RecruitingPhase 2NCT04837885

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

"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"


Sponsor

University Hospital, Bordeaux

Enrollment

23 participants

Start Date

Sep 24, 2021

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether delivering radioactive therapy directly into the liver's blood supply — rather than through a vein — can improve outcomes for patients with a type of slow-growing gut or pancreatic tumor (called a neuroendocrine tumor) that has mainly spread to the liver. **You may be eligible if:** - You have a confirmed neuroendocrine tumor originating from the gut or pancreas - Your disease has progressed despite standard treatment with a cold somatostatin analog - You have already completed 4 standard cycles of LUTATHERA (a radioactive therapy) - Most or all of your cancer is in the liver and cannot be surgically removed - You have acceptable blood counts, kidney, and liver function - You are 18 or older **You may NOT be eligible if:** - Your tumor showed a complete response (disappeared entirely) after LUTATHERA - You have significant cancer outside the liver that threatens your life - You have heart disease affecting your heart's pumping ability - You have liver cirrhosis or other conditions preventing safe delivery of therapy into the liver's arteries - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREPositron 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)

PROCEDUREPositron 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)

DRUGLUTATHERA® 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

PROCEDUREScan

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

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NCT04837885


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