Multi-modal Characterisation of Hepatocellular Carcinoma (HCC) Treated With Targeted Radionuclide Therapy (TRT): Prospective Interventional Multicentre National Cohort

NCT06334965 · tracked via the Priya Life Science France tracker

Sponsor

Assistance Publique - Hôpitaux de Paris

Phase

Not applicable

Started

2024-07-18

Last updated

2025-01-22

Condition(s) studied

Hepatocellular CarcinomaRadioembolization

Investigational drug(s) / intervention(s)

Simultaneous 18F-Choline PET-MRI

Simultaneous 18F-Choline PET-MRI: before first TARE administration (after work-up procedure) and one month after TARE administration

Study summary

OPERANDI project aims to address unmet clinical needs in the current management of advanced-stage HCC treated with TARE by exploring new opportunities provided by imaging-based artificial intelligence (AI) and data augmentation, simultaneous PET-MRI imaging, and novel approaches to increase patient selection and TARE efficacy (genomic profiling, radiopotentiators, and new radionuclides). The research aim to identify predictive and early markers indicative of TARE effectiveness based on a large prospective cohort of HCC patients. This cohort will be used to uncover relevant predictive signatures within the morphological, functional, and molecular imaging data using novel imaging-based AI approaches with a new patient imaging pathway including simultaneous 18F-Choline PET-MRI.

Considering this global objective, the objective of this clinical research protocol is to provide clinical, molecular and imaging data in a prospective standardized study, notably by performing systematic pretherapeutic PET-MRI, in patients with HCC treated with TARE.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Patients with HCC for whom TARE decision was made at the MDT * Patients ≥ 18 years of age * Diagnosis of HCC based on imaging (EASL guidelines) and confirmed histologically * At least one target lesion to be treated by radioembolisation, naïve to any previous treatment * Child-Pugh Class \< B8 * Eastern Cooperative Oncology Group (ECOG) ≤ 2 * Life expectancy ≥ 3 months * Available baseline imaging (multiphasic CT), performed within 6 weeks before the beginning of TARE Exclusion Criteria: * Patient with contraindication to MRI * Patient with contraindication to 18F-choline : potential hypersensitivity to the product or to any excipients * Non-adequate bone marrow, liver and renal function within 15 days prior to work-up as assessed by the following laboratory tests: * Hemoglobin ≤ 8.0 g/Dl * Platelet count \< 50,000/ mm3 * Total bilirubin \> 3 mg/dL (or \> 51 µmol/ L). * Prothrombin time ≤ 50% * Glomerular Filtration Rate (GFR) \< 35 mL/min/1.73 m2 * Infiltrating tumor more than 70% of the liver * Prior liver transplantation * Initial prescription for SIRT and concomitant systemic treatment * Patient refusal to give written and informed consent * No affiliation to a social security regimen or CMU * Patient under State Medical Aid * Known pregnancy or breastfeeding women * Patient deprived of freedom, subject under a legal protective measure * Any significant medical, psychiatric, or surgical condition that is uncontrolled and could endanger the subject's safety or limit adherence to the study's objectives and assessments

Primary outcome measure(s)

Clinical response — 12 months after the day of first administration of TARE
Clinical response defined by the PFS as the time measured from the day of first administration of TARE to first progression or death at 12 months, whichever occurs first

Trial sites (5)

Facility	City	Region	Status
Service de Médecine Nucléaire, Hôpital Beaujon	Clichy	France	Recruiting
Beaujon hospital	Clichy	France	Recruiting
CHU Nantes	Nantes	France	Active Not Recruiting
Service de Médecine Nucléaire, CHU de Nantes	Nantes	France	Recruiting
Service de medecine nucleaire, Hôpital Bichat	Paris	France	Active Not Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06334965 on ClinicalTrials.gov ↗ ← All trials in France