Intra-arterial Hepatic (IAH) Infusion of Radiolabelled Somatostatin Analogs in GEP-NET Patients With Dominant Liver Metastases

Recruiting now · Phase 2

Conditions studied: Neuroendocrine Tumor, Liver Metastases, Neuroendocrine Gastroenteropancreatic Tumour

In brief

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).

Key facts

Study ID: NCT04837885
Run by: University Hospital, Bordeaux
People needed: 23
Starts: 2021-09-24
Expected to finish: 2027-03-24
Last updated by the study team: 2025-07-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

CHU Bordeaux - Hôpital Haut Lévêque — Pessac, France (enrolling)
Institut Bergonié — Bordeaux, France
Institut de cancérologie du Gard (ICG) - CHU de Nîmes — Nîmes, France
Institut universitaire du cancer de Toulouse (IUCT) Oncopole — Toulouse, France

Full record on ClinicalTrials.gov

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