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RECRUITING
NCT04837885
PHASE2

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

Sponsor: University Hospital, Bordeaux

View on ClinicalTrials.gov

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 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).

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"

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

23

Start Date

2021-09-24

Completion Date

2027-03-24

Last Updated

2025-07-23

Healthy Volunteers

No

Interventions

PROCEDURE

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)

PROCEDURE

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)

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

PROCEDURE

Scan

Scans after completion of LUTATHERA® treatment injection

Locations (4)

Institut Bergonié

Bordeaux, France

Institut de cancérologie du Gard (ICG) - CHU de Nîmes

Nîmes, France

CHU Bordeaux - Hôpital Haut Lévêque

Pessac, France

Institut universitaire du cancer de Toulouse (IUCT) Oncopole

Toulouse, France