PRRT (NIH only requirement).\n  * Patients with secreting tumors must be receiving adequate pharmacologic catecholamine blockade as determined by the treating physician.\n  * Ineligible, unable to or unwilling to receive standard first line therapy for PHEO\u002FPGL.\n\nEXCLUSION CRITERIA:\n\n* Creatinine clearance \\\u003C50 mL\u002Fmin calculated by the MDRD method, eventually confirmed by measured creatinine clearance (or measured glomerular filtration rate (GFR) using plasma clearance methods.\n* Serum albumin less than or equal to 3.0 g\u002FdL unless prothrombin time is within the normal range.\n* Liver dysfunction as evidenced by Child s Class C Liver Disease or worse Alternatively, AST or ALT \\> 2.5 times institutional upper limit of normal (ULN) unless liver metastases are present, in which case up to 5 times ULN would be allowed.\n* Hb \\\u003C 8.0 g\u002FdL; WBC \\\u003C 2.0 x 10\\^9\u002FL (or Absolute Neutrophil Count \\\u003C 1000); Platelets \\\u003C 100 x 10\\^9\u002FL\n* In participants with symptoms of congestive heart failure, New York Heart Association (NYHA) classification of grade III or IV\n* Pregnancy or lactation.\n* Prior anti-tumoral radionuclide therapy with unsealed sources. Prior therapy with sealed radioactive sources such as brachytherapy will be allowed.\n* Prior local radiation therapy would be allowed as long as there is at least one non-irradiated index lesion.\n* Known brain metastases, unless these metastases have been treated and stabilized for at least 24 weeks, prior to enrollment in the study. Patients with a history of brain metastases must have a head CT or MRI scan with contrast to document stable disease for at least 24 weeks prior to enrolment in the study.\n* Other known co-existing malignancies except non-melanoma skin cancer and carcinoma in situ of the uterine cervix, unless definitively treated and proven no evidence of recurrence for 5 years.\n* Patients who participated in any therapeutic clinical study with an investigational agent within the last 30 days.\n* Patients may be on somatostatin analogue therapy (e.g. but not only limited to sandostatin or lanreotide therapy). However, therapy with somatostatin analogues should not be initiated or altered within 3 months of study enrolment. Patients on short term octreotide may have dose held for 24 hours prior to Lu-177-DOTATATE therapy. Those on long acting octreotide therapy will receive treatment at 1 to 5 days prior to their next cold octreotide dose, in order to prevent competition for the receptor.\n* Patient weight \\> 400 lbs (table limit for PET scanner) or per local institutional standard for participating sites.\n* Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, hypertension (\\>180\u002F110), arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Inability to tolerate at least one modality of diagnostic anatomic imaging, such as CT or MRI.","100 Years",{"count":160,"type":19},130,[56],"Background:\n\nPheochromocytoma and paraganglioma are rare tumors. They usually form inside and near the adrenal gland or in the neck region. Not all these tumors can be removed with surgery, and there are no good treatments if the disease has spread. Researchers think a new drug may be able to help.\n\nObjective:\n\nTo learn the safety and tolerability of Lu-177-DOTATATE. Also, to see if it improves the length of time it takes for the cancer to return.\n\nEligibility:\n\nAdults who have an inoperable tumor of the study cancer that can be detected with Ga-68-DOTATATE PET\u002FCT imaging\n\nDesign:\n\nParticipants will be screened with a medical history, physical exam, and blood tests.\n\nEligible participants will be admitted to the NIH Clinical Center.\n\nParticipants will get the study drug in an intravenous infusion. They will get 4 doses, given about 8 weeks apart.\n\nBetween 4 and 24 hours after each study drug dose, participants will have scans taken. They will lie on their back on a scanner table.\n\nParticipants will have vital signs taken. They will give blood and urine samples.\n\nDuring the study, participants will have other scans taken. Some scans will use a radioactive tracer.\n\nParticipants will complete quality of life questionnaires.\n\nParticipants will be contacted by phone 1-3 days after they leave the Clinical Center. They will then be followed every 3 to 6 months for 3 years or until their disease gets worse.",[25,26,27,164],"Neuroendocrine Neoplasms",[166,167,168,169,170],"Hypertension","Catecholamine","Familial Syndromes","Somatostatin Receptors","Ionizing Radiation","2026-04-23",{"date":173,"type":35},"2026-04-24",{"date":175,"type":35},"2017-10-10",{"date":177,"type":19},"2033-01-01",{"name":179,"class":180},"National Cancer Institute (NCI)","NIH",{"id":182,"slug":183,"hasResults":11,"nctId":184,"briefTitle":185,"officialTitle":186,"acronym":4,"eligibilityCriteria":187,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":188,"enrollmentInfo":189,"targetDuration":191,"studyType":192,"phases":4,"briefSummary":193,"conditions":194,"keywords":197,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":203,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":4},"100632637","prospective-cohort-study-of-pheochromocytomaparaganglioma-100632637","NCT07516275","Prospective Cohort Study of Pheochromocytoma\u002FParaganglioma","Validation and Extension Study of the Predictive Model for Intraoperative Hemodynamic Instability in Pheochromocytoma\u002FParaganglioma Resection - a Single-center, Prospective, Observational Cohort Study","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Diagnosed with pheochromocytoma\u002Fparaganglioma by imaging and laboratory tests and scheduled for elective resection.\n* Planned intraoperative continuous invasive arterial pressure monitoring.\n* Willing and able to provide written informed consent.\n* Able to comply with preoperative CGM monitoring, AI agent assessment, and postoperative follow-up.\n\nExclusion Criteria:\n\n* Intraoperative hemodynamic data missing ≥20%.\n* Postoperative histopathology excludes PPGL diagnosis.\n* Cardiac paraganglioma or metastatic PPGL.\n* Severe cardiac disease (e.g., severe valvular disease, severe heart failure) that could independently cause intraoperative HDI.\n* Pregnancy or breastfeeding.\n* Mental illness, cognitive impairment, or communication barriers that prevent compliance with study procedures.\n* Refusal to undergo CGM monitoring or AI agent assessment.\n* Major illness (e.g., acute myocardial infarction, stroke, severe infection) within 3 months prior to surgery.\n* Severe hepatic or renal insufficiency (Child-Pugh class C, eGFR \\\u003C30 ml\u002Fmin\u002F1.73 m²).","99 Years",{"count":190,"type":19},200,"6 Weeks","OBSERVATIONAL","The study will enroll patients scheduled for PPGL removal surgery at Peking Union Medical College Hospital. Before surgery, researchers will use a 6-variable model to predict the patient's risk of experiencing severe blood pressure swings during the operation. During surgery, a real-time early warning tool will be tested for its ability to accurately predict blood pressure changes 60 seconds in advance. The study will also explore the value of continuous glucose monitoring (CGM) in understanding blood pressure fluctuations and evaluate the performance of an artificial intelligence (AI) agent for preoperative anesthesia assessment, comparing its accuracy, consistency, and efficiency against that of human anesthesiologists.\n\nParticipation involves no changes to the patient's standard surgical or medical care. It includes collecting clinical data, wearing a CGM sensor from the day before to the day after surgery, and having the preoperative assessment performed by both the AI agent and anesthesiologists.",[25,26,195,196],"Hemodynamic Instability","Intraoperative Complications",[25,26,195,198,199,200,201],"Predictive Model","Artificial Intelligence","Continuous Glucose Monitoring","Prospective Cohort","2026-04-02",{"date":204,"type":35},"2026-04-07",{"date":206,"type":19},"2026-04",{"date":208,"type":19},"2028-02",{"name":210,"class":42},"Peking Union Medical College Hospital",{"id":212,"slug":213,"hasResults":11,"nctId":214,"briefTitle":215,"officialTitle":216,"acronym":4,"eligibilityCriteria":217,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":218,"enrollmentInfo":219,"targetDuration":4,"studyType":20,"phases":221,"briefSummary":222,"conditions":223,"keywords":4,"overallStatus":103,"whyStopped":4,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":239,"startDateStruct":241,"completionDateStruct":243,"leadSponsor":245,"locationsCount":247},"100371641","phase-1-gene-modified-immune-cells-after-conditioning-regimen-for-the-treatment-of-stage-iiic-or-iv-melanoma-or-metastatic-solid-tumors-100371641","NCT04119024","Gene Modified Immune Cells After Conditioning Regimen for the Treatment of Stage IIIC or IV Melanoma or Metastatic Solid Tumors","Phase I Dose Escalation Study of Systemically Administered IL13Ra2 Chimeric Antigen Receptor (CAR) T Cells After a Nonmyeloablative Conditioning Regimen in Patients With Metastatic Melanoma and Other Solid Tumors","Inclusion Criteria:\n\n* Histologically confirmed malignancy that is considered surgically incurable with either:\n\n  * Stage IIIC melanoma including locally relapsed, satellite, in-transit lesions or bulky draining node metastasis\n  * Stage IV melanoma including patients with known brain metastases\n  * Other metastatic, non-central nervous system (CNS) solid tumor relapsed or refractory after all standard-of-care systemic therapies for which the patient is eligible\n* Confirmed IL13Ralpha2 tumor expression by immunohistochemistry (immunohistochemical assay \\[IHA\\] H-Score \\>= 50 in at least 10% of the total tumor specimen and in at least two high-power fields)\n* Age greater than or equal to 18 years old and less than 75 years old\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n* A minimum of one measurable lesion defined as:\n\n  * Meeting the criteria for measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST), OR\n  * Skin lesion(s) selected as non-completely biopsied target lesion(s) that can be accurately measured and recorded by color photography with a ruler to document the size of the target lesion(s)\n* Absolute neutrophil count (ANC) \\>= 1 x 10\\^9 cells\u002FL (determined within 30-60 days prior to enrollment; re-evaluated within 14 days of beginning conditioning chemotherapy)\n* Platelets \\>= 75 x 10\\^9\u002FL (determined within 30-60 days prior to enrollment; re-evaluated within 14 days of beginning conditioning chemotherapy)\n* Hemoglobin \\>= 9.5 g\u002FdL (determined within 30-60 days prior to enrollment; re-evaluated within 14 days of beginning conditioning chemotherapy)\n* Aspartate and alanine aminotransferases (AST, ALT) =\\\u003C 2.5 x upper limit of normal (ULN) (determined within 30-60 days prior to enrollment; re-evaluated within 14 days of beginning conditioning chemotherapy)\n* Total bilirubin =\\\u003C 2 x ULN (except patients with documented Gilbert's syndrome) (determined within 30-60 days prior to enrollment; re-evaluated within 14 days of beginning conditioning chemotherapy)\n* Creatinine \\\u003C 2 mg\u002FdL (or a glomerular filtration rate \\> 45) (determined within 30-60 days prior to enrollment; re-evaluated within 14 days of beginning conditioning chemotherapy)\n* Patients with melanoma must have progressed following \\>= 1 line of systemic therapy, including immune checkpoint inhibitor and a BRAF inhibitor in combination with MEK inhibitor for patients with BRAF V600-activating mutation and is not considered to have an alternate treatment option with curative intent\n* Must be willing and able to accept at least one leukapheresis procedure (This does not apply for patients receiving a second infusion of IL13R a2 CAR T cells as they will not undergo leukapheresis)\n* Must be willing and able to provide written informed consent\n\nExclusion Criteria:\n\n* Inability to purify \\>= 1 x 10\\^7 T cells from leukapheresis product (this does not apply to patients receiving a second infusion of IL13Ra2 CAR T cells as they will not undergo leukapheresis)\n* Previously known hypersensitivity to any of the agents used in this study; known sensitivity to cyclophosphamide or fludarabine\n* Received systemic treatment for cancer, including immunotherapy, within 14 days prior to initiation of conditioning chemotherapy administration within this protocol\n* Clinically active brain metastases. Radiological documentation of absence of active brain metastases at screening is required for all patients. Prior evidence of brain metastasis successfully treated with surgery or radiation therapy will not be exclusion for participation as long as they are deemed under control at the time of study enrollment\n* Potential requirement for systemic corticosteroids or concurrent immunosuppressive drugs based on prior history or received systemic steroids within the last 2 weeks prior to enrollment; not including patients with primary or secondary adrenal insufficiency who require physiologic replacement with steroids, or patients on inhaled or topical steroids at standard doses\n* Human immunodeficiency virus (HIV) seropositivity or other congenital or acquired immune deficiency state, which would increase the risk of opportunistic infections and other complications during chemotherapy-induced lymphodepletion. If there is a positive result in the infectious disease testing that was not previously known, the patient will be referred to their primary physician and\u002For infectious disease specialist\n* Hepatitis B or C seropositivity with evidence of ongoing liver damage, which would increase the likelihood of hepatic toxicities from the chemotherapy conditioning regimen and supportive treatments. If there is a positive result in the infectious disease testing that was not previously known, the patient will be referred to their primary physician and\u002For infectious disease specialist\n* Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol\n* A Tiffeneau-Pinelli index \\\u003C 70% of the predicted value. Subjects will be excluded if pulmonary function tests indicate they have insufficient pulmonary capability\n* Patients will be excluded if they have a history of clinically significant electrocardiography (ECG) abnormalities, symptoms of cardiac ischemia or arrhythmias and have a left ventricular ejection fraction (LVEF) \\\u003C 45% on a cardiac stress test (stress thallium, stress multigated acquisition scan (MUGA), dobutamine echocardiogram, or other stress test)\n* Patients with ECG results of any conduction delays (PR interval \\> 200 ms, corrected QT (QTC) \\> 480 ms), sinus bradycardia (resting heart rate \\\u003C 50 beats per minute), sinus tachycardia (HR \\> 120 beats per minute) will be evaluated by a cardiologist prior to starting the trial. Patients with any arrhythmias, including atrial fibrillation\u002Fatrial flutter, excessive ectopy (defined as \\> 20 ventricular premature complex \\[PVC\\]s per minute), ventricular tachycardia, 3rd degree heart block will be excluded from the study unless cleared by a cardiologist\n* Pregnancy or breast-feeding. Female patients must be surgically sterile or be postmenopausal for two years, or must agree to use effective contraception during the period of treatment and for 6 months afterwards. All female patients with reproductive potential must have a negative pregnancy test (serum\u002Furine) at screening and again within 14 days from starting the conditioning chemotherapy. The definition of effective contraception will be based on the judgment of the study investigators. Patients who are breastfeeding are not allowed on this study\n* A concomitant active malignancy that would be considered to interfere with the assessment of the primary or secondary endpoints of the study","75 Years",{"count":220,"type":19},18,[22],"This phase I trial studies the side effects and best dose of modified immune cells (IL13Ralpha2 CAR T cells) after a chemotherapy conditioning regimen for the treatment of patients with stage IIIC or IV melanoma or solid tumors that have spread to other places in the body (metastatic). The study agent is called IL13Ralpha2 CAR T cells. T cells are a special type of white blood cell (immune cells) that have the ability to kill tumor cells. The T cells are obtained from the patient's own blood, grown in a laboratory, and modified by adding the IL13Ralpha2 CAR gene. The IL13Ralpha2 CAR gene is inserted into T cells with a virus called a lentivirus. The lentivirus allows cells to make the IL13Ralpha2 CAR protein. This CAR has been designed to bind to a protein on the surface of tumor cells called IL13Ralpha2. This study is being done to determine the dose at which the gene-modified immune cells are safe, how long the cells stay in the body, and if the cells are able to attack the cancer.",[224,225,226,227,228,229,230,231,27,26,25,232,233,234,235,236,237],"Metastatic Malignant Solid Neoplasm","Metastatic Melanoma","Pathologic Stage IIIC Cutaneous Melanoma AJCC v8","Pathologic Stage IV Cutaneous Melanoma AJCC v8","Recurrent Malignant Solid Neoplasm","Refractory Malignant Solid Neoplasm","Uveal Melanoma","Acral Melanoma","Adrenocortical Carcinoma","Pancreatic Neuroendocrine Tumor","Thyroid Cancer","Breast Cancer","Lung Adenocarcinoma","Head and Neck Squamous Cell Carcinoma","2026-03-13",{"date":240,"type":35},"2026-03-17",{"date":242,"type":35},"2025-10-07",{"date":244,"type":19},"2026-10",{"name":246,"class":42},"Anusha Kalbasi",3,{"id":249,"slug":250,"hasResults":11,"nctId":251,"briefTitle":252,"officialTitle":253,"acronym":4,"eligibilityCriteria":254,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":255,"targetDuration":4,"studyType":20,"phases":257,"briefSummary":259,"conditions":260,"keywords":4,"overallStatus":103,"whyStopped":4,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":262,"startDateStruct":264,"completionDateStruct":266,"leadSponsor":268,"locationsCount":43},"100488163","early-phase-1-in-vivo-parp-1-expression-with-18f-fluorthanatrace-petct-in-patients-with-pheochromocytoma-and-paraganglioma-100488163","NCT05636540","In Vivo PARP-1 Expression With 18F-FluorThanatrace PET\u002FCT in Patients With Pheochromocytoma and Paraganglioma","Evaluating in Vivo PARP-1 Expression With 18F-FluorThanatrace Positron Emission Tomography (PET\u002FCT) in Patients With Pheochromocytoma and Paraganglioma","Inclusion Criteria:\n\n1. Participants will be ≥ 18 years of age.\n2. Clinical diagnosis of pheochromocytoma or paraganglioma based on biochemical and imaging studies At least one lesion identified on standard of care imaging (e.g. CT, MRI, FDG or 68-Gallium dotatate, other PET\u002FCT or MIBG).\n3. Standard of care germline genetic testing performed for clinical purposes or participant's consent for germline genetic testing for research purposes.\n4. Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures.\n\nExclusion Criteria:\n\n1. Inability to tolerate imaging procedures in the opinion of an investigator or treating physician.\n2. Females who are pregnant or breastfeeding will not be eligible for this study; a urine pregnancy test will be performed in women of child-bearing potential prior to FTT injection.\n3. Any current medical condition, illness, or disorder as assessed by medical record review and\u002For self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study.",{"count":256,"type":19},30,[258],"EARLY_PHASE1","This study will enroll up to 30 evaluable patients with pheochromocytoma or paraganglioma who are undergoing surgical or systemic treatment.\n\nA pre-treatment 18F-FluorThanatrace (\\[18F\\]FTT) positron emission tomography\u002Fcomputed tomography (PET\u002FCT) scan will be done prior to surgery or systemic therapy.\n\nPET\u002FCT imaging will be used to evaluate PARP-1 expression in sites of pheochromocytoma or paraganglioma using the investigational radiotracer \\[18F\\]FTT. This is an observational study in that \\[18F\\]FTT PET\u002FCT will not be used to direct treatment decisions. While patients and referring physicians will not be blinded to the \\[18F\\]FTT PET\u002FCT results, treatment decisions will be made by the treating physicians based upon clinical criteria.",[25,26],"2026-02-26",{"date":263,"type":35},"2026-02-27",{"date":265,"type":35},"2023-07-01",{"date":267,"type":19},"2026-12-31",{"name":269,"class":42},"Heather Wachtel",{"id":271,"slug":272,"hasResults":11,"nctId":273,"briefTitle":274,"officialTitle":275,"acronym":4,"eligibilityCriteria":276,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":277,"targetDuration":279,"studyType":192,"phases":4,"briefSummary":280,"conditions":281,"keywords":306,"overallStatus":103,"whyStopped":4,"lastUpdateSubmitDate":312,"lastUpdatePostDateStruct":313,"startDateStruct":315,"completionDateStruct":317,"leadSponsor":319,"locationsCount":43},"100560175","institutional-registry-of-rare-diseases-100560175","NCT06573723","Institutional Registry of Rare Diseases","Institutional Registries of Rare Diseases at Hospital Italiano de Buenos Aires (HIBA)","Inclusion Criteria:\n\n* Clinical and\u002For molecular diagnosis of any of the following rare diseases: Amyloidosis, Sarcoidosis, Phacomatosis, Pheochromocytoma, Paraganglioma, Von Hippel-Lindau Disease, Immunoglobulin G4-Related Disease, Demyelinating Diseases, Inborn Errors of Metabolism, Eosinophilic Gastrointestinal Disorders, Hypertrophic Cardiomyopathy, Gaucher Disease, Congenital Adrenal Hyperplasia, Hereditary Angioedema, Pulmonary Hypertension, Wilson Disease, Vascular Anomalies, Mastocytosis, Multiple Endocrine Neoplasia, Inflammatory Bowel Diseases, Prader-Willi Syndrome, Hirschsprung Disease, or Cushing Syndrome.\n* Must be followed at Hospital Italiano de Buenos Aires.\n\nExclusion Criteria:\n\n\\- Refusal to participate in the study or in the informed consent process.",{"count":278,"type":19},380,"10 Years","The goal of this observational study is to create a single macro registry system with data collection on common clinical features, grouping the different rare diseases (RD).\n\nMoreover, the specific goals are to generate an alert system for possible cases of RD with data from the electronic medical record, to describe the occurrence of RD in the evaluated population, to characterize the population, to describe patterns of diagnosis and treatment of RD present at the time, and to explore patient-reported outcomes.",[282,283,284,285,25,26,286,287,288,289,290,291,292,293,294,295,296,297,298,299,300,301,302,303,304,305],"Rare Diseases","Amyloidosis","Sarcoidosis","Phacomatosis","Von Hippel-Lindau Disease","Immunoglobulin G4-Related Disease","Demyelinating Diseases","Inborn Errors of Metabolism","Eosinophilic Gastrointestinal Disorders","Hypertrophic Cardiomyopathy","Gaucher Disease","Congenital Adrenal Hyperplasia","Hereditary Angioedema","Pulmonary Hypertension","Wilson Disease","Vascular Anomalies","Mastocytosis","Multiple Endocrine Neoplasia","Inflammatory Bowel Diseases","Prader-Willi Syndrome","Hirschsprung Disease","Cushing Syndrome","HHT","Hemorrhagic Hereditary Telangiectasia",[307,308,309,285,310,311,286,287,288,289,290,291,292,293,294,295,296,297,298,299,300,301,302,303,305],"rare diseases","amyloidosis","sarcoidosis","pheochromocytoma","paraganglioma","2026-01-12",{"date":314,"type":35},"2026-01-14",{"date":316,"type":35},"2024-07-01",{"date":318,"type":19},"2034-12-31",{"name":320,"class":42},"Hospital Italiano de Buenos Aires",{"id":322,"slug":323,"hasResults":11,"nctId":324,"briefTitle":325,"officialTitle":326,"acronym":327,"eligibilityCriteria":328,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":158,"enrollmentInfo":329,"targetDuration":4,"studyType":20,"phases":330,"briefSummary":332,"conditions":333,"keywords":4,"overallStatus":103,"whyStopped":4,"lastUpdateSubmitDate":337,"lastUpdatePostDateStruct":338,"startDateStruct":340,"completionDateStruct":342,"leadSponsor":344,"locationsCount":43},"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",{"count":190,"type":19},[331],"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.",[334,63,72,335,60,26,336],"CNS Tumors","Hemangioblastoma","Pituitary Adenoma","2025-11-17",{"date":339,"type":35},"2025-11-21",{"date":341,"type":35},"2019-09-04",{"date":343,"type":19},"2038-12-31",{"name":345,"class":42},"Weill Medical College of Cornell University",{"id":347,"slug":348,"hasResults":11,"nctId":349,"briefTitle":350,"officialTitle":350,"acronym":4,"eligibilityCriteria":351,"healthyVolunteers":352,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":353,"targetDuration":355,"studyType":192,"phases":4,"briefSummary":356,"conditions":357,"keywords":364,"overallStatus":103,"whyStopped":4,"lastUpdateSubmitDate":369,"lastUpdatePostDateStruct":370,"startDateStruct":372,"completionDateStruct":374,"leadSponsor":376,"locationsCount":43},"100298073","genetic-analysis-of-pheochromocytomas-paragangliomas-and-associated-conditions-100298073","NCT03160274","Genetic Analysis of Pheochromocytomas, Paragangliomas and Associated Conditions","Inclusion Criteria:\n\n* diagnosis of pheochromocytoma and or paraganglioma\n* family member with diagnosis of pheochromocytoma and or paraganglioma\n* diagnosis of a pheochromocytoma- and or paraganglioma-associated condition\n* family member with diagnosis of a pheochromocytoma- and or paraganglioma-associated condition\n\nExclusion Criteria:\n\n* unconfirmed diagnosis of pheochromocytoma and\u002For paraganglioma or associated condition",true,{"count":354,"type":19},2000,"30 Years","Pheochromocytomas and paragangliomas are neural crest-derived tumors of the nervous system that are often inherited and genetically heterogeneous. Genetic screening is recommended for patients and their relatives, and can guide clinical decisions. However, a mutation is not found in all cases. The aims of this proposal are to: 1) to map gene(s) involved in pheochromocytoma, and 2) identify genotype-phenotype correlations in patients with pheochromocytoma\u002Fparaganglioma of various genetic origins.",[25,26,358,359,360,361,362,363],"Inherited Cancer Syndrome","Associated Conditions","Kidney Neoplasms","Bone Cancer","Thyroid Neoplasms","Other Cancer",[365,366,367,368],"tumor suppressor gene","oncogene","mutation","susceptibility gene","2025-10-13",{"date":371,"type":35},"2025-10-15",{"date":373,"type":35},"2005-10-19",{"date":375,"type":19},"2030-12-31",{"name":377,"class":42},"The University of Texas Health Science Center at San Antonio",{"id":379,"slug":380,"hasResults":11,"nctId":381,"briefTitle":382,"officialTitle":383,"acronym":4,"eligibilityCriteria":384,"healthyVolunteers":11,"sex":15,"minAge":385,"maxAge":4,"enrollmentInfo":386,"targetDuration":385,"studyType":192,"phases":4,"briefSummary":387,"conditions":388,"keywords":390,"overallStatus":103,"whyStopped":4,"lastUpdateSubmitDate":395,"lastUpdatePostDateStruct":396,"startDateStruct":398,"completionDateStruct":400,"leadSponsor":402,"locationsCount":43},"100607972","clinical-application-of-somatostatin-receptor-and-norepinephrine-transporter-targeted-imaging-for-diagnosis-and-staging-of-neuroblastoma-and-pheochromocytomaparaganglioma-100607972","NCT07195500","Clinical Application of Somatostatin Receptor and Norepinephrine Transporter Targeted Imaging for Diagnosis and Staging of Neuroblastoma and Pheochromocytoma\u002FParaganglioma","the Clinical Application of Somatostatin Receptor and Norepinephrine Transporter Targeted Imaging for the Diagnosis and Staging of Neuroblastoma and Pheochromocytoma\u002FParaganglioma","Inclusion Criteria:\n\n* Age: ≥6 months (pediatric and adult).\n* Suspected or confirmed diagnosis of neuroblastoma (NB) or pheochromocytoma\u002Fparaganglioma (PPGL).\n* Clinical indication for SSTR and\u002For NET-targeted molecular imaging for initial staging, restaging, suspected recurrence, response assessment, or treatment planning.\n* Ability to undergo PET\u002FCT or PET\u002FMRI and\u002For SPECT\u002FCT per protocol; for the PET\u002FMRI subset, no MRI contraindications.\n* Provision of written informed consent\u002Fassent per local regulations.\n* Women of childbearing potential: negative pregnancy test within 72 hours prior to tracer administration and agreement to use effective contraception during the imaging window.\n* For the multi-tracer subset (if applicable): willingness to undergo two imaging studies within a predefined window (e.g., ≤28 days) without intervening antitumor therapy.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding; breastfeeding participants unwilling to follow tracer-specific lactation interruption guidance per institutional policy.\n* Any condition that, in the investigator's judgment, precludes safe imaging or protocol compliance (e.g., uncontrolled cardiorespiratory disease, severe claustrophobia not amenable to sedation\u002Fanxiolysis).\n* Known hypersensitivity to study radiopharmaceuticals or their excipients.\n* Use of interfering medications without feasible washout:\n\nNET imaging: drugs that affect catecholamine transport\u002Fstorage (e.g., labetalol, tricyclic antidepressants, certain sympathomimetics) per site SOPs.\n\nSSTR imaging: long-acting somatostatin analogues within \\~3-4 weeks or short-acting within \\~24-48 hours, unless clinically unavoidable.\n\n* Prior therapeutic or high-dose 131I-MIBG within a period that would confound diagnostic imaging or dosimetry (e.g., within 6 months), at the investigator's discretion.\n* Contraindications to required modality-specific procedures (e.g., MRI-incompatible implants for PET\u002FMRI; iodinated\u002Fgadolinium contrast contraindication only if contrast is mandated and no alternative pathway is acceptable).\n* Inability to lie still for the required acquisition time and sedation not feasible per institutional policy.\n* Concurrent participation in an interventional study or receipt of anticancer therapy that would confound imaging interpretation within the imaging window; for multi-tracer comparisons, any interval systemic therapy between scans.","6 Months",{"count":256,"type":19},"The goal of this clinical trial is to evaluate the diagnostic efficacy of somatostatin receptor and norepinephrine transporter targeted imaging (including 18F-MFBG, 123I-MIBG, 131I-MIBG, 68Ga-DOTA-NOC, 68Ga-DOTA-TATE, 68Ga-DOTA-TOC, and other radiolabeled somatostatin analogues) in the diagnosis and staging of neuroblastoma and pheochromocytoma\u002Fparaganglioma patients aged 1-70 years. The main questions it aims to answer are:\n\nCan molecular targeted imaging using various norepinephrine transporter tracers (18F-MFBG, 123I\u002F131I-MIBG) and somatostatin receptor tracers (68Ga-DOTA-peptides series) accurately detect primary tumors and metastatic lesions in neuroblastoma\u002Fpheochromocytoma patients? What is the comparative diagnostic performance (sensitivity, specificity, accuracy) of different molecular imaging techniques compared to histopathological diagnosis as the gold standard? Researchers will compare the imaging findings from multiple tracer types with surgical pathology results to assess diagnostic accuracy and clinical staging precision.\n\nParticipants will:\n\n* Undergo screening assessments including medical history, physical examination, and laboratory tests\n* Receive intravenous injection of selected tracers (18F-MFBG, 68Ga-DOTA-NOC\u002FTATE, or other appropriate agents) at standardized doses followed by PET-CT\u002FMRI imaging at optimal time points\n* Undergo histopathological examination within 2 months post-imaging\n* Complete safety follow-up for 6 months to monitor for any adverse reactions to the imaging agents",[389,25,26],"Neuroblastoma",[391,392,310,311,393,394],"neuroblastoma","PET","somatostatin receptor","norepinephrine transporter","2025-09-19",{"date":397,"type":35},"2025-09-26",{"date":399,"type":35},"2024-12-25",{"date":401,"type":19},"2028-06-30",{"name":403,"class":42},"Nanjing First Hospital, Nanjing Medical University",{"id":405,"slug":406,"hasResults":11,"nctId":407,"briefTitle":408,"officialTitle":409,"acronym":4,"eligibilityCriteria":410,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":411,"targetDuration":4,"studyType":20,"phases":413,"briefSummary":415,"conditions":416,"keywords":425,"overallStatus":103,"whyStopped":4,"lastUpdateSubmitDate":429,"lastUpdatePostDateStruct":430,"startDateStruct":432,"completionDateStruct":434,"leadSponsor":436,"locationsCount":43},"100545064","using-the-ehr-to-advance-genomic-medicine-across-a-diverse-health-system-100545064","NCT06377033","Using the EHR to Advance Genomic Medicine Across a Diverse Health System","Using Behavioral Economics and Implementation Science to Advance the Use of Genomic Medicine Utilizing an EHR Infrastructure Across a Diverse Health System","Inclusion Criteria:\n\n* 18 years of age or older\n* diagnosed with one of the study conditions\n\nExclusion Criteria:\n\n* Under 18 years of age\n* not diagnosed with one of the study conditions",{"count":412,"type":19},1000,[414],"NA","Given the expansion of indications for genetic testing and our understanding of conditions for which the results change medical management, it is imperative to consider novel ways to deliver care beyond the traditional genetic counseling visit, which are both amenable to large-scale implementation and sustainable. The investigators propose an entirely new approach for the implementation of genomic medicine, supported by the leadership of Penn Medicine, investigating the use of non-geneticist clinician and patient nudges in the delivery of genomic medicine through a pragmatic randomized clinical trial, addressing NHGRI priorities. Our application is highly conceptually and technically innovative, building upon expertise and infrastructure already in place.\n\nInnovative qualities of our proposal include: 1) Cutting edge EHR infrastructure already built to support genomic medicine (e.g., partnering with multiple commercial genetic testing laboratories for direct test ordering and results reporting in the EHR); 2) Automated EHR-based direct ordering or referring by specialist clinicians (i.e., use of replicable modules that enable specialist clinicians to order genetic testing through Epic Smartsets, including all needed components, such as populated gene lists, smartphrases, genetic testing, informational websites and acknowledgement e-forms for patient signature); 3) EHR algorithms for accurate patient identification (i.e., electronic phenotype algorithms to identify eligible patients, none of which currently have phenotype algorithms present in PheKB; 4) Behavioral economics-informed implementation science methods: This trial will be the first to evaluate implementation strategies informed by behavioral economics, directed at clinicians and\u002For patients, for increasing the use of genetic testing; further it will be the first study in this area to test two forms of defaults as a potential local adaptation to facilitate implementation (ordering vs. referring); and 5) Dissemination: In addition to standard dissemination modalities,PheKB95, GitHub and Epic Community Library, the investigators propose to disseminate via AnVIL (NHGRI's Genomic Data Science Analysis, Visualization, and Informatics Lab-Space). Our results will represent an entirely new paradigm for the provision of genomic medicine for patients in whom the results of genetic testing change medical management.",[417,26,25,418,419,420,421,422,423,424],"Genetic Predisposition","ALS","Parkinson Disease","Polyneuropathies","Frontotemporal Dementia","Alzheimer Disease","Cardiomyopathy Non-ischemic","Thoracic Aortic Aneurysm",[426,427,428],"Genetic testing","Genomic medicine","Electronic health record","2025-07-16",{"date":431,"type":35},"2025-07-20",{"date":433,"type":35},"2024-06-10",{"date":435,"type":19},"2027-06-30",{"name":41,"class":42},{"id":438,"slug":439,"hasResults":11,"nctId":440,"briefTitle":441,"officialTitle":442,"acronym":4,"eligibilityCriteria":443,"healthyVolunteers":11,"sex":15,"minAge":444,"maxAge":445,"enrollmentInfo":446,"targetDuration":4,"studyType":20,"phases":448,"briefSummary":449,"conditions":450,"keywords":4,"overallStatus":103,"whyStopped":4,"lastUpdateSubmitDate":453,"lastUpdatePostDateStruct":454,"startDateStruct":456,"completionDateStruct":458,"leadSponsor":460,"locationsCount":43},"100493268","phase-4-the-effect-and-safety-of-omitting-preoperative-alpha-adrenergic-blockade-for-normotensive-pheochromocytoma-100493268","NCT05702944","The Effect and Safety of Omitting Preoperative Alpha-adrenergic Blockade for Normotensive Pheochromocytoma","A Pilot Study for Randomized Controlled Trial on the Effect and Safety of Omitting Preoperative Alpha-adrenergic Blockade for Normotensive Pheochromocytoma","Inclusion Criteria:\n\n* Patients aged 19 to 70 years old\n* Patients who consented to the study and obtained consent for the study\n* Patients undergoing unilateral total adrenalectomy due to normotensive pheochromocytoma\u002Fparaganglioma with less than five times of upper limits of serum metanephrine\n\nExclusion Criteria:\n\n* Patients under 18 or over 70 years old\n* Pregnant women\n* Patients with bilateral pheochromocytoma\n* Patients suspected of malignant pheochromocytoma\u002Fparaganglioma or distant metastasis\n* Patients requiring preoperative intensive care unit due to severe hemodynamic instability\n* Patients with hypertension (the blood pressure measured more than two times is constantly greater than 140\u002F90 mmHg) or already taking a antihypertensive medication\n* Patients with a history of coronary artery disease\n* Patients with a history of arrhythmia (atrial fibrillation, Paroxysmal supraventricular tachycardia)\n* Patients with a history of cerebrovascular disease (cerebral aneurysm, cerebral infarction, cerebral hemorrhage)\n* Patients judged unsuitable by the person in charge of the clinical trial","19 Years","70 Years",{"count":447,"type":19},24,[331],"Pheochromocytoma and paraganglioma (PPGL) are rare neuroendocrine tumors originating from catecholamine producing chromaffin cells in the adrenal medulla and extra-adrenal paraganglia. The overall age-standardized incidence rate is 0.18 per 100,000 person-years in Korea.\n\nThe definitive treatment of PPGL is surgical excision of tumor. However, surgery is associated with a high risk of perioperative hemodynamic instability (HI). To avoid perioperative HI in patients diagnosed with PPGL, preoperative management including routine use of alpha blockade and volume expansion has been advocated by several guidelines.\n\nWhile unstable hypertension and tachycardia should be controlled in patients with PPGL, there is controversial that all patients diagnosed with PPGL should undergo preoperative pharmacological treatment, especially alpha blockade. The most important risk of preoperative alpha blockade use is perioperative hypotension.\n\nA recent study reported that patients diagnosed with PPGL postoperatively may have no further higher risk of intraoperative hypertension than those diagnosed preoperatively despite insufficient preoperatively management of PPGL.\n\nTherefore, it is a very important to study the relationship between HI and preoperative alpha blockade in normotensive patients diagnosed with PPGL. The aim this study is to analyze the effect and safety of omitting preoperative alpha-adrenergic blockade for normotensive pheochromocytoma through a prospective randomized controlled trial. The patients is divided into two groups. The patients in control group take a phenoxybenzamine at least 2 to 5 weeks before surgery. The patients in case group do not take a phenoxybenzamine.\n\nPrimary outcome is to evaluate the percentage of time during surgery with systolic blood pressure more than 160mmHg or average blood pressure less than 60mmHg. And secondary outcomes are to evaluate hemodynamic instability in preoperative ward and postoperative ward.",[25,26,451,452],"Adrenalectomy; Status","Adrenergics Causing Adverse Effects in Therapeutic Use","2025-06-09",{"date":455,"type":35},"2025-06-12",{"date":457,"type":35},"2023-01-18",{"date":459,"type":19},"2027-12-31",{"name":461,"class":42},"Seoul National University Hospital",{"id":463,"slug":464,"hasResults":11,"nctId":465,"briefTitle":466,"officialTitle":467,"acronym":468,"eligibilityCriteria":469,"healthyVolunteers":352,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":470,"targetDuration":4,"studyType":192,"phases":4,"briefSummary":471,"conditions":472,"keywords":473,"overallStatus":103,"whyStopped":4,"lastUpdateSubmitDate":476,"lastUpdatePostDateStruct":477,"startDateStruct":479,"completionDateStruct":481,"leadSponsor":483,"locationsCount":43},"100550248","hereditary-pheochromocytoma-assessment-of-tumour-immunologies-100550248","NCT06444607","Hereditary Pheochromocytoma Assessment of Tumour Immunologies","HEPHESTOS - Hereditary Pheochromocytoma Assessment of Tumour Immunologies","HEPHESTOS","Inclusion Criteria:\n\nPart I:\n\n* Newly diagnosed patients with PPGL or newly diagnosed patients with (metastatic) PPGL recurrence.\n* OR patients with mutations which predispose for the development of PPGL.\n* Aged \\> 18 years.\n\nPart II:\n\n* Confirmed PPGL on pathology.\n* Aged \\> 18 years.\n\nExclusion Criteria:\n\n* Unable to provide informed consent.\n* Active inflammatory or infectious comorbidities.\n* Other malignancies which are under active treatment (except for basal cell carcinoma, other in situ carcinomas).\n* Using medication interfering with the immune system\n* Pregnancy or breastfeeding\n* A self-reported alcohol consumption of \\>21 units per week",{"count":190,"type":19},"In this study, the investigators are examining the role of the immune system in pheochromocytoma and paraganglioma. The investigators aim to examine the differences in the immune system between people who have these tumors with and without a hereditary predisposition. The investigators also want to see how the immune system changes during the development of the tumor in people with a hereditary predisposition. Finally, the investigators will compare the data with a control group of people without these tumors. Ultimately, the investigators hope that the results will contribute to the discovery of new immune system-targeted medications for pheochromocytoma and paraganglioma.",[25,26],[25,26,474,475],"Tumor microenvironment","Innate immunity","2024-11-18",{"date":478,"type":35},"2024-11-21",{"date":480,"type":35},"2024-06-01",{"date":482,"type":19},"2029-06-01",{"name":484,"class":42},"Radboud University Medical Center",{"id":486,"slug":487,"hasResults":11,"nctId":488,"briefTitle":489,"officialTitle":490,"acronym":491,"eligibilityCriteria":492,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":493,"targetDuration":4,"studyType":20,"phases":495,"briefSummary":496,"conditions":497,"keywords":4,"overallStatus":103,"whyStopped":4,"lastUpdateSubmitDate":498,"lastUpdatePostDateStruct":499,"startDateStruct":501,"completionDateStruct":503,"leadSponsor":505,"locationsCount":507},"100519569","phase-2-receptor-radionuclide-therapy-with-177lu-dotatoc-100519569","NCT06045260","\"Receptor Radionuclide Therapy With 177Lu-DOTATOC","\"Receptor Radionuclide Therapy With 177Lu-DOTATOC (177Lu-edotreotide or 177Lu-octreotide) in SSTR Positive Patients: a Multicenter, Prospective, Phase II Trial\"","LUFOR","Inclusion Criteria:\n\n1. Age ≥18 years.\n2. Patients must have histologically or cytologically confirmation of neuroendocrine tumors or any other tumor histology type documented as sst2-positive, that may benefit from receptor radionuclide therapy and for which there are not any other effective treatments, included locoregional methods of control for PPGLs\u002Fpheochromocytoma. For cerebral and PPGLs sst2- positive tumors, if biopsy is no feasible for technical reason or risk benefit balance, patients may be enrolled if CT or MRI strongly suggest oncological lesion confirming the 68Ga PET-CT dota-peptide SSTr2 positivity.\n3. Measurable disease according to RECIST 1.1 criteria also patients without measurable but with evaluable disease can be enrolled.\n4. Any disease stage is allowed. Patients with documented disease will be admitted to the therapeutic phase only if the diagnostic PET\u002FCT 68Ga-peptide images demonstrate a significant uptake in the tumour, according to the adapted Krenning Scale. Only patients with a greater caption (Grade 3 or 4) in most of the lesions will be admitted.\n5. Patients with progressive disease in pre-study period (PD within the last 12 months), refractory to conventional standard treatments; clinical progression is allowed.\n6. Patients with or without concurrent therapy with somatostatin analogs. It will be maintained the same dose of the SSA analogs as at the time of demonstrated disease progression.\n7. Life expectancy of greater than 6 months.\n8. ECOG performance status \\\u003C2.\n9. Adequate haematological, liver and renal function: haemoglobin \\>= 9 g\u002FdL, absolute neutrophil count (ANC) \\>= 1.5 x 109 \u002FL, platelets \\>= 100 x 109 \u002FL, bilirubin ≤1.5 X UNL (upper normal limit), ALT and AST \\\u003C2.5 X UNL (\\\u003C 5 X UNL in presence of liver metastases), creatinine \\\u003C 2 mg\u002FdL and\u002For eGFR or creatinine clearance \\> 50 ml\u002Fmin.\n10. If female of childbearing potential highly effective birth control methods, according to guideline \"Recommendation related to contraception and pregnancy testing in clinical trials\", (2014\\_09\\_15 section 4.1) are mandatory (see Appendix F). Highly effective birth control methods are required beginning at the screening visit and continuing until 6 months following last treatment with study drug. A negative serum pregnancy test should be performed the same day the treatment is started at any cycle. Male patient and his female partner who is of childbearing potential must use 2 acceptable methods of birth control (1 of which must include a condom as a barrier method of contraception) starting at screening and continuing throughout the study period and for 6 months after final study drug administration. Two acceptable methods of birth control thus include Condom (barrier method of contraception) and one of the following is required (established use of oral, or injected or implanted hormonal method of contraception by the female partner; placement of an intrauterine device (IUD) or intrauterine system (IUS) by the female partner; additional barrier method like occlusive cap with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository in the female partner; tubal ligation in the female partner; vasectomy or other procedure resulting in infertility (eg, bilateral orchiectomy), for more than 6 months (see Appendix F).\n11. Participant is willing and able to give informed consent for participation in the study.\n\nExclusion Criteria:\n\n1. Patients treated with chemotherapy and therapeutic radiotherapy within 4 weeks and treated within 2 weeks with palliative radiotherapy, hormonal or biological therapy.\n2. Known hypersensitivity to lutetium-177 (177Lu), edotreotide, DOTA or components of the formulation or other radiolabeled peptide agents.\n3. Known hypersensitivity to lysine, arginine, or any excipient of the nephroprotective aminoacids given concurrently with the lutetium (177Lu) edotreotide infusion;\n4. Patients treated with prior external beam radiation therapy (EBRT) to more than 25% of the bone marrow.\n5. Patients treated with previous PRRT with an absorbed dose to the kidney more than 23 Gy and more than 1.8 Gy for the bone marrow or as surrogate of dosimetry (13).\n6. Patients which are included in the indication of LUTATHERA®(9).\n7. All acute toxic effects of any prior therapy (including surgery, radiation therapy, chemotherapy) must have resolved to a grade ≤ 1 according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE).\n8. ECOG performance status \\>2.\n9. Participation in another clinical trial with any investigational agents within 30 days prior to study screening.\n10. 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 that would limit compliance with study requirements.\n11. Pregnant or breastfeeding women are excluded from the present study.",{"count":494,"type":19},100,[56],"Peptide receptor radionuclide therapy (PRRT) may be recommended in G1- G2 GEP-NET patients with disease progression on somatostatine analogues therapy (LUTATHERA®). However, there are several diseases, including neuroendocrine neoplasia not originating from the digestive tract, for which the efficacy of PRRT has already been demonstrated, but which are not currently within the indications of LUTATHERA and therefore cannot benefit from it (i.e. bronchopulmonary, ovarian, renal NETs and neuroendocrine carcinomas). Moreover, the role of PRRT is also accepted in Pheochromocytomas and paragangliomas (PPGLs), Meningiomas, but also as a salvage therapy in pre-treated NET pts, and other SSTR-positive malignancies (Lymphomas, Gliomas…). Least explored among radiopharmaceuticals for SSTR-positive tumors is 177Lu-DOTATOC. This study aims to investigate the efficacy and safety of lutetium (177Lu) edotreotide (Lu-Dotatoc) on all the above-mentioned diseases that could benefit from receptor radionuclide therapy. We believe that this study, which will involve only patients outside the indication of LUTATHERA, will expand the current knowledge of radionuclide receptor therapy with 177Lu- DOTATOC, particularly with regard to objective response and safety parameters, and may consolidate its in the management of these diseases.",[27,26,25],"2024-08-09",{"date":500,"type":35},"2024-08-13",{"date":502,"type":35},"2023-09-13",{"date":504,"type":19},"2027-01",{"name":506,"class":42},"Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS",2,{"id":509,"slug":510,"hasResults":11,"nctId":511,"briefTitle":512,"officialTitle":512,"acronym":4,"eligibilityCriteria":513,"healthyVolunteers":352,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":514,"targetDuration":4,"studyType":192,"phases":4,"briefSummary":516,"conditions":517,"keywords":4,"overallStatus":103,"whyStopped":4,"lastUpdateSubmitDate":540,"lastUpdatePostDateStruct":541,"startDateStruct":543,"completionDateStruct":545,"leadSponsor":547,"locationsCount":247},"100556321","genetic-bases-of-neuroendocrine-neoplasms-in-mexican-patients-100556321","NCT06523582","Genetic Bases of Neuroendocrine Neoplasms in Mexican Patients","Inclusion Criteria:\n\nAdult patients with a new or previous clinical diagnosis of any of the following conditions:\n\n* Isolated NENs with sporadic presentation, including bronchopulmonary NENs, gastrointestinal NENs, medullary thyroid carcinoma, pancreatic NENs, paragangliomas, pheochromocytomas, pituitary neuroendocrine tumors, and primary hyperparathyroidism.\n* Familial isolated NENs, including familial isolated pituitary adenoma, familial pheochromocytomas and paragangliomas, familial primary hyperparathyroidism, familial gastrointestinal stromal tumors and X-linked acrogigantism.\n* Clinical syndromes encompassing NENs, with familial or sporadic presentation, including Carney complex, Carney-Stratakis syndrome, Carney triad, Cowden syndrome, DICER1 syndrome, Li-Fraumeni syndrome, Lynch syndrome, multiple endocrine neoplasia type 1, multiple endocrine neoplasia type 2, multiple endocrine neoplasia type 4, neurofibromatosis type 1, Pacak-Zhuang syndrome, paraganglioma, pheochromocytoma and pituitary adenoma syndrome, tuberous sclerosis complex, Von Hippel Lindau syndrome.\n\nExclusion criteria:\n\n* Age \\\u003C18 years.\n* Refusal to give informed consent.",{"count":515,"type":19},750,"Neuroendocrine neoplasms (NENs) are a heterogeneous group of lesions derived from cells with the ability to produce hormones that may arise from multiple different organs. Their clinical behavior is quite variable, encompassing both benign lesions and aggressive tumors that invade surrounding and\u002For distant structures. NENs may also cause serious morbidity due to hormone oversecretion. NENs are among the most frequently inherited human tumors, presenting either isolated or as part of syndromes in which a single patient or family develops multiple tumors. There are also non-inherited changes in the genetic information of the tumor cells that are potential targets for treatment. Both inherited and non-inherited DNA defects can be identified using modern routine genetic tests which, unfortunately, are not widely available in Mexico.\n\nThis project seeks to uncover the genetic defects causing NENs in a large cohort of Mexican patients, using three different methods for genetic testing. Adult individuals with various types of NENs from two reference hospitals in Mexico City will be invited to participate. After completing informed consent, blood and, if possible, tissue samples will be obtained from all participants. Clinical details, laboratory results, imaging studies, and histopathological data at disease presentation will be retrieved.\n\nAn initial screening will be performed by analyzing changes in the sequence of multiple genes that have been associated with the occurrence of NENs. In cases with negative screening, a specific method to assess changes in the number of copies of the same genes will also be employed. Finally, sequences of all DNA regions encoding information required to make proteins will be obtained in selected cases. Analyses will be carried out in blood and, if available, also in tumor tissue samples from study participants. Screening of additional family members will be offered.\n\nThis project will accurately describe the repertoire of specific defects causing NENs in the study population, and will likely uncover and characterize novel genetic associations. The results will contribute for a better understanding of the alterations within and outside known driver genes that shape syndromic presentations, tumor behaviors, and inheritance patterns in individuals with NENs. These data will contribute to improve the information on the molecular bases of NENs, including alterations that can be used as therapeutic targets.",[518,519,520,521,522,523,28,26,25,524,525,526,527,528,529,530,531,532,533,534,535,286,536,537,538,539],"Neuroendocrine Neoplasm","Neuroendocrine Neoplasm of Gastrointestinal Tract","Neuroendocrine Neoplasm of Lung","Thymic Neuroendocrine Neoplasm","Neuroendocrine Tumor of Pancreas","Gastrointestinal Stromal Tumors","Primary Hyperparathyroidism","Pituitary Tumor","Multiple Endocrine Neoplasia Type 1","Multiple Endocrine Neoplasia Type 2","Multiple Endocrine Neoplasia Type 4","Carney Complex","Carney Stratakis Dyad","Carney Triad","Cowden Syndrome","DICER1 Syndrome","Li-Fraumeni Syndrome","Lynch Syndrome","Familial Isolated Pituitary Adenoma","X-Linked Acrogigantism","Neurofibromatosis 1","Tuberous Sclerosis","2024-07-22",{"date":542,"type":35},"2024-07-26",{"date":544,"type":35},"2022-08-03",{"date":546,"type":19},"2037-03-01",{"name":548,"class":42},"Universidad Nacional Autonoma de Mexico",{"id":550,"slug":551,"hasResults":11,"nctId":552,"briefTitle":553,"officialTitle":554,"acronym":4,"eligibilityCriteria":555,"healthyVolunteers":11,"sex":15,"minAge":556,"maxAge":557,"enrollmentInfo":558,"targetDuration":4,"studyType":20,"phases":560,"briefSummary":561,"conditions":562,"keywords":4,"overallStatus":103,"whyStopped":4,"lastUpdateSubmitDate":564,"lastUpdatePostDateStruct":565,"startDateStruct":567,"completionDateStruct":569,"leadSponsor":571,"locationsCount":43},"100444575","early-phase-1-18f-mfbg-petct-in-the-evaluation-of-neural-crest-tumor-100444575","NCT05069220","18F-MFBG PET\u002FCT in the Evaluation of Neural Crest Tumor","A Study of 18F-MFBG Imaging for the Tumor Burden Evaluation or Diagnostic Performance in Pheochromocytoma, Paraganglioma and Neuroblastoma.","Inclusion Criteria:\n\n\\- The subject has read, signed, and dated an informed consent form (ICF) prior to any study procedures being performed. Patients with histologically confirmed or clinically suspicious neural crest tumor.\n\nFor patients with neuroblastoma, subject should have a routine clinical 123I-MIBG scintigraphy (planar + SPECT\u002FCT) performed within 6 months prior to the inclusion visit or scheduled within 3 months after the inclusion visit.\n\nThe subject is male or is a nonpregnant, nonlactating female who is either surgically sterile or is post-menopausal. The subject is able and willing to comply with all study procedures as described in the protocol.\n\nExclusion Criteria:\n\n\\- Patients are potentially pregnant (serum and urinary hCG test will be performed in women where pregnancy is not excluded) or is breast-feeding.\n\nPatients undergo surgery between the selection and inclusion visit. Patients who are pregnant, may possibly be pregnant, or wish (including their partners) to become pregnant during the study period, or are lactating. Patients who are not suitable to participate in the trial according to researchers.","1 Year","80 Years",{"count":559,"type":19},150,[258],"The aim of this study is to evaluate the diagnostic performance and tumor burden of 18F-metafluorobenzylguanidine (18F-MFBG) positron emission tomography (PET) in patients with neuroendocrine tumors mainly in pheochromocytoma and paraganglioma (PPGL) and neuroblastoma (NB).",[563,389,25,26],"Neuroendocrine Tumor","2024-02-28",{"date":566,"type":35},"2024-03-01",{"date":568,"type":35},"2021-09-01",{"date":570,"type":19},"2026-12",{"name":210,"class":42},{"id":573,"slug":574,"hasResults":11,"nctId":575,"briefTitle":576,"officialTitle":577,"acronym":578,"eligibilityCriteria":579,"healthyVolunteers":11,"sex":15,"minAge":580,"maxAge":581,"enrollmentInfo":582,"targetDuration":4,"studyType":192,"phases":4,"briefSummary":584,"conditions":585,"keywords":590,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":594,"lastUpdatePostDateStruct":595,"startDateStruct":597,"completionDateStruct":599,"leadSponsor":601,"locationsCount":507},"100423060","development-of-a-predictive-model-for-the-risk-of-metastatic-disease-in-ppgls-a-retrospective-cohort-study-100423060","NCT04788927","Development of a Predictive Model for the Risk of Metastatic Disease in PPGLs, a Retrospective Cohort Study","Development of a Comprehensive Predictive Model for Risk of Metastatic Disease in PPGLs Based on a Combination of Clinical, Biochemical, Genetic, and Pathoanatomical Characteristics a Retrospective National Cohort Study","PPGL-Pred","Inclusion Criteria:\n\n* All Danish patients diagnosed with PPGLs or genetic variants that predispose to PPGLs since 1996 will be included.\n\nExclusion Criteria:\n\n* None from the initial data collection. If there are no tumour tissue or blood samples from a patient in the biobanks they will subsequently be excluded.","0 Years","120 Years",{"count":583,"type":19},400,"Phaeochromocytomas and paragangliomas (PPGLs) are tumours of the adrenal medulla and extra-adrenal sympathetic nervous system, some which can become metastatic. It is a very rare disease and the tumours are often detected late. Approximately 50 % of the tumours are caused by germline genetic variants screening programmes are recommended for patients and their family members; however, they are not yet well-targeted with respect to individual prognosis. In this study the investigatorscaim to characterize the genotype-phenotype associations in all Danish patients (n=400) diagnosed with PPGLs who have been followed in tertiary centres using medical records and national registries. To this end novel immunohistochemical, genetic, and epigenetic biomarkers in tumour tissues samples from biobank material (blood samples and tumour tissue) will be investigated to develop a comprehensive predictive algorithm for disease prognosis. The study will provide a clinical tool for an improved targeted screening program and subsequently prevention of disease development.",[26,25,586,587,588,589,27],"Genetic Predisposition to Disease","Pathology","Somatic Mutation","Head and Neck Cancer",[26,591,592,587,593],"Phaeochromocytoma","Clinical genetics","Translational research","2023-04-06",{"date":596,"type":35},"2023-04-07",{"date":598,"type":19},"2023-10-01",{"date":600,"type":19},"2027-09-30",{"name":602,"class":42},"Rigshospitalet, Denmark",{"id":604,"slug":605,"hasResults":11,"nctId":606,"briefTitle":607,"officialTitle":608,"acronym":4,"eligibilityCriteria":609,"healthyVolunteers":11,"sex":15,"minAge":610,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":611,"phases":4,"briefSummary":612,"conditions":613,"keywords":4,"overallStatus":614,"whyStopped":4,"lastUpdateSubmitDate":615,"lastUpdatePostDateStruct":616,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":618,"locationsCount":151},"100177939","expanded-access-protocol-using-131i-mibg-100177939","NCT01590680","Expanded Access Protocol Using 131I-MIBG","An Open Label, Expanded Access Protocol Using 131I-metaiodobenzylguanidine (131I-MIBG) Therapy in Patients With Refractory Neuroblastoma, Pheochromocytoma, or Paraganglioma (Not Eligible for Approved Treatment)","INCLUSION CRITERIA:\n\n1. Diagnosis: Refractory or relapsed neuroblastoma with original diagnosis based on tumor histopathology or elevated urine catecholamines with typical tumor cells in the bone marrow, OR pheochromocytoma or paraganglioma (less than 12 years of age) not amenable to curative surgery.\n2. Age ≥12 months and able to cooperate with radiation safety restrictions during therapy period with\u002Fwithout pharmacologic anxiolysis.\n3. Disease status: Failure to respond to standard therapy (usually combination chemotherapy with or without radiation and surgery) or development of progressive disease at any time (any new lesion or an increase in size of \\>25% of a pre-existing lesion). Disease evaluation must be completed within 8 weeks of study entry. If possible, the disease evaluation should take place subsequent to any intervening therapy; if intervening therapy does occur, evaluations should be done as clinically indicated. If patient has received prior treatment with MIBG, they must have a response or stable disease after the most recent MIBG infusion. Patient may have PD after showing an initial response to MIBG therapy (at \\[or around\\] the day 35-63 post-MIBG therapy evaluation).\n4. Stem cells: Patients must have a hematopoietic stem cell product available for re-infusion after 131I-MIBG treatment at doses of 12 mCi\u002Fkg. If no stem cells are available, then the dose of 131I-MIBG should be \\\u003C12 mCi\u002Fkg.\n5. Prior Therapy: Patients may enter this study with or without re-induction therapy for recurrent tumor. Patients must have fully recovered from the toxic effects of any prior therapy, meeting the following criteria:\n\n   1. At least 2 weeks should have elapsed since any anti-tumor therapy and the patient must meet certain hematologic criteria.\n   2. 3 months should have elapsed in the case of completing external beam radiation for total abdominal, whole lung, total body irradiation (spot irradiation to skull-based metastases is NOT a contraindication). Patients who receive localized emergency radiation to sites of life-threatening or function-threatening disease prior to or immediately after establishment of the definitive diagnosis are not contraindicated for treatment on this protocol.\n   3. Cytokine therapy (e.g. G-CSF, GM-CSF, IL-6, erythropoietin) must be discontinued a minimum of 24 hours prior to 131I-MIBG therapy.\n   4. Minimum of six weeks from previous 131I-MIBG therapy.\n   5. The lifetime cumulative injected activity should be evaluated by the Investigator on a case-by-case basis with special attention to any recovery from past 131I-MIBG dose(s).\n   6. For patients who received a stem cell infusion for a previous 131I-MIBG therapy but do NOT have remaining stored stem cells:\n\n   i. If the stem cell reinfusion was protocol driven but not based upon the development of profound cytopenias (e.g. automatic stem cell reinfusion on Day 14), the patient is eligible for retreatment with MIBG at a dose \\\u003C12 mCi\u002Fkg at the investigators discretion; ii. If the stem cell reinfusion was given based upon the development of profound cytopenias, decisions for re-treatment with 131I-MIBG will require a case-by-case evaluation by the Investigator.\n6. Organ Function:\n\n   1. Liver function: Bilirubin ≤ 2x upper limit of normal; AST\u002FALT ≤ 10x upper limit of normal.\n   2. Kidney function:\n\n   i. Serum Creatinine ≤ 2x upper limit of normal OR ii. 24-hr creatinine clearance OR GFR ≥ 60 ml\u002Fmin\u002F1.73m2.\n\n   c. Hematologic Criteria: ANC ≥750\u002FuL; Platelets ≥ 50,000\u002FuL without transfusion if stem cells are not available (ANC ≥ 500 and any platelet count allowed if stem cells available). Patient must be off myeloid growth factors for at least 24 hours. If the patient has received prior treatment with MIBG, they may be thrombocytopenic, but requiring no more than 2 platelet transfusions per week to maintain counts above 20,000\u002FuL. Hemoglobin must be ≥ 10gm\u002FdL (transfusion allowed) regardless of stored stem cell availability.\n\n   d. Normal lung function, as manifested by no dyspnea at rest or exercise intolerance, no oxygen requirement.\n\n   e. No clinically significant cardiac dysfunction.\n7. Signed informed consent\u002Fassent has been obtained.\n\nEXCLUSION CRITERIA:\n\n1. Patients 12 years and older with iobenguane scan positive, unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma and marketed product is available.\n2. Patients eligible for the Phase II (OPTIMUM) trial.\n3. Patients with disease of any major organ system that would compromise their ability to withstand therapy. Any significant organ impairment should be discussed with the Principal Investigator prior to patient entry.\n4. Because of the teratogenic potential of the study medications, no patients who are pregnant or lactating will be allowed. Patients of childbearing potential, who are sexually active, must practice an effective method of birth control while participating on this study, to avoid possible damage to the fetus . \\[e.g. intrauterine device, double-barrier method (i.e., diaphragm, or a cervical cap) with intravaginal spermicidal foam, cream or gel\\], or male partner sterilization throughout the study\\].\n5. Patients who are on hemodialysis\n6. Proteinuria, in the absence of urinary infection, within 4 weeks prior to the planned treatment date is a relative contraindication to receiving therapy for patients with pheochromocytoma\u002Fparaganglioma. Patients with pheochromocytoma\u002Fparaganglioma with any clinically significant proteinuria must have a 24-hr urine protein determination. If proteinuria is confirmed as being above the institutional upper limit of normal, the patient is ineligible for MIBG therapy.\n7. Patients with active infections that meet grade 3-4 according to the current version of the NCI CTCAE.\n8. Patients with known MIBG-avid parenchymal brain metastases are not eligible. (Patients with leptomeningeal or skull-based metastases are eligible.)","12 Months","EXPANDED_ACCESS","Protocol JDI2007-01 is an Expanded Access Protocol with therapeutic 131I-MIBG for patients with neuroblastoma or pheochromocytoma \u002F paraganglioma, who otherwise do not qualify for available treatments, or where approved treatment is not commercially available.",[389,25,26],"AVAILABLE","2023-02-26",{"date":617,"type":35},"2023-02-28",{"name":619,"class":150},"Jubilant DraxImage Inc.",{"id":621,"slug":622,"hasResults":11,"nctId":623,"briefTitle":624,"officialTitle":625,"acronym":626,"eligibilityCriteria":627,"healthyVolunteers":11,"sex":15,"minAge":628,"maxAge":4,"enrollmentInfo":629,"targetDuration":4,"studyType":20,"phases":631,"briefSummary":632,"conditions":633,"keywords":4,"overallStatus":103,"whyStopped":4,"lastUpdateSubmitDate":634,"lastUpdatePostDateStruct":635,"startDateStruct":637,"completionDateStruct":639,"leadSponsor":641,"locationsCount":43},"100312174","multicenter-pheochromocytoma-and-paraganglioma-evaluation-100312174","NCT03344016","Multicenter Pheochromocytoma and Paraganglioma Evaluation","The MUPPET-study: Multicenter Pheochromocytoma and Paraganglioma Evaluation for Follow-up Screening, Genetics Sub-Typing, Therapy and Outcome","MUPPET","Inclusion Criteria:\n\nmale and female patients (≥ 5 years of age), who fulfill one or more of the following criteria: (i) Patients with a newly diagnosed PPGL. (ii) Patients with a previous history of PPGLs. (iii) Carrier of genetic mutations known to predispose for the development of PPGLs.\n\nAll subjects must have read, understood and signed the informed consent form, before inclusion into the study protocol. Signed parental consent must be obtained for children with suspected PPGLs who are enrolled in the study.\n\nExclusion Criteria:\n\n* Patients with impaired mental capacity that precludes informed consent.\n* Pregnancy does not constitute criteria for exclusion from the protocol. However, in pregnant women no Clonidine testing, no PET scanning, MIBG scanning or contrast CT will be performed.\n* Patients at risk from injury from the MRI magnet due to implantable metal or who suffer from anxiety in enclosed spaces are excluded from MRI.","5 Years",{"count":630,"type":19},1148,[414],"Target population:\n\nPatients with (1) newly diagnosed or (2) past history of pheochromocytomas and paragangliomas (PPGL) or (3) carrier of genetic mutations in known PPGL susceptibility genes.\n\nInternational multicenter prospective cohort study with randomized intervention (special care follow-up vs. standard care follow-up).\n\nAll patients will receive instructions about follow-up at the time point of study inclusion. Patients randomized to the standard care follow-up group will be advised to return annually for follow-up according to current routine practice (without active re-scheduling). In contrast, patients randomized to the special care follow-up group will also be advised to return annually for follow-up but these patients will be actively invited, re-scheduled and reminded by the centers to meet scheduled follow-up appointments.",[25,26],"2020-07-07",{"date":636,"type":35},"2020-07-09",{"date":638,"type":35},"2017-11-01",{"date":640,"type":19},"2040-11-01",{"name":642,"class":42},"Felix Beuschlein"]