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Clinical Trial NCT04837885 (LUTARTERIAL) for Neuroendocrine Tumor, Liver Metastases, Neuroendocrine Gastroenteropancreatic Tumour is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Intra-arterial Hepatic (IAH) Infusion of Radiolabelled Somatostatin Analogs in GEP-NET Patients With Dominant Liver Metastases (LUTARTERIAL) Phase 2 23
Clinical Trial NCT04837885 (LUTARTERIAL) is designed to study Treatment for Neuroendocrine Tumor, Liver Metastases, Neuroendocrine Gastroenteropancreatic Tumour. It is a Phase 2 interventional study that is recruiting, having started on 24 September 2021, with plans to enroll 23 participants. Led by University Hospital, Bordeaux, it is expected to complete by 24 March 2027. The latest data from ClinicalTrials.gov was last updated on 23 July 2025.
Brief Summary
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 administra...Show More
Detailed Description
Liver metastases of neuroendocrine tumors of gastro-entero-pancreatic origin are one of the most limiting factors of patient survival. Peptide receptor radionuclide therapy with radiolabeled somatostatin analogs (SSA) such as LUTATHERA® represents now a major therapeutic option. As far as these metastases are mainly perfused by the hepatic artery, it could be relevant to deliver the treatment by intra-hepatic route, ...Show More
Official Title
"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"
Conditions
Neuroendocrine TumorLiver MetastasesNeuroendocrine Gastroenteropancreatic TumourOther Study IDs
- LUTARTERIAL
- CHUBX 2017/47
NCT ID Number
Start Date (Actual)
2021-09-24
Last Update Posted
2025-07-23
Completion Date (Estimated)
2027-03-24
Enrollment (Estimated)
23
Study Type
Interventional
PHASE
Phase 2
Status
Recruiting
Keywords
Neuroendocrine tumour
Neuroendocrine gastroenteropancreatic (GEP) tumour
Liver Metastases
68Ga- DOTA-peptides PET CT
177Lutetium-Octreotate
Peptide Receptor Radionuclide Therapy
Neuroendocrine gastroenteropancreatic (GEP) tumour
Liver Metastases
68Ga- DOTA-peptides PET CT
177Lutetium-Octreotate
Peptide Receptor Radionuclide Therapy
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Experimental68Ga-DOTA-peptides PET/CT 68Ga-DOTA-peptides injections for targeted liver metastases in Positron emission tomography-computed tomography (PET/CT)
One treatment dose of LUTATHERA® by intra-arterial hepatic injection (IAH) after conventional treatment by 4 intravenous administrations | Positron emission tomography computed tomography (PET/CT) with Intra-hepatic (IAH) injection Intra-hepatic injection of 68Ga-DOTA-peptides for targeted liver metastases in Positron emission tomography-computed tomography (PET/CT) Positron emission tomography computed tomography (PET/CT) with Intravenous (IV) injection intravenous injection of 68Ga-DOTA-peptides for targeted liver metastases in Positron emission tomography-computed tomography (PET/CT) 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 Scan Scans after completion of LUTATHERA® treatment injection |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Standardized uptake value (SUVmax) on liver metastases | Standardized uptake value (SUVmax) on liver metastase obtained on PET/CT imaging after injection of 68Ga-DOTA-peptides | Day 0 (First PET/CT) |
Standardized uptake value (SUVmax) on liver metastases | Standardized uptake value (SUVmax) on liver metastase obtained on PET/CT imaging after injection of 68Ga-DOTA-peptides | Day 3 (second PET/CT) |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Standardized uptake value (SUVmax) on healthy liver | Standardized uptake value (SUVmax) on healthy liver obtained on PET/CT imaging after injection of 68Ga-DOTA-peptides | Day 0 (First PET/CT) |
Standardized uptake value (SUVmax) on healthy liver | Standardized uptake value (SUVmax) on healthy liver obtained on PET/CT imaging after injection of 68Ga-DOTA-peptides | Day 3 (second PET/CT) |
Standardized uptake value (SUVmax) on kidneys | Standardized uptake value (SUVmax) on kidneys obtained on PET/CT imaging after injection of 68Ga-DOTA-peptides | Day 0 (First PET/CT) |
Standardized uptake value (SUVmax) on kidneys | Standardized uptake value (SUVmax) on kidneys obtained on PET/CT imaging after injection of 68Ga-DOTA-peptides | Day 3 (second PET/CT) |
Standardized uptake value (SUVmax) on bone marrow | Standardized uptake value (SUVmax) on bone marrow obtained on PET/CT imaging after injection of 68Ga-DOTA-peptides | Day 0 (First PET/CT) |
Standardized uptake value (SUVmax) on bone marrow | Standardized uptake value (SUVmax) on bone marrow obtained on PET/CT imaging after injection of 68Ga-DOTA-peptides | Day 3 (second PET/CT) |
Standardized uptake value (SUVmax) on spleen | Standardized uptake value (SUVmax) on spleen obtained on PET/CT imaging after injection of 68Ga-DOTA-peptides | Day 0 (First PET/CT) |
Standardized uptake value (SUVmax) on spleen | Standardized uptake value (SUVmax) on spleen obtained on PET/CT imaging after injection of 68Ga-DOTA-peptides | Day 3 (second PET/CT) |
Standardized uptake value (SUVmax) on associated extra-hepatic metastases | Standardized uptake value (SUVmax) on associated extra-hepatic metastases obtained on PET/CT imaging after injection of 68Ga-DOTA-peptides | Day 0 (First PET/CT) |
Standardized uptake value (SUVmax) on associated extra-hepatic metastases | Standardized uptake value (SUVmax) on associated extra-hepatic metastases obtained on PET/CT imaging after injection of 68Ga-DOTA-peptides | Day 3 (second PET/CT) |
177Lu-DOTA-peptide dosimetry | Absorbed dose in different tissue of the 5 hepatic targets, possible extra-hepatic lesions and healthy organs (healthy liver, kidney, bone marrow, spleen) | Day 18 |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- Histologically proven well differentiated neuroendocrine tumor (NET) of gastrointestinal or pancreatic origin (GEP).
- 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
- Patient has received 4 standard of care LUTATHERA® cycles
- Liver Metastatic disease dominant or exclusive and assessable by RECIST 1.1, and not amenable to surgical resection after the last cycle
- ECOG performance status 0-2
- Adequate kidney and liver function: creatinine clearance ≥ 50 mL/min, ALT/AST ≤ 2,5x the upper limit of normal
- With no evidence of hematologic alteration after 4 LUTATHERA® cycles: hemoglobin ≥ 8 g/dL, neutrophils ≥ 1500/ mm3, platelets ≥ 75.000/mm3
- Age ≥ 18 years, no superior limit
- 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.
- Patient´s signed written informed consent
- Patient affiliated to a social security system
- 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)
- No residual uptake according to standard 177-Lu scintigraphy performed in the clinical routine 24 hours after each LUTATHERA IV treatment
- Carcinoid heart disease (LVEF < 40%)
- Dominant or threatening extrahepatic metastases or that may affect vital prognosis
- 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…)
- Serum albumin <30 g/L unless prothrombin time is within the normal range.
- Heart failure, myocardial infarction, stroke, uncontrolled arterial hypertension under optimal treatment (≥ 160/95 mmHg), pulmonary embolism or revascularization procedure, unstable angina pectoris, uncontrolled cardiac arrhythmia, and clinically significant bradycardia during the last 12 months.
- Individuals under legal protection or unable of giving their informed consent
- Pregnancy or breast feeding
- Currently participating to another clinical research protocol
- Individuals under legal protection or unable of giving their informed consent
- MRI scan contraindicated
- LUTATHERA® contraindicated or toxicity during one of the IV administrations leading to a reduction or cancellation of the following dose
University Hospital, BordeauxAdvanced Accelerator ApplicationsStudy Central Contact
Contact: Ghoufrane TLILI, Dr, 05 57 65 64 08, [email protected]
Contact: Macary Guillaume, 05 57 62 32 52, [email protected]
4 Study Locations in 1 Countries
Institut Bergonié, Bordeaux, 33000, France
Yann GODBERT, Dr, Contact, [email protected]
Not yet recruiting
Institut de cancérologie du Gard (ICG) - CHU de Nîmes, Nîmes, 30029, France
Vincent BOUDOUSQ, Dr, Contact, [email protected]
Not yet recruiting
CHU Bordeaux - Hôpital Haut Lévêque, Pessac, 33604, France
Ghoufrane TLILI, Dr, Contact, 05 57 65 64 08, [email protected]
Guillaume Macary, Contact, 05 57 62 32 52, [email protected]
Ghoufrane TLILI, Principal Investigator
Recruiting
Institut universitaire du cancer de Toulouse (IUCT) Oncopole, Toulouse, 31100, France
Frederic Courbon, Pr, Contact, [email protected]
Not yet recruiting