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

NCT04837885 | Recruiting Phase 2 DMC

• 1 other identifier: CHUBX 2017/47
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 4

Brief 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).

Conditions

Neuroendocrine Tumor; Liver Metastases; Neuroendocrine Gastroenteropancreatic Tumour

Keywords

Neuroendocrine tumour; Neuroendocrine gastroenteropancreatic (GEP) tumour; Liver Metastases; 68Ga- DOTA-peptides PET CT; 177Lutetium-Octreotate; Peptide Receptor Radionuclide Therapy

Outcome Measures

Primary Outcomes (2)

• Standardized uptake value (SUVmax) on liver metastases

  Standardized uptake value (SUVmax) on liver metastase obtained on PET/CT imaging after injection of 68Ga-DOTA-peptides

  Day 0 (First PET/CT)

• Standardized uptake value (SUVmax) on liver metastases

  Standardized uptake value (SUVmax) on liver metastase obtained on PET/CT imaging after injection of 68Ga-DOTA-peptides

  Day 3 (second PET/CT)

Secondary Outcomes (11)

• Standardized uptake value (SUVmax) on healthy liver

  Day 0 (First PET/CT)

• Standardized uptake value (SUVmax) on healthy liver

  Day 3 (second PET/CT)

• Standardized uptake value (SUVmax) on kidneys

  Day 0 (First PET/CT)

• Standardized uptake value (SUVmax) on kidneys

  Day 3 (second PET/CT)

• Standardized uptake value (SUVmax) on bone marrow

  Day 0 (First PET/CT)

Study Arms (1)

68Ga-DOTA-peptides PET/CT

EXPERIMENTAL

68Ga-DOTA-peptides injections for targeted liver metastases in Positron emission tomography-computed tomography (PET/CT) One treatment dose of LUTATHERA® by intra-arterial hepatic injection (IAH) after conventional treatment by 4 intravenous administrations

Procedure: Positron emission tomography computed tomography (PET/CT) with Intra-hepatic (IAH) injection; Procedure: Positron emission tomography computed tomography (PET/CT) with Intravenous (IV) injection; Drug: LUTATHERA® by intra-arterial hepatic (IAH) injection; Procedure: Scan

Interventions

Positron emission tomography computed tomography (PET/CT) with Intra-hepatic (IAH) injection PROCEDURE

Intra-hepatic injection of 68Ga-DOTA-peptides for targeted liver metastases in Positron emission tomography-computed tomography (PET/CT)

68Ga-DOTA-peptides PET/CT

Positron emission tomography computed tomography (PET/CT) with Intravenous (IV) injection PROCEDURE

intravenous injection of 68Ga-DOTA-peptides for targeted liver metastases in Positron emission tomography-computed tomography (PET/CT)

68Ga-DOTA-peptides PET/CT

LUTATHERA® by intra-arterial hepatic (IAH) injection DRUG

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

68Ga-DOTA-peptides PET/CT

Scan PROCEDURE

Scans after completion of LUTATHERA® treatment injection

68Ga-DOTA-peptides PET/CT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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:

• 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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead
• Advanced Accelerator Applications: collaborator

Study Sites (4)

Institut Bergonié

Bordeaux, 33000, France

NOT YET RECRUITING

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

Nîmes, 30029, France

NOT YET RECRUITING

CHU Bordeaux - Hôpital Haut Lévêque

Pessac, 33604, France

RECRUITING

Institut universitaire du cancer de Toulouse (IUCT) Oncopole

Toulouse, 31100, France

NOT YET RECRUITING

MeSH Terms

Conditions

Neuroendocrine Tumors; Neoplasms

Interventions

Injections

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Ghoufrane TLILI

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ghoufrane TLILI, Dr

CONTACT

05 57 65 64 08; ghoufrane.tlili@chu-bordeaux.fr

Macary Guillaume

CONTACT

05 57 62 32 52; guillaume.macary@chu-bordeaux.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2021
• First Posted: April 8, 2021
• Study Start: September 24, 2021
• Primary Completion: September 24, 2025
• Study Completion (Estimated): March 24, 2027
• Last Updated: July 23, 2025

Record last verified: 2025-07

Locations

FR (4)