Actively Recruiting
Multi-modal Characterisation of Hepatocellular Carcinoma (HCC) Treated With Targeted Radionuclide Therapy (TRT): Prospective Interventional Multicentre National Cohort
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
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.
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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
F
Françoise KRAEBER - BODERE
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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