Actively Recruiting
Study of Targeted Radionuclide Therapy for Hepatocellular Carcinoma Using Advanced PET-MRI Imaging Prospective Multicentre Research on Predictive Markers and Treatment Response
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-01-22
180
Participants Needed
5
Research Sites
267 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research focuses on hepatocellular carcinoma (HCC), a common and deadly liver cancer with increasing incidence worldwide. The study aims to improve the management of advanced-stage HCC treated with targeted radionuclide therapy (TARE) by using new imaging techniques, artificial intelligence (AI), and data analysis methods to better predict treatment effectiveness and improve patient selection. It addresses the current lack of reliable imaging markers to identify early responders to TARE, which is important for personalizing treatment and improving outcomes. Participants will undergo simultaneous 18F-Choline PET-MRI scans before their first TARE treatment and again one month after TARE administration. This PET-MRI combines detailed magnetic resonance imaging with metabolic PET imaging to provide comprehensive morphological, functional, and molecular data. The study evaluates this advanced imaging along with clinical and molecular data to find predictive markers of TARE response using AI techniques. The TARE treatment involves injecting radioactive microspheres into the liver artery to target tumors. During the study, patients will be monitored through scheduled imaging and clinical assessments to track their response to TARE over 12 months. Researchers will analyze these data to identify early signs of treatment effectiveness. Safety and patient condition will be regularly checked, including laboratory tests and evaluation of liver function. The study collects detailed information to support better personalized care for patients with HCC treated with TARE.
CONDITIONS
Official Title
Multi-modal Characterisation of Hepatocellular Carcinoma (HCC) Treated With Targeted Radionuclide Therapy (TRT): Prospective Interventional Multicentre National Cohort
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with HCC for whom TARE decision was made at the MDT
- Patients 18 years of age or older
- Diagnosis of HCC based on imaging (EASL guidelines) and confirmed histologically
- At least one target lesion to be treated by radioembolisation, naive to any previous treatment
- Child-Pugh Class less than B8
- Eastern Cooperative Oncology Group (ECOG) performance status 2 or less
- Life expectancy of 3 months or more
- Available baseline multiphasic CT imaging performed within 6 weeks before TARE start
You will not qualify if you...
- Contraindication to MRI
- Contraindication to 18F-choline, including potential hypersensitivity to the product or excipients
- Inadequate bone marrow, liver, or renal function within 15 days prior to work-up as defined by:
- Hemoglobin 8.0 g/dL or less
- Platelet count less than 50,000/mm3
- Total bilirubin greater than 3 mg/dL (or 51 µmol/L)
- Prothrombin time 50% or less
- Glomerular filtration rate less than 35 mL/min/1.73 m2
- Infiltrating tumor occupying more than 70% of the liver
- Prior liver transplantation
- Initial prescription for selective internal radiation therapy (SIRT) combined with systemic treatment
- Refusal to provide written informed consent
- No social security affiliation or CMU
- Under State Medical Aid
- Known pregnancy or breastfeeding
- Subject under legal protective measures or deprived of freedom
- Any uncontrolled significant medical, psychiatric, or surgical condition that may endanger safety or limit study adherence
AI-Screening
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Trial Site Locations
Total: 5 locations
1
Service de Médecine Nucléaire, Hôpital Beaujon
Clichy, France, 92110
Actively Recruiting
2
Beaujon hospital
Clichy, France
Actively Recruiting
3
CHU Nantes
Nantes, France
Active, Not Recruiting
4
Service de Médecine Nucléaire, CHU de Nantes
Nantes, France
Actively Recruiting
5
Service de medecine nucleaire, Hôpital Bichat
Paris, France, 75018
Active, Not Recruiting
Research Team
V
Valérie VILGRAIN
F
Françoise KRAEBER - BODERE
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
Frequently Asked Questions
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