[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100409292":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":49,"centralContacts":54,"locations":62,"responsibleParty":80,"collaborators":82,"id":86,"slug":87,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":43,"eligibilityCriteria":92,"healthyVolunteers":88,"sex":93,"minAge":94,"maxAge":43,"enrollmentInfo":95,"targetDuration":43,"studyType":98,"phases":99,"briefSummary":101,"conditions":102,"keywords":43,"overallStatus":65,"whyStopped":43,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"Stanford University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Lutathera","EXPERIMENTAL","2 cycles of 177Lu Dotatate, followed by cytoreductive surgery, followed by additional 177Lu Dotatate (up to 2 cycles) for residual disease as determined by 68Ga DOTA TATE PET\u002FCT",[13,14,15,16,17],"Drug: Lutathera","Drug: Gallium 68 Dotatate","Procedure: Computed Tomography (CT)","Procedure: Magnetic Resonance Imaging (MRI)","Procedure: PET\u002FCT",[19,27,33,40,44],{"type":20,"name":9,"description":21,"armGroupLabels":22,"otherNames":23},"DRUG","4 administrations of 7.4 gigabecquerel (GBq) (200 mCi) 177Lu Dotatate +\u002F 10% at the date and time of infusion, accumulative dose of 29.6 GBq (800 mCi). T",[9],[24,25,26],"lutetium Lu 177 dotatate","(Lu 177)-N-[(4,7,10-Tricarboxymethyl-1,4,7,10- tetraazacyclododec-1-yl) acetyl]-D-phenylalanyl-L-cysteinyl-L-tyrosyl-D-tryptophanyl-L-lysyl-L-threoninyl-Lcysteinyl-L-threonine-cyclic (2-7) disulfide.","177 Lu-DOTA-octreotate",{"type":20,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Gallium 68 Dotatate","Standard of care, 2 Megabecquerel (MBq)\u002Fkg (0.054 mCi\u002Fkg) up to 200 MBq (5.4 mCi)",[9],[32],"Gallium-68 DOTA-DPhe1, Tyr3-octreotate",{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"PROCEDURE","Computed Tomography (CT)","Medical Imaging",[9],[39],"CT Scan",{"type":34,"name":41,"description":36,"armGroupLabels":42,"otherNames":43},"Magnetic Resonance Imaging (MRI)",[9],null,{"type":34,"name":45,"description":36,"armGroupLabels":46,"otherNames":47},"PET\u002FCT",[9],[48],"Positron Emission Tomography (PET)",[50],{"name":51,"affiliation":52,"role":53},"Brendan C Visser, MD","Stanford Universiy","PRINCIPAL_INVESTIGATOR",[55,60],{"name":56,"role":57,"phone":58,"phoneExt":43,"email":59},"gitrialeligibility@stanford.edu gitrialeligibility@stanford.edu","CONTACT","(650) 498-7757","gpineda@stanford.edu",{"name":56,"role":57,"phone":58,"phoneExt":43,"email":61},"gitrialeligibility@stanford.edu",[63],{"facility":64,"status":65,"city":66,"state":67,"zip":68,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":76,"contacts":77},"Stanford Cancer Institute Palo Alto","RECRUITING","Stanford","California","95304","United States","US",{"type":72,"coordinates":73},"Point",[74,75],-122.16608,37.42411,{"lat":75,"lon":74},[78,79],{"name":43,"role":57,"phone":43,"phoneExt":43,"email":61},{"name":51,"role":53,"phone":43,"phoneExt":43,"email":43},{"type":81,"investigatorFullName":43,"investigatorTitle":43,"investigatorAffiliation":43,"oldNameTitle":43,"oldOrganization":43},"SPONSOR",[83],{"name":84,"class":85},"Novartis Pharmaceuticals","INDUSTRY","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",false,"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","ALL","18 Years",{"count":96,"type":97},10,"ESTIMATED","INTERVENTIONAL",[100],"PHASE1","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.",[103],"Gastroenteropancreatic Neuroendocrine Tumor","2025-09-08",{"date":106,"type":107},"2025-09-09","ACTUAL",{"date":109,"type":107},"2021-03-17",{"date":111,"type":97},"2027-09",{"name":5,"class":6},1]