[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"neuroendocrine-tumor-grade-1\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:neuroendocrine-tumor-grade-1":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,45,75,105,132],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100546474","phase-2-177lu-dotatate-modified-delivery-based-on-individualized-dosimetry-100546474",false,"NCT06395402","177Lu-DOTATATE Modified Delivery Based on Individualized Dosimetry","LUMOD-ID","In order to be eligible to participate in this study, an individual must meet all of the following criteria. A physical, with vital signs, concomitant medication review, and medical history must be completed within 60 calendar days to confirm appropriateness of Lutathera treatment as well as to foundation for listed criteria.\n\nInclusion Criteria:\n\n* Provision of signed and dated informed consent form.\n* Stated willingness to comply with all study procedures and availability for the duration of the study.\n* Aged ≥ 18 years at time of consent.\n* Pathologically confirmed (histology or cytology) malignant neoplasm that is determined to be a well-differentiated neuroendocrine tumor (Ki-67 ≤ 20%) with the primary tumor location known or believed to be gastroenteropancreatic origin (GEP-NET)\n* Disease measuring ≥ 1.5 cm in diameter on CT or MRI as measured per RECIST that shows uptake \\> liver background on sstr2 PET\u002FCT with any FDA approved sstr2 imaging agent. SSTR2 PET\u002FCT must have been obtained within 90 days prior to scheduled C1D1 of Lutathera.\n* Recommended to receive LUTATHERA® therapy for unresectable and\u002For metastatic neuroendocrine disease.\n* Adequate performance status (ECOG of 0 or 1; or Karnofsky performance status of ≥70).\n* Agrees to contraception during therapy.\n* Neutrophil count within normal limits within 28 days of treatment day 1.\n* Platelet count within normal limits within 28 days of treatment day 1.\n* Ability to take oral medication and be willing to adhere to the treatment regimen\n* For individuals of reproductive potential: agreement to use effective birth control\n* Agreement to adhere to Lifestyle Considerations throughout study duration: abstain from caffeine or xanthine-containing products as well as alcohol before the start of cycle dosing and through the cycle's final blood sample; minimize social interactions during low blood counts.\n\nExclusion Criteria:\n\n* Individuals who are pregnant or lactating (note: potential participants should not engage in 'pump \\& dump' strategy; lactation must be discontinued).\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (requiring inpatient admission or a delay to start of therapy), fever, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Surgery, radiation therapy, or chemotherapy ≤ 4 weeks of C1D1 (Toxicities from prior therapies should have resolved to ≤ CTCAE grade 1 or a new baseline established).\n* Prior peptide-receptor radiotherapy (PRRT).\n* Therapeutic investigational drug within 4 weeks of C1D1 (imaging agents are acceptable).\n* A concurrent malignancy that, in the opinion of the investigator, would cause a safety risk by delaying therapy or confound\u002Fnegatively impact study objectives (documentation of the rationale must be provided)\n* Prior external beam radiation dose to the kidneys of \\>10 Gy (mean dose to functional renal volume).\n* Prior external beam radiation (including brachytherapy) involving 25% of the bone marrow (excluding scatter doses of ≤ 5 Gy) as estimated by a radiation oncologist.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to Octreoscan® or Netspot™.","ALL","18 Years",{"count":19,"type":20},120,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The goal of this study is to learn if individualized dosimetry-based prescribing of Lutetium-177 DOTATATE (Lutathera, Novartis Pharmaceuticals) improves treatment outcomes for adults with unresectable neuroendocrine tumors. To investigate this, study participants will:\n\n* Undergo Somatostatin Receptor (SSTR) positron emission tomography (PET) imaging, such as a DOTATOC PET\u002FCT scan\n* Be randomized to receive standard treatment (as per FDA guidelines) or investigational treatment (customized dosing of Lutathera based upon dosimetry)\n* Undergo blood tests for 4 to 8 weeks after each Lutathera treatment\n* Complete patient reported outcome questionnaires\n* Visit the clinic for follow-up about every 8 weeks.",[26,27,28],"Neuroendocrine Tumors","Neuroendocrine Tumor Grade 1","Neuroendocrine Tumor Grade 2",[30,31],"lutetium Lu 177 dotatate","Radiotherapy Planning, Computer-Assisted","RECRUITING","2025-07-17",{"date":35,"type":36},"2025-07-22","ACTUAL",{"date":38,"type":36},"2024-05-03",{"date":40,"type":20},"2029-12-31",{"name":42,"class":43},"University of Iowa","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":44},"100402489","pancreatic-radiofrequency-under-high-echo-endoscopy-in-the-management-of-pancreatic-neuroendocrine-tumors-100402489","NCT04520932","Pancreatic Radiofrequency Under High Echo-endoscopy in the Management of Pancreatic Neuroendocrine Tumors","Pancreatic Radiofrequency Under High Echo-endoscopy in the Management of Low Grade Pancreatic Neuroendocrine Tumors of Less Than 2cm in Size","RFANET","Inclusion Criteria:\n\n* Pancreatic mass of less than 2cm on MRI, or CT scan if contraindicated by MRI;\n* Diagnosis of neuroendocrine tumor on biopsy under high echo-endoscopy (HEE) with Ki67\\\u003C3%,\n* Non-secretory lesion.\n* Homogeneous HEE contrast taking;\n* No positron emission tomography (PET) FDG binding to the pancreatic mass;\n* Lesion \\\u003C20mm on conventional imaging at 6 months monitoring;\n* Age 18 to 80 years inclusive;\n* Patient in good general condition, World Health Organization \\[0-1\\];\n* Signed consent to participate;\n* Affiliation to healthcare insurance system or beneficiary of this regimen.\n\nExclusion Criteria:\n\n* Pregnant or likely to become pregnant (without effective contraception) or breastfeeding ;\n* A person in an emergency situation or deprived of liberty or placed under the authority of a tutor.\n* Life expectancy \\\u003C 1 year;\n* Severe hemostasis disorders;\n* Pancreatic and\u002For biliary ductal dilation;\n* Lesion considered to be adjacent to the pancreatic duct and\u002For bile duct;\n* Node extension and\u002For metastatic disease;\n* Patient being managed for another malignant lesion which is progressive or under treatment.","80 Years",{"count":55,"type":20},82,[57],"NA","Pancreatic radiofrequency ablation (RFA) could therefore be an alternative to the monitoring of pancreatic neuroendocrine tumors (PNETs) and more particularly nonfunctioning PNETs (NF-PNETs), which is costly and anxiety-inducing for patients. To date, only a few small studies have evaluated this treatment and the results are encouraging. It appears necessary to consider a large-scale study to ensure the efficacy and low morbidity of pancreatic RFA applied to PNETs.",[60,27],"Neuroendocrine Tumor of Pancreas (Disorder)",[62,63,64,65],"Radio Frequency treatment","Echoendoscopy","Ablation","Efficacy","2025-05-23",{"date":68,"type":36},"2025-05-25",{"date":70,"type":36},"2021-03-30",{"date":72,"type":20},"2031-04",{"name":74,"class":43},"Institut Paoli-Calmettes",{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":53,"enrollmentInfo":83,"targetDuration":4,"studyType":85,"phases":4,"briefSummary":86,"conditions":87,"keywords":90,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":44},"100398130","rediscovering-biomarkers-for-the-diagnosis-and-early-treatment-response-in-nen-reborn-100398130","NCT04464122","Rediscovering Biomarkers for the Diagnosis and Early Treatment Response in NEN (REBORN)","Rediscovering Biomarkers for the Diagnosis and Early Treatment Response in NEN. REBORN Study","REBORN","Inclusion Criteria:\n\n* Histologically-proven NENs, locally advanced or metastatic, originating from pulmonary or gastro-entero-pancreatic (GEP) tract, candidate to first line medical therapy (study group);\n* Patients affected by other non-malignant endocrine disease, e.g. benign thyroid disfunction (control group).\n\nExclusion Criteria:\n\n* Severe chronic kidney disease (stage 4-5);\n* Clinical or laboratory signs of significant respiratory, cardiological and hepatobiliary disease;\n* Other non-neuroendocrine malignancies.",{"count":84,"type":20},60,"OBSERVATIONAL","This is a multicentre, controlled, observational prospective study on new biomarkers, as immune profiling, angiogenetic markers and circRNA from TEPs in the diagnosis and in the evaluation of treatment response in pulmonary and gastro-entero-pancreatic NENs.",[26,88,27,28,89],"Neuroendocrine Neoplasm","Neuroendocrine Carcinoma",[91,92,93,94,95],"Neuroendocrine Tumours","Prognostic markers","Tumour educated platelets","angiogenesis","immune function","2025-03-31",{"date":98,"type":36},"2025-04-03",{"date":100,"type":36},"2020-09-14",{"date":102,"type":20},"2025-12-31",{"name":104,"class":43},"University of Roma La Sapienza",{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":109,"acronym":110,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":112,"targetDuration":4,"studyType":21,"phases":114,"briefSummary":116,"conditions":117,"keywords":118,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":44},"100581806","phase-2-absorbed-tumor-dose-in-peptide-receptor-radionuclide-therapy-with-long-acting-somatostatin-analogues---atsa-trial-100581806","NCT06855095","Absorbed Tumor Dose in Peptide Receptor Radionuclide Therapy with Long-acting Somatostatin Analogues - ATSA Trial","ATSA","Inclusion Criteria:\n\n* Age ≥ 18 years;\n* Able to provide spoken and written informed consent for the trial;\n* Histopathological confirmed neuroendocrine tumor;\n* Fulfill the clinical criteria for PRRT;\n* At least one soft tissue lesion \\> 2 cm;\n* Aimed administered activity of 7400 MBq;\n* ECOG score (performance status) 0-2.\n\nExclusion Criteria:\n\n* Not possible to discontinue LA-SSA for 4-6 weeks;\n* Use of short-acting SSAs;\n* Pregnancy and lactating female patients;\n* Inability to comply to the study procedures;\n* Factors that might affect the biodistribution (for example, indication for furosemide directly after PRRT infusion, limited fluid intake, any renal catheters, etc.).",{"count":113,"type":20},39,[23,115],"PHASE3","According to current guidelines, patients have to withhalt long-acting somatostatin analogues (LA-SSA) for 4-6 weeks prior to every 177Lutetium-DOTATATE administration. The primary objective of the study is to investigate the effect of LA-SSA on the absorbed dose in tumor lesions during PRRT.",[26,27,28,88],[119,120,121,122],"Peptide Receptor Radionuclide Therapy","PRRT","Lutetium","DOTATATE","2025-02-26",{"date":125,"type":36},"2025-03-03",{"date":127,"type":36},"2024-06-25",{"date":129,"type":20},"2027-03-01",{"name":131,"class":43},"The Netherlands Cancer Institute",{"id":133,"slug":134,"hasResults":11,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":138,"eligibilityCriteria":139,"healthyVolunteers":11,"sex":16,"minAge":140,"maxAge":4,"enrollmentInfo":141,"targetDuration":4,"studyType":21,"phases":143,"briefSummary":144,"conditions":145,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":158},"100552384","phase-2-everolimus-5-mg-vs-10-mgdaily-for-patients-with-neuroendocrine-tumors-100552384","NCT06472388","Everolimus 5 mg vs 10 mg\u002FDaily for Patients With Neuroendocrine Tumors","Randomized Phase II Trial of Everolimus 5 mg vs 10 mg\u002FDaily for Patients With Advanced Neuroendocrine Tumors","EVENET","Inclusion Criteria:\n\n* Histological confirmation of well-differentiated Grade 1\u002FGrade 2 NET from gastrointestinal, pancreatic, pulmonary or unknown primary sites.\n* Metastatic or locally advanced and unresectable disease, measurable by images\n* Disease progression by RECIST 1.1 in the last 6 months assessed by local investigators\n* At least one previous line of systemic treatment (suspended for more than 3 weeks).\n* Eastern Cooperative Oncology Group (ECOG) 0-2 o Good organ function:\n\n  * Hemoglobin \\> 8 g\u002FdL\n  * Neutrophils ≥ 1,500\u002Fmm³\n  * Platelets \\> 90,000\u002Fmm³\n  * Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 2.5 x ULN \\[upper limit of normal\\] or ≤ 5 x ULN for patients with liver metastases\n  * Bilirubin ≤ 1.5 x ULN, creatinine \\\u003C 1.5 mg\u002FdL\n\nExclusion Criteria:\n\n* Aggressive disease requiring cytotoxic therapy\n* Severe\u002Funcontrolled comorbid conditions that deem participant unfit for everolimus therapy, as per investigators' judgement.\n* MiNEN","16 Years",{"count":142,"type":20},100,[23],"Everolimus is approved in many countries to treat patients with advanced\u002Fmetastatic well-differentiated neuroendocrine tumors (NET), providing median progression-free survival times of approximately 12 months across different types of NET. However, it is can cause severe adverse effects. Phase I trial demonstrated that a dose of 5mg\u002Fday\u002Fweek was sufficient to inhibit cell proliferation by blocking the mTOR pathway.\n\nThis is a randomized, open-label, phase II near-equivalence clinical trial of oral everolimus 5 mg vs 10 mg oral\u002Fdaily and continuously in patients with Grade 1 or Grade 2 metastatic NET, with tumor progression or intolerance to at least one line of treatment and with radiological disease progression within 6 months.",[26,146,27,28,147,148,149],"Progression","Neuroendocrine Tumor of Pancreas","Neuroendocrine Tumor of the Lung","Neuroendocrine Tumor Carcinoid","2024-06-18",{"date":127,"type":36},{"date":153,"type":36},"2024-04-24",{"date":155,"type":20},"2026-12-31",{"name":157,"class":43},"AC Camargo Cancer Center",2]