[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100426813":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":37,"centralContacts":41,"locations":51,"responsibleParty":110,"collaborators":112,"id":116,"slug":117,"hasResults":118,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":122,"eligibilityCriteria":123,"healthyVolunteers":118,"sex":124,"minAge":125,"maxAge":23,"enrollmentInfo":126,"targetDuration":23,"studyType":129,"phases":130,"briefSummary":132,"conditions":133,"keywords":137,"overallStatus":84,"whyStopped":23,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":152},{"fullName":5,"class":6},"University Hospital, Bordeaux","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"68Ga-DOTA-peptides PET\u002FCT","EXPERIMENTAL","68Ga-DOTA-peptides injections for targeted liver metastases in Positron emission tomography-computed tomography (PET\u002FCT)\n\nOne treatment dose of LUTATHERA® by intra-arterial hepatic injection (IAH) after conventional treatment by 4 intravenous administrations",[13,14,15,16],"Procedure: Positron emission tomography computed tomography (PET\u002FCT) with Intra-hepatic (IAH) injection","Procedure: Positron emission tomography computed tomography (PET\u002FCT) with Intravenous (IV) injection","Drug: LUTATHERA® by intra-arterial hepatic (IAH) injection","Procedure: Scan",[18,24,28,33],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"PROCEDURE","Positron emission tomography computed tomography (PET\u002FCT) with Intra-hepatic (IAH) injection","Intra-hepatic injection of 68Ga-DOTA-peptides for targeted liver metastases in Positron emission tomography-computed tomography (PET\u002FCT)",[9],null,{"type":19,"name":25,"description":26,"armGroupLabels":27,"otherNames":23},"Positron emission tomography computed tomography (PET\u002FCT) with Intravenous (IV) injection","intravenous injection of 68Ga-DOTA-peptides for targeted liver metastases in Positron emission tomography-computed tomography (PET\u002FCT)",[9],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":23},"DRUG","LUTATHERA® by intra-arterial hepatic (IAH) injection","One treatment dose of LUTATHERA® by IAH injection. The LUTATHERA® by intra-arterial hepatic injection treatment is realised after the conventional treatment by 4 intravenous administrations",[9],{"type":19,"name":34,"description":35,"armGroupLabels":36,"otherNames":23},"Scan","Scans after completion of LUTATHERA® treatment injection",[9],[38],{"name":39,"affiliation":5,"role":40},"Ghoufrane TLILI","PRINCIPAL_INVESTIGATOR",[42,47],{"name":43,"role":44,"phone":45,"phoneExt":23,"email":46},"Ghoufrane TLILI, Dr","CONTACT","05 57 65 64 08","ghoufrane.tlili@chu-bordeaux.fr",{"name":48,"role":44,"phone":49,"phoneExt":23,"email":50},"Macary Guillaume","05 57 62 32 52","guillaume.macary@chu-bordeaux.fr",[52,69,82,97],{"facility":53,"status":54,"city":55,"state":23,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"Institut Bergonié","NOT_YET_RECRUITING","Bordeaux","33000","France","FR",{"type":60,"coordinates":61},"Point",[62,63],-0.58046,44.84124,{"lat":63,"lon":62},[66],{"name":67,"role":44,"phone":23,"phoneExt":23,"email":68},"Yann GODBERT, Dr","y.godbert@bordeaux.unicancer.fr",{"facility":70,"status":54,"city":71,"state":23,"zip":72,"country":57,"countryCode":58,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"Institut de cancérologie du Gard (ICG) - CHU de Nîmes","Nîmes","30029",{"type":60,"coordinates":74},[75,76],4.35788,43.83665,{"lat":76,"lon":75},[79],{"name":80,"role":44,"phone":23,"phoneExt":23,"email":81},"Vincent BOUDOUSQ, Dr","vincent.boudousq@chu-nimes.fr",{"facility":83,"status":84,"city":85,"state":23,"zip":86,"country":57,"countryCode":58,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"CHU Bordeaux - Hôpital Haut Lévêque","RECRUITING","Pessac","33604",{"type":60,"coordinates":88},[89,90],-0.6324,44.80565,{"lat":90,"lon":89},[93,94,96],{"name":43,"role":44,"phone":45,"phoneExt":23,"email":46},{"name":95,"role":44,"phone":49,"phoneExt":23,"email":50},"Guillaume Macary",{"name":39,"role":40,"phone":23,"phoneExt":23,"email":23},{"facility":98,"status":54,"city":99,"state":23,"zip":100,"country":57,"countryCode":58,"cosmosGeoPoint":101,"geoPoint":105,"contacts":106},"Institut universitaire du cancer de Toulouse (IUCT) Oncopole","Toulouse","31100",{"type":60,"coordinates":102},[103,104],1.44367,43.60426,{"lat":104,"lon":103},[107],{"name":108,"role":44,"phone":23,"phoneExt":23,"email":109},"Frederic Courbon, Pr","courbon.frederic@iuct-oncopole.fr",{"type":111,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR",[113],{"name":114,"class":115},"Advanced Accelerator Applications","INDUSTRY","100426813","phase-2-intra-arterial-hepatic-iah-infusion-of-radiolabelled-somatostatin-analogs-in-gep-net-patients-with-dominant-liver-metastases-100426813",false,"NCT04837885","Intra-arterial Hepatic (IAH) Infusion of Radiolabelled Somatostatin Analogs in GEP-NET Patients With Dominant Liver Metastases","\"Imaging With 68Ga-DOTA-peptides and Peptide Receptor Radionuclide Therapy With 177Lu-DOTA-peptides of Gastroenteropancreatic Neuroendocrine Tumors: Interest of Intra-arterial Hepatic Infusion in Patients With Dominant Liver Metastases\"","LUTARTERIAL","Inclusion Criteria:\n\n* Histologically proven well differentiated neuroendocrine tumor (NET) of gastrointestinal or pancreatic origin (GEP).\n* Patients are progressive after treatment with cold somatostatin analog (within 12 months according to RECIST), or as soon as the diagnosis is made in case of hepatic invasion \\> 50% without waiting for tumour progression\n* Patient has received 4 standard of care LUTATHERA® cycles\n* Liver Metastatic disease dominant or exclusive and assessable by RECIST 1.1, and not amenable to surgical resection after the last cycle\n* ECOG performance status 0-2\n* Adequate kidney and liver function: creatinine clearance ≥ 50 mL\u002Fmin, ALT\u002FAST ≤ 2,5x the upper limit of normal\n* With no evidence of hematologic alteration after 4 LUTATHERA® cycles: hemoglobin ≥ 8 g\u002FdL, neutrophils ≥ 1500\u002F mm3, platelets ≥ 75.000\u002Fmm3\n* Age ≥ 18 years, no superior limit\n* Contraception required in pre-menopausal female (Intrauterine device, Progestin Pills, Combined Oral Contraceptives, Monthly Injectables, Progestin Injectables, Combined Patch, Combined Vaginal Ring, Female Sterilization, Vasectomy, Implants) and men for at least 6 months after the last LUTATHERA ® injection.\n* Patient´s signed written informed consent\n* Patient affiliated to a social security system\n\nExclusion Criteria:\n\n* Patients with complete response defined by the absence of lesion according to RECIST 1.1 realized during morphological imaging at inclusion (chest-abdomen-pelvis CT scan and hepatic MRI)\n* No residual uptake according to standard 177-Lu scintigraphy performed in the clinical routine 24 hours after each LUTATHERA IV treatment\n* Carcinoid heart disease (LVEF \\\u003C 40%)\n* Dominant or threatening extrahepatic metastases or that may affect vital prognosis\n* Contraindications to intra-hepatic arterial infusion (coagulation disorders, portal thrombosis, intra-hepatic biliary tract dilatation, digestive or biliary anastomosis or fistula, cirrhosis (Child Pugh B8 or C…)\n* Serum albumin \\\u003C30 g\u002FL unless prothrombin time is within the normal range.\n* Heart failure, myocardial infarction, stroke, uncontrolled arterial hypertension under optimal treatment (≥ 160\u002F95 mmHg), pulmonary embolism or revascularization procedure, unstable angina pectoris, uncontrolled cardiac arrhythmia, and clinically significant bradycardia during the last 12 months.\n* Individuals under legal protection or unable of giving their informed consent\n* Pregnancy or breast feeding\n* Currently participating to another clinical research protocol\n* Individuals under legal protection or unable of giving their informed consent\n* MRI scan contraindicated\n* LUTATHERA® contraindicated or toxicity during one of the IV administrations leading to a reduction or cancellation of the following dose","ALL","18 Years",{"count":127,"type":128},23,"ESTIMATED","INTERVENTIONAL",[131],"PHASE2","The management of liver metastases in neuroendocrine neoplasms is challenging. Peptide receptor radionuclide therapy with radiolabeled somatostatin analogs (SSA) is one of the most promising therapeutic options. As liver is the most frequent site of metastatic disease, our project proposes to compare administration of radiolabeled SSA by arterial intrahepatic infusion (experimental approach) vs intravenous administration (conventional). Evaluation will be made by (i) comparing 68Ga-DOTA-peptides uptake after intra-hepatic versus intravenous route (imaging), (ii) by evaluating the safety of an additional intra-hepatic administration of therapeutic radiolabeled SSA (therapy).",[134,135,136],"Neuroendocrine Tumor","Liver Metastases","Neuroendocrine Gastroenteropancreatic Tumour",[138,139,135,140,141,142],"Neuroendocrine tumour","Neuroendocrine gastroenteropancreatic (GEP) tumour","68Ga- DOTA-peptides PET CT","177Lutetium-Octreotate","Peptide Receptor Radionuclide Therapy","2025-07-18",{"date":145,"type":146},"2025-07-23","ACTUAL",{"date":148,"type":146},"2021-09-24",{"date":150,"type":128},"2027-03-24",{"name":5,"class":6},4]