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

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).

NCT Number	NCT04837885
Lead Sponsor	University Hospital, Bordeaux Collaborators: Advanced Accelerator Applications
Conditions	Neuroendocrine Tumor, Liver Metastases, Neuroendocrine Gastroenteropancreatic Tumour
Enrollment	23 participants
Start Date	2021-09-24
Primary Completion	2025-09-24 (estimated)
Study Completion	2027-03-24 (estimated)
Updated on ClinicalTrials.gov	2025-07-23