Actively Recruiting
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
Led by University Hospital, Bordeaux · Updated on 2025-07-23
23
Participants Needed
4
Research Sites
78 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Bordeaux
Lead Sponsor
A
Advanced Accelerator Applications
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating a treatment approach for patients with liver metastases from neuroendocrine tumors of gastro-entero-pancreatic origin. The study compares two ways of delivering radiolabeled somatostatin analogs (SSA) used in peptide receptor radionuclide therapy (PRRT): intrahepatic arterial infusion versus the conventional intravenous method. This comparison focuses on how well the treatment targets liver tumors and the safety of an additional intrahepatic dose after standard intravenous therapy. Participants first receive four intravenous doses of the radiolabeled SSA called LUTATHERA4. Then, they undergo two PET scans using 68Ga-DOTA-peptides: one after intrahepatic injection and another after intravenous injection, to compare the uptake in liver metastases and other organs. In a subgroup of ten patients showing a significant uptake increase, a fifth dose of LUTATHERA4 is given via intra-arterial hepatic infusion, followed by SPECT/CT imaging to assess drug activity and retention. Throughout the study, participants are monitored for up to 18 months with clinical exams, MRI, and CT scans to track disease progression and safety. The primary outcomes focus on measuring standardized uptake values (SUVmax) in liver metastases using PET/CT scans. Additional assessments include uptake in healthy organs, dosimetry of the therapeutic agent, and observation of any side effects or complications related to the intrahepatic infusion approach.
CONDITIONS
Brief Title
Intra-arterial Hepatic (IAH) Infusion of Radiolabelled Somatostatin Analogs in GEP-NET Patients With Dominant Liver Metastases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically proven well differentiated neuroendocrine tumor (NET) of gastrointestinal or pancreatic origin (GEP).
- Progressive disease after treatment with cold somatostatin analog within 12 months or diagnosis with hepatic invasion > 50% without waiting for progression.
- Received 4 standard LUTATHERA® cycles.
- Liver metastatic disease is dominant or exclusive, assessable by RECIST 1.1, and not suitable for surgical resection after last cycle.
- ECOG performance status of 0 to 2.
- Adequate kidney function: creatinine clearance ≥ 50 mL/min.
- Adequate liver function: ALT/AST ≤ 2.5 times the upper limit of normal.
- No hematologic alteration after 4 LUTATHERA® cycles: hemoglobin ≥ 8 g/dL, neutrophils ≥ 1500/mm3, platelets ≥ 75,000/mm3.
- Age 18 years or older, no upper age limit.
- Contraception required for pre-menopausal females and men for at least 6 months after last LUTATHERA® injection.
- Signed informed consent.
- Affiliated to a social security system.
You will not qualify if you...
- Complete response with no lesions on imaging according to RECIST 1.1 at inclusion.
- No residual uptake on 177-Lu scintigraphy after each LUTATHERA IV treatment.
- Carcinoid heart disease with left ventricular ejection fraction below 40%.
- Dominant or threatening extrahepatic metastases affecting vital prognosis.
- Contraindications to intra-hepatic arterial infusion such as coagulation disorders, portal thrombosis, biliary tract dilatation, digestive or biliary anastomosis or fistula, or advanced cirrhosis.
- Serum albumin below 30 g/L unless prothrombin time is normal.
- Cardiovascular conditions including heart failure, myocardial infarction, stroke, uncontrolled hypertension, pulmonary embolism, unstable angina, arrhythmias, or bradycardia within the last 12 months.
- Individuals unable to give informed consent or under legal protection.
- Pregnancy or breastfeeding.
- Participation in another clinical research protocol.
- MRI scan contraindicated.
- LUTATHERA® contraindicated or toxicity during previous intravenous administrations leading to dose reduction or cancellation.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 18 days
Participants receive one treatment dose of LUTATHERA® by intra-arterial hepatic injection after completing 4 intravenous administrations of LUTATHERA®. This includes intra-hepatic injection of 68Ga-DOTA-peptides and intravenous injection of 68Ga-DOTA-peptides for PET/CT imaging to compare treatment uptake.
2 PET/CT scan visits and 1 treatment visit (in-person)
Duration - Up to 18 months
Participants are followed for up to 18 months after treatment with clinical examinations, MRI, and CT scans to monitor progression and safety.
Multiple visits for clinical examination, MRI, and CT scans as per usual care
Trial Site Locations
Total: 4 locations
1
Institut Bergonié
Bordeaux, France, 33000
Not Yet Recruiting
2
Institut de cancérologie du Gard (ICG) - CHU de Nîmes
Nîmes, France, 30029
Not Yet Recruiting
3
CHU Bordeaux - Hôpital Haut Lévêque
Pessac, France, 33604
Actively Recruiting
4
Institut universitaire du cancer de Toulouse (IUCT) Oncopole
Toulouse, France, 31100
Not Yet Recruiting
Research Team
G
Ghoufrane TLILI, Dr
M
Macary Guillaume
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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