[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"carcinoid\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:carcinoid":24},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,45,86,131],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":25,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":4,"leadSponsor":41,"locationsCount":44},"100106168","natural-history-of-familial-carcinoid-tumor-100106168",false,"NCT00646022","Natural History of Familial Carcinoid Tumor","* INCLUSION CRITERIA:\n\nThere are four types of participants who will be included in this protocol as outlined below.\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria for their group:\n\nGroup 1 (Arm 1 or Arm 2)\n\n* Male and female subjects \\>= 18 years of age\n* Have a diagnosis of small intestinal carcinoid tumor\n* Have at least one blood relation with a diagnosis of either small intestinal, pulmonary, kidney or gastropancreatic neuroendocrine tumor or metastatic neuroendocrine tumor of unknown primary\n\nGroup 2 (Arm 1 or Arm 2)\n\n* Male and female subjects \\>= 18 years of age\n* Has multiple synchronous primary small intestinal tumors\n\nGroup 3 (Arm 1 or Arm 2)\n\n* Male and female subjects \\>=18 years of age\n* Does not have a diagnosis of carcinoid tumor\n* Has one of the following:\n\n  * at least two blood relatives with any combination of diagnoses of small intestinal carcinoid tumor, a pulmonary, kidney, gastropancreatic neuroendocrine tumor or metastatic neuroendocrine tumor of unknown primary OR\n  * has at least one blood relative with multiple, synchronous primary small bowel tumors\n\nGroup 4 (Arm 2 only)\n\n* Male and female subjects \\>= 18 years of age\n* Not biologically related to the participating family but has offspring who is\u002Fare blood relative(s) of a participating subject.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this\n\nstudy:\n\n1. Members of families with multiple endocrine neoplasia (MEN) I, MEN II or other familial tumor syndromes such as Von Hippel Lindau Syndrome and Neurofibromatosis type I and type II for which there is a known genetic predisposition to non-carcinoid tumors as well as\n\n   carcinoid tumors will be excluded from the study.\n2. Any condition which, in the opinion of the investigator, would make it unsafe to participate or would prohibit completion of the protocol.\n3. Inability to provide informed consent (Arm 1 only)\n4. Pregnant or breastfeeding (Arm 1 only)","ALL","18 Years","100 Years",{"count":19,"type":20},1600,"ESTIMATED","OBSERVATIONAL","This study will evaluate members in families with a history of small bowel carcinoid cancer to study the natural history of those family members that have the disease, determine ways to improve early detection by performing surveillance on those at risk but without disease and to identify the gene(s) that may cause the tumors. Familial carcinoid tumors usually originate in hormone-producing cells that line the small intestine or other cells of the digestive tract. The tumors are slow-growing and usually take many years before they cause symptoms. It is known that these tumors occur more often in some families and are then passed from one generation to the next by inherited genes.\n\nMembers of families, including all siblings and offspring in which two or more immediate blood relatives have had small bowel carcinoid tumors are eligible for this study. In some cases unaffected spouses of family members diagnosed with carcinoid cancer are also requested to participate by donating a sample of blood only.\n\nParticipants undergo a medical evaluation every 3 years during a 3- to 5-day hospital stay at the NIH Clinical Center. All participants have a personal and family medical history obtained and undergo a physical examination, blood and urine tests.\n\nPeople who already have a small bowel carcinoid tumor or are at risk of developing a carcinoid tumor have some or all of the following procedures to determine the presence of carcinoid tumor and its (omit next two words- location or) spread to other areas of the body:\n\n* Video Capsule Endoscopy: Visualization of the gastrointestinal tract by ingesting a disposable, \"vitamin-pill sized\" video capsule that has its own camera and light source.\n* CT of the chest abdomen and pelvis with oral and IV contrast : X-ray examination of the chest, abdominal and pelvis organs.\n* 18 FDOPA Positron emission tomography (PET) with CT for localization: Nuclear imaging scan to look at tumor activity.\n* MRI Liver with contrast - to determine if disease has spread to liver\n* Gallium 68 PET\u002FCT-limited to individuals that have residual tumor.\n* Clinical and research blood work\n\nShould mid gut carcinoid tumors be found every participant will be assisted in determine what the best course of treatment will be for them.",[24],"Carcinoid",[26,27,28,29,30,31,32,33],"Neuroendocrine","PET","Gastrointestinal","Serotonin","Natural History","Carcinoid Tumor","Gastrointestinal Carcinoid Tumor","Familial Cancer Tumor","RECRUITING","2026-06-27",{"date":37,"type":38},"2026-06-30","ACTUAL",{"date":40,"type":38},"2008-08-25",{"name":42,"class":43},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","NIH",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":67,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":85},"100599635","phase-3-carcinoid-syndrome-efficacy-study-featuring-an-oral-daily-paltusotine-regimen-100599635","NCT07087054","Carcinoid Syndrome Efficacy Study Featuring an Oral Daily Paltusotine Regimen","A Randomized, Parallel Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Paltusotine in Adults With Carcinoid Syndrome Due to Well-Differentiated Neuroendocrine Tumors","CAREFNDR","Inclusion Criteria:\n\n* Male or female ≥18 years of age, at the time of Screening.\n* Willing and able to comply with the study procedures as specified in the protocol, including at least 70% compliance with the study diary for the 2-week period.\n* Documented carcinoid syndrome requiring medical therapy. Participants must exhibit symptoms of flushing with or without frequent BMs as follows:\n\n  * For participants who are naïve\u002Fnot currently treated with somatostatin receptors ligands (SRL), they must exhibit an average of \\>1 flushing episode\u002Fday over a period of 14 days\n  * For participants who will wash out from SRL treatment, they must be symptomatically controlled and exhibit an increase in daily average flushing episodes and an average of \\>1 flushing episode\u002Fday over a period of 14 days during the Washout Period.\n* Evaluable documentation of locally advanced or metastatic histopathologically confirmed well-differentiated neuroendocrine tumor(s) \\[NETs\\].\n* No significant disease progression as assessed by the Investigator within the last 6 months before randomization.\n\nExclusion Criteria:\n\n* Diarrhea attributed to any condition(s) other than carcinoid syndrome.\n* Uncontrolled\u002Fsevere diarrhea associated with significant volume contraction, dehydration, or hypotension.\n* Requires second line treatments (eg, telotristat) for control of carcinoid syndrome symptoms in the opinion of the Investigator.\n* Treatment with specific NET therapy \\\u003C4 weeks before Screening (such as everolimus or sunitinib) or hepatic embolization, radiotherapy, peptide receptor radionuclide therapy (PRRT), and\u002For tumor debulking \\\u003C12 weeks before Screening.\n* Major surgery within 8 weeks before Screening.\n* History of another primary malignancy \\\u003C3 years prior to the date of randomization, except for adequately treated basal or squamous cell carcinoma of the skin, cancer of the breast has been completely locally excised and carcinoma in situ of the cervix has also been resected, previously treated malignancy, if all treatment for that malignancy was completed at least 3 years prior to first dose of study treatment, and no current evidence of disease, concurrent malignancy determined to be clinically stable and not requiring treatment.\n* Diabetes mellitus treated with insulin for less than 6 weeks prior to the study entry.\n* Poorly controlled diabetes mellitus defined as having a hemoglobin A1c (HbA1c) ≥8.5%\n* Unable to administer short-acting (SA) octreotide (octreotide acetate injection), or prior nonresponse documented with somatostatin agonists.\n* Clinically significant concomitant disease or indicator of disease that is not a result of the primary disease under study, including but not limited to cardiovascular disease, estimated glomerular filtration rate 2×upper limit of normal \\[ULN\\], and\u002For total bilirubin (TB) \\>1.5×ULN. (Participants with previously diagnosed Gilbert's syndrome not accompanied by other hepatobiliary disorders and associated with TB\n* Alcohol or drug abuse is not permitted at any time during the study\n* Diagnosed with symptomatic cholelithiasis",{"count":54,"type":20},141,"INTERVENTIONAL",[57],"PHASE3","A Phase 3, randomized, double-blinded, placebo-controlled study to evaluate the efficacy and safety of paltusotine treatment vs placebo as well as the long-term safety of paltusotine in adults with carcinoid syndrome due to well-differentiated neuroendocrine tumors. The purpose of this study is to continue the evaluation of the safety, efficacy, and pharmacokinetics (PK) of paltusotine in participants with carcinoid syndrome.",[60,24,31,61,62,63,64,65,66],"Carcinoid Syndrome","Carcinoid Tumor of Ileum","Carcinoid Tumor of Cecum","Carcinoid Tumor of Liver","Carcinoid Tumor of Pancreas","Carcinoid Syndrome Diarrhea","Carcinoid Intestine Tumor",[68,69,70,71,72,73,74],"Neuroendocrine tumor","Paltusotine","CRN00808","Carcinoid syndrome","Lanreotide","Octreotide","Somatostatin agonist","2026-06-23",{"date":77,"type":38},"2026-06-25",{"date":79,"type":38},"2025-11-19",{"date":81,"type":20},"2030-01",{"name":83,"class":84},"Crinetics Pharmaceuticals Inc.","INDUSTRY",51,{"id":87,"slug":88,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":4,"eligibilityCriteria":92,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":93,"targetDuration":4,"studyType":55,"phases":95,"briefSummary":97,"conditions":98,"keywords":106,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":130},"100605639","phase-1-study-of-ryz401-in-subjects-with-solid-tumors-expressing-sstrs-100605639","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",{"count":94,"type":20},104,[96],"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.",[99,100,101,102,24,31,103,104,105],"GEP-NET","Gastroenteropancreatic Neuroendocrine Tumor","Gastroenteropancreatic Neuroendocrine Tumor Disease","Neuroendocrine Tumors","Pancreatic NET","Solid Tumor","Somatostatin Receptor",[102,107,99,108,100,109,110,111,104,112,113,114,115,116,117,118,119,120],"SSTR+","Targeted Radiotherapy","Actinium","Ac 225","PRRT","Somatostatin Receptors","Radiopharmaceutical","BMS","Bristol Myers Squibb","Rayze","SSTR","RayzeBio","Well-differentiated NET","WD NETs","2026-06-08",{"date":123,"type":38},"2026-06-09",{"date":125,"type":38},"2025-12-03",{"date":127,"type":20},"2033-04",{"name":129,"class":84},"RayzeBio, Inc.",9,{"id":132,"slug":133,"hasResults":11,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":137,"eligibilityCriteria":138,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":139,"targetDuration":4,"studyType":55,"phases":141,"briefSummary":142,"conditions":143,"keywords":144,"overallStatus":34,"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":140,"type":20},338,[57],"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.",[99,100,101,102,24,31,103],[102,107,99,145,100,118,109,110,146,147,148,149,150,111,151],"targeted radiotherapy","Dotatate","Everolimus","sunitinib","octreotide","lanreotide","alpha emitter","2026-03-27",{"date":154,"type":38},"2026-03-30",{"date":156,"type":38},"2022-03-24",{"date":158,"type":20},"2030-12",{"name":129,"class":84},54]