Characterizing liver cancer treatment with advanced imaging techniques
Multi-modal Characterisation of Hepatocellular Carcinoma (HCC) Treated With Targeted Radionuclide Therapy (TRT): Prospective Interventional Multicentre National Cohort
This study is testing new imaging techniques to see if they can help doctors better treat patients with advanced liver cancer using targeted radionuclide therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Drugs / interventions | radiation |
| Locations | 5 sites (Clichy and 4 other locations) |
| Trial ID | NCT06334965 on ClinicalTrials.gov |
What this trial studies
This project aims to improve the management of advanced-stage hepatocellular carcinoma (HCC) treated with targeted radionuclide therapy (TARE) by utilizing innovative imaging-based artificial intelligence and simultaneous PET-MRI imaging. The study will create a large prospective cohort of HCC patients to identify predictive markers for TARE effectiveness, focusing on genomic profiling and novel radionuclides. By standardizing clinical, molecular, and imaging data collection, the research seeks to enhance patient selection and treatment efficacy for those undergoing TARE.
Who should consider this trial
Good fit: Ideal candidates include adults with a confirmed diagnosis of HCC who are eligible for TARE and have not received prior treatment.
Not a fit: Patients with contraindications to MRI or 18F-choline, or those with inadequate organ function, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective treatment strategies for patients with hepatocellular carcinoma.
How similar studies have performed: While TARE has shown promise in treating HCC, the integration of advanced imaging techniques and AI for patient stratification is a novel approach that has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Clichy and 4 other locations
- 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)
Study contacts
- Principal investigator: Catherine ANSQUER, Dr — Nantes University Hospital
- Study coordinator: Valérie VILGRAIN
- Email: valerie.vilgrain@aphp.fr
- Phone: 00-33-1-40-87-53-58
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.