Actively Recruiting
Intra-arterial Hepatic (IAH) Infusion of Radiolabelled Somatostatin Analogs in GEP-NET Patients With Dominant Liver Metastases
Led by University Hospital, Bordeaux · Updated on 2025-07-23
23
Participants Needed
4
Research Sites
286 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
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).
CONDITIONS
Official 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 hepatic invasion > 50% without waiting for progression.
- Completed 4 standard LUTATHERA® treatment cycles.
- Liver metastatic disease dominant or exclusive, assessable by RECIST 1.1, and not suitable for surgical removal after last cycle.
- ECOG performance status between 0 and 2.
- Adequate kidney and liver function: creatinine clearance ≥ 50 mL/min, ALT/AST ≤ 2.5 times upper normal limit.
- No blood abnormalities after 4 LUTATHERA® cycles: hemoglobin ≥ 8 g/dL, neutrophils ≥ 1500/mm3, platelets ≥ 75,000/mm3.
- Age 18 years or older, no upper age limit.
- Use of contraception required for pre-menopausal women and men for at least 6 months after last LUTATHERA® dose.
- Signed informed consent.
- Affiliated to a social security system.
You will not qualify if you...
- Complete response with no lesions on CT scan and MRI.
- No residual uptake on 177-Lu scintigraphy after LUTATHERA® intravenous treatment.
- Carcinoid heart disease with left ventricular ejection fraction less than 40%.
- Dominant or threatening extrahepatic metastases affecting vital prognosis.
- Contraindications to intra-hepatic arterial infusion such as coagulation disorders, portal thrombosis, biliary tract issues, or cirrhosis (Child Pugh B8 or C and above).
- Serum albumin below 30 g/L unless normal prothrombin time.
- Recent serious heart conditions or uncontrolled hypertension.
- Individuals unable to give informed consent or under legal protection.
- Pregnancy or breastfeeding.
- Participation in another clinical research protocol.
- MRI scan contraindications.
- LUTATHERA® contraindicated or toxicity causing dose reduction or cancellation during intravenous treatment.
AI-Screening
AI-Powered Screening
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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
CONTACT
M
Macary Guillaume
CONTACT
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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