[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"gastroenteropancreatic-neuroendocrine-tumor\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:gastroenteropancreatic-neuroendocrine-tumor":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,63,89,130,161,183,209,234,254,280],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":35,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":62},"100605639","phase-1-study-of-ryz401-in-subjects-with-solid-tumors-expressing-sstrs-100605639",false,"NCT07165132","Study of RYZ401 in Subjects With Solid Tumors Expressing SSTRs.","Phase 1 First-in-Human, Dose Escalation and Dose Expansion Study of RYZ401, a Novel Radiopharmaceutical Therapy Labeled With Actinium-225, in Subjects With Neuroendocrine Tumors and Other Solid Tumors Expressing Somatostatin Receptors.","Inclusion criteria:\n\n* At least 18 years old at the time of signing the main study informed consent form (ICF).\n* Histologically confirmed:\n\nDose Escalation (all cohorts): Grades 1-3 WD, metastatic or locally advanced and unresectable NET at any primary site, including, but not limited to, GI, pancreatic, lung, thyroid, breast, urogenital, and adrenal tumors.\n\n* Dose Expansion Cohort A: Grades 1-3 WD, metastatic or locally advanced and unresectable GEP-NETs\n* Dose Expansion Cohort B: metastatic or locally advanced and unresectable tumors known to frequently express SSTR, limited to the following indications:\n\n  * WD NETs (Grades 1-3) from primary sites other than gastrointestinal and pancreatic (including, but not limited to, lung, thyroid, breast, urogenital, and adrenal tumors) Meningioma (Grades 1-3)\n\n    * SSTR-positive disease, as assessed by SSTR-PET imaging\n    * Adequate renal, hematologic and hepatic function\n\nExclusion criteria:\n\n* Prior RPT, including Lu-177.\n* Prior solid organ or bone marrow transplantation.\n* Use of chronic systemic steroid therapy.\n* Significant cardiovascular disease\n* Resistant hypertension\n* Uncontrolled diabetes\n* Prior history of liver cirrhosis\n* HIV, hepatitis B infection or known active hepatitis C virus infection.\n\nNote: Additional criteria may apply and will be assessed by the study site","ALL","18 Years",{"count":19,"type":20},104,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","The primary objectives are to determine the recommended Phase 2 dose (RP2D) and optimal treatment regimen, characterize safety and tolerability, and evaluate preliminary efficacy of RYZ401 in subjects with NETs and other selected solid tumors expressing SSTRs.",[26,27,28,29,30,31,32,33,34],"GEP-NET","Gastroenteropancreatic Neuroendocrine Tumor","Gastroenteropancreatic Neuroendocrine Tumor Disease","Neuroendocrine Tumors","Carcinoid","Carcinoid Tumor","Pancreatic NET","Solid Tumor","Somatostatin Receptor",[29,36,26,37,27,38,39,40,33,41,42,43,44,45,46,47,48,49],"SSTR+","Targeted Radiotherapy","Actinium","Ac 225","PRRT","Somatostatin Receptors","Radiopharmaceutical","BMS","Bristol Myers Squibb","Rayze","SSTR","RayzeBio","Well-differentiated NET","WD NETs","RECRUITING","2026-06-08",{"date":53,"type":54},"2026-06-09","ACTUAL",{"date":56,"type":54},"2025-12-03",{"date":58,"type":20},"2033-04",{"name":60,"class":61},"RayzeBio, Inc.","INDUSTRY",9,{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":70,"enrollmentInfo":71,"targetDuration":4,"studyType":73,"phases":4,"briefSummary":74,"conditions":75,"keywords":76,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":4},"100643414","a-study-of-treatment-patterns-and-outcomes-in-gastroenteropancreatic-neuroendocrine-tumor-gep-net-patients-100643414","NCT07635316","A Study of Treatment Patterns and Outcomes in Gastroenteropancreatic Neuroendocrine Tumor (GEP-NET) Patients","Treatment Patterns and Outcomes in GEP NET: A Retrospective Observational Cohort Study (PRIME Initiative)","Inclusion criteria:\n\n1. Patients with ≥1 International Classification of Diseases Clinical Modification, 10th revision (ICD-10-CM) diagnosis code for GEP-NET between 01 January 2018 and 31 December 2025. The date of the first such claim will be defined as the diagnosis date.\n2. Initiation of first-line (1L) systemic therapy (i.e., somatostatin analogs \\[SSAs\\], targeted therapy, peptide receptor radionuclide therapy \\[PRRT\\], chemotherapy) indicated for GEP-NET on or after the date of diagnosis. The date of treatment initiation will be defined as the index date.\n3. Patients ≥18 years of age on the index date\n4. Patients with ≥12 months (360 days) of continuous data availability (proxy for continuous health plan enrollment) prior to the index date, defined as:\n\n   1. ≥1 medical and pharmacy claim \\>12 months prior to the index date; AND\n   2. ≥1 medical and pharmacy claim within the first 6 months of the 12-month period prior to the index date; AND\n   3. ≥1 medical and pharmacy claim during the last 6 months of the 12-month period prior to the index date; AND\n5. Patients with ≥1 month (30 days) of continuous data availability (proxy for continuous health plan enrollment) following the index date, defined as:\n\n   1. ≥ 1 pharmacy dispensing a GEP-NET treatment at any time during the post-index period, including the index date, reports data during the first month following the index date\n   2. ≥ 1 provider prescribing a GEP-NET treatment at any time during the post-index period, including the index date, reports data during the first month following the index date\n\nExclusion criteria:\n\n1. Patients with evidence of GEP-NET prior to the diagnosis date within the study period\n2. Patients with evidence of GEP-NET treatment prior to the index date within the study period\n3. Patients with missing or invalid age or sex\n4. Patients with other primary malignancies during the 12-month pre-index period\n5. Patients with invalid death date (i.e., death date ≤ index date)","110 Years",{"count":72,"type":20},4023,"OBSERVATIONAL","This study aims to characterize current treatment patterns and clinical outcomes among newly diagnosed GEP-NET patients in the United States using open-source Longitudinal Prescription Claims (LRx) and Patient Centric Medical Claims (Dx) databases supplemented with mortality data.",[27],[77,78,79],"Real-world evidence","Treatment patterns","Lutathera","NOT_YET_RECRUITING","2026-06-04",{"date":53,"type":54},{"date":84,"type":20},"2026-06-12",{"date":86,"type":20},"2027-02-25",{"name":88,"class":61},"Novartis Pharmaceuticals",{"id":90,"slug":91,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":4,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":96,"enrollmentInfo":97,"targetDuration":4,"studyType":21,"phases":99,"briefSummary":101,"conditions":102,"keywords":109,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":129},"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":98,"type":20},300,[23,100],"PHASE2","This study is Phase I\u002FIIa First-in-Human Study of \\[212Pb\\]VMT-α-NET Targeted Alpha-Particle Therapy for Advanced SSTR2 Positive Tumors",[103,104,27,105,106,107,108],"Neuroendocrine Tumors Unresectable","Neuroendocrine Tumor Metastatic","Bronchial Neuroendocrine Tumor","Paraganglioma","Pheochromocytoma","Meningioma",[110,111,29,112,113,114,115,116,117,118,119,108],"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":122,"type":54},"2026-05-14",{"date":124,"type":54},"2023-09-27",{"date":126,"type":20},"2029-12-26",{"name":128,"class":61},"Perspective Therapeutics",19,{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":136,"eligibilityCriteria":137,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":138,"targetDuration":4,"studyType":21,"phases":140,"briefSummary":142,"conditions":143,"keywords":144,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":160},"100475949","phase-3-study-of-ryz101-compared-with-soc-in-pts-w-inoperable-sstr-well-differentiated-gep-net-that-has-progressed-following-177lu-ssa-therapy-100475949","NCT05477576","Study of RYZ101 Compared With SOC in Pts w Inoperable SSTR+ Well-differentiated GEP-NET That Has Progressed Following 177Lu-SSA Therapy","Phase 1b\u002F3 Global, Randomized, Controlled, Open-label Trial Comparing Treatment With RYZ101 to Standard of Care Therapy in Subjects With Inoperable, Advanced, SSTR+, Well-differentiated GEP-NETs That Have Progressed Following Prior 177Lu-SSA Therapy","ACTION-1","Inclusion:\n\n* Histologically proven, Grade 1-2 well differentiated, inoperable, advanced GEP-NETs (Ki67 ≤20%) Eastern Cooperative Oncology Group (ECOG) status 0-2. Ki67% \\\u003C20% is not required for the ad hoc subcohort of the PK\u002FECG substudy.\n* Progressive, SSTR-PET positive (i.e., Krenning score 3 or 4) GEP-NET (GI or pancreas) following 2-4 cycles of treatment with 177Lu-labeled SSA. Must have achieved disease control for at least 6 months following Lu-177 SSA (archival tissue is not required for the ad hoc subcohort of the PK\u002FECG substudy). No time limit is defined between 177Lu-SSA treatment and randomization. There must be at least 1 SSTR-PET imaging-positive measurable site of disease (according to RECIST v1.1) and no RECIST v1.1 measurable metastatic lesions that are SSTR imaging-negative.\n* Adequate renal function, as evidenced by estimated glomerular filtration rate (eGFR) ≥60 mL\u002Fmin\u002F1.73 m2 (calculated using the Chronic Kidney Disease Epidemiology Collaboration \\[CKD-EPI\\]) (Levey et al. 2009)\n* Adequate hematologic function, defined by the following laboratory results:\n* Part 2: Hemoglobin concentration ≥5.0 mmol\u002FL (≥8.0 g\u002FdL); ANC ≥1000 cells\u002FµL (≥1000 cells\u002Fmm3); platelets ≥75 x 109\u002FL (75 x 103\u002Fmm3).\n* Total bilirubin ≤3 x upper limit normal (ULN)\n* Serum albumin ≥3.0 g\u002FdL unless prothrombin time is within the normal range\n\nExclusion:\n\n* Prior radioembolization\n* Significant cardiovascular disease, such as New York Heart Association (NYHA) Class ≥II heart failure, left ventricular ejection fraction (LVEF) \\\u003C40% or QT interval corrected for heart rate using Fridericia's formula (QTcF) \\>450 ms for males and \\>470 ms for females.\n* Resistant hypertension, defined as uncontrolled blood pressure (BP) \\>140\u002F90 mmHg while on optimal doses of at least 3 antihypertensive medications with 1 being a diuretic (Whelton et al. 2018)\n* Uncontrolled diabetes mellitus as defined by hemoglobin A1C (HgB A1C) ≥8%\n* PRRT other than Lu-177 SSA (not applicable for ad hoc subcohort of the PK\u002FECG substudy)\n* Any condition requiring systemic treatment with high-dose glucocorticoids within 14 days prior to first dose of study treatment and\u002For which cannot be stopped while on study. Inhaled or topical steroids are permitted.\n* Prior history of liver cirrhosis or liver transplantation",{"count":139,"type":20},338,[141],"PHASE3","This study aims to determine the safety, pharmacokinetics (PK) and recommended Phase 3 dose (RP3D) of RYZ101 in Part 1, and the safety, efficacy, and PK of RYZ101 compared with investigator-selected standard of care (SoC) therapy in Part 2 in subjects with inoperable, advanced, well-differentiated, somatostatin receptor expressing (SSTR+) gastroenteropancreatic neuroendocrine tumors (GEP-NETs) that have progressed following treatment with Lutetium 177-labelled somatostatin analogue (177Lu-SSA) therapy, such as 177Lu-DOTATATE or 177Lu-DOTATOC (177Lu-DOTATATE\u002FTOC), or 177Lu-high affinity \\[HA\\]-DOTATATE.",[26,27,28,29,30,31,32],[29,36,26,145,27,47,38,39,146,147,148,149,150,40,151],"targeted radiotherapy","Dotatate","Everolimus","sunitinib","octreotide","lanreotide","alpha emitter","2026-03-27",{"date":154,"type":54},"2026-03-30",{"date":156,"type":54},"2022-03-24",{"date":158,"type":20},"2030-12",{"name":60,"class":61},54,{"id":162,"slug":163,"hasResults":11,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":40,"eligibilityCriteria":167,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":168,"targetDuration":4,"studyType":73,"phases":4,"briefSummary":170,"conditions":171,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":182},"100369414","peptide-receptor-radionuclide-therapy-prrt-for-the-treatment-of-neuroendocrine-tumors-100369414","NCT04090034","Peptide Receptor Radionuclide Therapy (PRRT) for the Treatment of Neuroendocrine Tumors","Peptide Receptor Radionuclide Therapy (PRRT) for the Treatment of Neuroendocrine","Inclusion Criteria:\n\n1. \\> 18 years of age\n2. Diagnosed with gastroenteropancreatic primary NET and has consented to undergo PRRT per the treating physician. Specifically:\n\n   * Will consider other primaries on a case by case basis if dotatate scan (+) and meet all other criteria.\n   * Metastatic or Locally Advanced AND Inoperable\n   * Clear disease progression on Octreotide over less than 3 years (RECIST 1.1)\n   * Presence of disease within 24 weeks as identified by PET\u002FCT scans with Ga-68 DOTATATE reporting the Krenning score for low-grade NET and\u002For PET\u002FCT scans with FDG for transformation to high-grade NET\n   * Well differentiated on path - Ki67 \\\u003C 20%\n   * Octreotide positive on pathology (if not documented, acceptable if PET\u002FCT imaging shows lesions with Ga-68 DOTATATE uptakeLabs:\n\n     * Cr. \\\u003C1.7\n     * Hgb \\>8\n     * WBC \\>2K\n     * Plt \\>75K\n     * Bili \\\u003C 3x normal limit\n   * No Octreotide within 30 days of administration.\n3. Willing and able to comply with the protocol requirements\n4. Able to comprehend and sign the Informed Consent Form in English.\n\nExclusion Criteria:\n\n* Do not meet the Study Inclusion Criteria laid out in section 6.3",{"count":169,"type":20},50,"The specific aim is of this study is to gain a better understanding of the patient characteristics, treatment responses, survival outcomes, and adverse events associated with PRRT in patients with gastroenteropancreatic primary NETs.",[29,27],"2026-03-18",{"date":174,"type":54},"2026-03-20",{"date":176,"type":54},"2024-03-28",{"date":178,"type":20},"2026-06-28",{"name":180,"class":181},"Methodist Health System","OTHER",2,{"id":184,"slug":185,"hasResults":11,"nctId":186,"briefTitle":187,"officialTitle":187,"acronym":188,"eligibilityCriteria":189,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":190,"enrollmentInfo":191,"targetDuration":4,"studyType":73,"phases":4,"briefSummary":193,"conditions":194,"keywords":195,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":206,"locationsCount":208},"100616168","nutritional-status-assessment-in-adult-patients-followed-for-gastroenteropancreatic-neuroendocrine-tumors-at-strasbourg-university-hospital-100616168","NCT07302100","Nutritional Status Assessment in Adult Patients Followed for Gastroenteropancreatic Neuroendocrine Tumors at Strasbourg University Hospital","DENUTNE","Inclusion Criteria:\n\n* Adults aged 18 to 70 years\n* Patients being monitored for a digestive neuroendocrine tumor (gastric, pancreatic, intestinal), diagnosed between January 1, 2000, and November 30, 2024\n\nExclusion Criteria:\n\n\\- Tumor reclassified as non-neuroendocrine by histopathology","70 Years",{"count":192,"type":20},100,"Neuroendocrine tumors represent a heterogeneous group of tumors, of which gastrointestinal (gastroenteropancreatic) NETs are the most frequent.\n\nTherapeutic management involves several approaches: control of any secretory syndrome and tumor control. Surgery is the first-line treatment for localized stages. When there is distant metastasis, various systemic treatments can be combined or administered sequentially (somatostatin analogs, everolimus, sunitinib, radioablation, targeted internal radiotherapy, cytotoxic chemotherapy). Gastrointestinal NETs are most often well-differentiated and slow-growing tumors with a median overall survival of up to 9 years (all sites combined), making comprehensive management of these patients all the more important.\n\nIn the context of cancer management, malnutrition has been shown to be associated with a poorer prognosis. Similarly, addressing malnutrition and improving nutritional parameters have been associated with improved prognosis.\n\nThe impact of nutritional status in patients with slow-growing tumors such as gastrointestinal neuroendocrine tumors (NETs) is less well understood but could be a modifiable factor for improving quality of life and treatment efficacy.\n\nThe research hypothesis is that nutritional status is associated with the prognosis of patients with gastrointestinal NETs.",[27],[27,196,197,198],"Neuroendocrine tumors","Gastroenteropancreatic","Gastrointestinal","2025-12-11",{"date":201,"type":54},"2025-12-24",{"date":203,"type":54},"2024-12-12",{"date":205,"type":20},"2026-02",{"name":207,"class":181},"University Hospital, Strasbourg, France",1,{"id":210,"slug":211,"hasResults":11,"nctId":212,"briefTitle":213,"officialTitle":213,"acronym":214,"eligibilityCriteria":215,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":216,"targetDuration":4,"studyType":21,"phases":218,"briefSummary":220,"conditions":221,"keywords":222,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":224,"lastUpdatePostDateStruct":225,"startDateStruct":227,"completionDateStruct":229,"leadSponsor":231,"locationsCount":233},"100535813","multi-modal-characterisation-of-gastroenteropancreatic-neuroendocrine-tumours-gep-nets-treated-with-targeted-radionuclide-therapy-trt-prospective-interventional-multicentre-national-cohort-100535813","NCT06256705","Multi-modal Characterisation of Gastroenteropancreatic Neuroendocrine Tumours (GEP-NETs) Treated With Targeted Radionuclide Therapy (TRT): Prospective Interventional Multicentre National Cohort","OPERANDI-NET","Inclusion Criteria:\n\n* According the MDT decision to refer to PRRT\n\n  1. Histologically confirmed diagnosis of unresectable GEP-NETs whatever the grade or NETs of unknown primary but suspected of GEP origin\n  2. Metastastic and progressive according RECIST 1.1 criteria\n  3. At least 1 measurable site of disease per RECIST v1.1 using contrast-enhanced CT or magnetic resonance imaging\n  4. SSTR+ disease, as evidenced by PET-DOTATOC performed within 4 months prior to inclusion (lesion uptake greater than liver physiological uptake)\n  5. The majority of the lesions and all RECIST 1.1 selected target lesion have to be SSTR+.\n* Karnofsky performance status scale ≥ 60\n* Live expectancy \\>6 months\n* Patients ≥ 18 years of age\n\nExclusion Criteria:\n\n* Known pregnancy or breastfeeding women\n* Known hypersensitivity to 177Lu, octreotate, DOTA, 68Ga, Edotreotide,\n* Known hypersensitivity to lysine, arginine, or any excipient of the nephroprotective amino acid solution (AAS) given concomitantly to the 177Lu-DOTATATE infusion.\n* Contraindication to MRI and technical impossibility of MRI\n* Prior external beam radiation therapy (EBRT) of GEP-NET lesions or liver selective internal radiation therapy within 12 weeks before inclusion, if extensive\n* Other systemic antitumor treatment (non-radioactive, excluding somatostatin analogues) not interrupted for at least 4 weeks\n* Mixed Neuroendocrine-Non-endocrine Neoplasms (MiNEN)\n* Neuroendocrine carcinoma\n* Uncontrolled brain metastasis for at least 3 months\n* NYHA 3 or 4 heart failure\n* Inability to discontinue delayed-acting somatostatin analogues at least 28 days prior the PRRT or rapid-acting somatostatin analogues at least 24 hours prior the PRRT\n* Non-adequate bone marrow, liver and renal function within 1 month prior the PRRT as assessed by the following laboratory tests:\n\n  * Platelet count \\\u003C 75,000\u002Fmm3\n  * Haemoglobin ≤ 8,0 g\u002FdL\n  * Total bilirubin \\> 3 ULN\n  * Neutrophils \\\u003C 1000\u002Fmm3\n  * Prothrombin time \\\u003C 70% unless albumin \\> 30g\u002FL\n  * Albumin \\\u003C30g\u002FL unless prothrombin time \\> 70 %\n  * Glomerular Filtration Rate (GFR) \\\u003C 35 mL\u002Fmin\u002F1.73 m2\n* Prior peptide receptor radionuclide therapy (PRRT)\n* Other progressive cancer excluding in situ cervical cancer and basal or squamous cell skin cancer within the last 3 years\n* Patient refusal to give written informed consent\n* Subject deprived of freedom, subject under a legal protective measure\n* No affiliation to a social security regimen or CMU\n* Patient under State Medical Aid",{"count":217,"type":20},80,[219],"NA","Operandi project aims to address unmet clinical needs in the current management of GEP-NETs treated with PRRT by exploring new opportunities provided by imaging-based (AI algorithms) and data augmentation, simultaneous 68Ga-DOTATOC PET-MRI imaging, and novel approaches to increase patient selection and PRRT efficacy (genomic profiling, radiopotentiators, and new radionuclides). The study aim to identify predictive and early markers indicative of PRRT effectiveness based on a large prospective cohort of GEP-NET patients. This cohort will be used to uncover relevant predictive signatures within the morphological, functional, and molecular imaging data using novel imaging-based AI approaches with a new patient imaging pathway including simultaneous 68Ga-DOTATOC PET-MRI.\n\nConsidering this global objective, the objective of this clinical research protocol is to provide clinical, molecular and imaging data in a prospective standardized study, notably by performing systematic PET-MRI at baseline, at mid course of PRRT and 1 year after PRRT initiation, in patients with advanced GEP-NETs treated with PRRT.",[27,116],[223],"Targeted radionuclide therapy","2025-09-18",{"date":226,"type":54},"2025-09-22",{"date":228,"type":54},"2024-03-25",{"date":230,"type":20},"2029-09-25",{"name":232,"class":181},"Assistance Publique - Hôpitaux de Paris",5,{"id":235,"slug":236,"hasResults":11,"nctId":237,"briefTitle":238,"officialTitle":239,"acronym":4,"eligibilityCriteria":240,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":241,"targetDuration":4,"studyType":21,"phases":242,"briefSummary":243,"conditions":244,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":246,"startDateStruct":248,"completionDateStruct":250,"leadSponsor":252,"locationsCount":208},"100409292","phase-1-study-of-prrt-in-metastatic-world-health-organization-who-grade-1-or-2-sstr-positive-gep-net-who-are-candidates-for-cytoreductive-surgery-100409292","NCT04609592","Study of PRRT in Metastatic, World Health Organization (WHO) Grade 1 or 2, SSTR Positive, GEP-NET Who Are Candidates for Cytoreductive Surgery","Pilot Phase 1 Study of Perioperative Peptide Receptor Radionuclide Therapy (PRRT) in Metastatic, WHO Grade 1 or 2, SSTR Positive, Gastroenteropancreatic Neuroendocrine Tumors Who Are Candidates for Cytoreductive Surgery","Inclusion Criteria:\n\n1. Metastatic gastroenteropancreatic NET with lymph nodes or liver metastases only.\n2. WHO Grade 1 or 2, Ki 67 ≤ 20% (to be confirmed at Stanford)\n3. Must be a candidate for cytoreductive surgery with the goal of R1 resection as determined by a multidisciplinary tumor board discussion\n4. Measurable disease as determined by RECIST v1.1\n5. Confirmed presence of somatostatin receptors on all target lesions as determined by 68Ga DOTA TATE PET scan\n6. Patients ≥ 18 years of age.\n7. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1\n8. Appropriate hematologic, liver and kidney function\n9. Patients on octreotide long-acting release (LAR) at a fixed dose of 20 mg or 30 mg at 3 to 4 weeks intervals for at least 12 weeks prior to enrollment in the study\n\nExclusion Criteria:\n\n1. Prior 177Lu Dotatate treatment\n2. Any surgery or radiofrequency ablation within 12 weeks prior to enrollment in the study; or prior radioembolization; chemoembolization; or external beam radiation therapy (EBRT) to \\> 25% of bone marrow, at any time\n3. Any chemotherapy or targeted therapy (including everolimus and sunitinib) within 4 weeks prior to enrollment in the study\n4. Known brain metastases\n5. Known bone or peritoneal metastases",{"count":5,"type":20},[23],"The purpose of this study is to learn about the feasibility and safety of using Peptide Receptor Radionuclide Therapy (PRRT) before and after surgical removal of a tumor. PRRT treatment is based on the administration of a radioactive product, 177-Lu DOTA-0-Tyr3-Octreotate (Lutathera®) and its use before and after surgery is thought to increase the overall survival benefit for patients with SSTR-positive gastroenteropancreatic neuroendocrine tumors GEP-NETs.",[27],"2025-09-08",{"date":247,"type":54},"2025-09-09",{"date":249,"type":54},"2021-03-17",{"date":251,"type":20},"2027-09",{"name":253,"class":181},"Stanford University",{"id":255,"slug":256,"hasResults":11,"nctId":257,"briefTitle":258,"officialTitle":259,"acronym":260,"eligibilityCriteria":261,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":262,"targetDuration":4,"studyType":21,"phases":264,"briefSummary":266,"conditions":267,"keywords":268,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":271,"lastUpdatePostDateStruct":272,"startDateStruct":274,"completionDateStruct":276,"leadSponsor":278,"locationsCount":129},"100493137","phase-4-continuing-somatostatin-analogues-upon-progression-in-neuroendocrine-tumour-patients-100493137","NCT05701241","Continuing Somatostatin Analogues Upon Progression in Neuroendocrine Tumour pAtients","Continuing Somatostatin Analogues Upon Progression in Neuroendocrine Tumour pAtients - The SAUNA Trial","SAUNA","Inclusion Criteria:\n\n* Age ≥18 years\n* Written informed consent prior to any study-related procedures\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤2,\n* Histologically-proven diagnosis of locally advanced or metastatic, non-functional, well-differentiated World Health Organisation 2019 grade 1-2 GEP NET\n* Documented radiological disease progression on first-line SSA treatment at label dose or higher\n* For targeted therapy substudy: indication to start with either sunitinib or everolimus as second-line therapy, according to local investigator\n* For PRRT substudy: indication to start with PRRT with Lutetium (177Lu) oxodotreotide as second-line therapy, according to local investigator\n\nExclusion Criteria:\n\n* Indication for chemotherapy treatment of GEP NET in second-line\n* Presence of poorly differentiated grade 3 neuroendocrine carcinoma (NEC), well-differentiated grade 3 NET or rapidly progressive NET\n* Prior treatment with everolimus, sunitinib or PRRT\n* Contra-indication, proven allergy or other indication than functional NET for the use of a SSA\n* Patient showing progressive disease while being on a lower than the registered dose\n* Functional NET, defined as the presence of clinical and biochemical evidence of a hormonal NET-related syndrome\n* Patient undergoing palliative, systemic oncological treatment for other malignancy than GEP NET\n* Concurrent anti-cancer treatment in another investigational trial\n* Any abnormal findings at screening, clinical finding, including psychiatric and behavioural problems, or any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardize the patient's safety or decrease the chance of obtaining satisfactory data needed to achieve the objective(s) of the study\n* Pregnant or lactating patient at screening or if the patient wishes to get pregnant during treatment phase of the trial",{"count":263,"type":20},270,[265],"PHASE4","The SAUNA trial is a multi-national, multi-centre, open-label, randomised, controlled, pragmatic clinical trial in patients with advanced, non-functional gastroenteropancreatic (GEP) neuroendocrine tumours (NET) with progressive disease on first-line therapy with somatostatine analogues (SSA). Eligible patients will be divided into two substudies according to the second-line therapy of choice (peptide receptor radionuclide therapy (PRRT) or targeted therapy, at the discretion of the local investigator). Patients within each substudy will be randomised 1:1 between continuation or withdrawal from SSA at the start of second-line systemic therapy. Stratification will occur according to study site and according to the Ki67 value (below 10% (grade 1 and low grade 2) and equal to or above 10% (high grade 2)).",[27],[269,270],"somatostatin analogues","neuroendocrine tumor","2024-06-13",{"date":273,"type":54},"2024-06-14",{"date":275,"type":54},"2023-06-28",{"date":277,"type":20},"2034-04",{"name":279,"class":181},"University Hospital, Antwerp",{"id":281,"slug":282,"hasResults":11,"nctId":283,"briefTitle":284,"officialTitle":284,"acronym":4,"eligibilityCriteria":285,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":286,"targetDuration":4,"studyType":73,"phases":4,"briefSummary":287,"conditions":288,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":289,"lastUpdatePostDateStruct":290,"startDateStruct":292,"completionDateStruct":294,"leadSponsor":296,"locationsCount":208},"100528019","68ga-dotatoc-pet-for-the-evaluation-of-gastroenteropancreatic-neuroendocrine-tumours-100528019","NCT06155318","68Ga-DOTATOC PET for the Evaluation of Gastroenteropancreatic Neuroendocrine Tumours","Inclusion Criteria:\n\n* Patients with either histological diagnosis of GEP-NET at radiologic imaging and referred to 68Ga-DOTATOC PET;\n* Age \\> 18 years old;\n* Willing to provide a signed informed consent.\n\nExclusion Criteria:\n\n* Controindications to MR study (i.e. Pacemaker);\n* Age\\\u003C 18 years old.",{"count":98,"type":20},"Gastroenteropancreatic neuroendocrine tumours (GEP-NETs) are a heterogeneous group of neoplasms that arise from the endocrine cells of the gastroenteropancreatic tract.\n\nThe diagnostic work-up of these tumours include Computed Tomography (CT), Endoscopic Ultrasound (EUS), Magnetic Resonance Imaging (MRI).\n\nThe majority of these tumours express somatostatin receptors on their surface. For this reason, in addition to traditional imaging exams, diagnostic work-up of GEP-NETs should include a Positron Emission Tomography\u002FCT with 68Ga labeled somatostatin analogues targeting somatostatin receptors with high sensitivity and specificity. 68Ga-DOTATOC PET\u002FCT scan is a corner stone to assess GEP- NET patients at different stage of disease and it is the standard functional imaging modality to study well-differentiated Pan-NETs, as reported in the being also included in the guidelines of the European Association of Nuclear Medicine (EANM). Moreover, quantitative parameters extracted from 68Ga- DOTA-peptides PET imaging have demonstrated their prognostic utility as markers for progression-free survival and disease specific mortality in patients affected by NET.\n\nAdditionally, 18F-FDG PET can be used for evaluating the possible presence ofa high-grade component within the tumour itself. The accurate morphofunctional characterization is of utmost importance in the field of GEP-NET.\n\nthe advent of new hybrid scanners, namely PET\u002FMRI, opens the way to an innovative diagnostic work- up that can be applied to GEP-NETs. In fact, MRI plays a role as morphological imaging modalities for a better characterization of soft-tissue and liver parenchyma compared to CT; moreover, the low radiation exposure related to MRI, makes this imaging modality more suitable for patients requiring several imaging during follow-up.\n\nPatients requiring 68Ga-DOTA peptides (68Ga-DOTATOC) PET scan and eventually MRI scan, can be studied in a single session examination, by using 68Ga-DOTATOC PET\u002FMRI.\n\nConsidering the rarity of GEP\\_NETs, it is quite difficult to collect a sufficient number of patients in order to investigate the accuracy, predictive and prognostic value of the currently available imaging technique in this scenario. Based on these considerations, the possibility to analyze PET images deriving from both PET\u002FCT and PET\u002FMRI scans of patients affected by GEP-NET is of fundamental relevance in order to provide answers to the currently unmet clinical needs.",[27],"2023-12-13",{"date":291,"type":54},"2023-12-20",{"date":293,"type":54},"2019-09-05",{"date":295,"type":20},"2029-05-05",{"name":297,"class":181},"IRCCS San Raffaele"]