RecruitingNot ApplicableNCT06334965

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

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

180 participants

Start Date

Jul 18, 2024

Study Type

INTERVENTIONAL

Conditions

Hepatocellular Carcinoma Radioembolization

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is using multiple imaging and biological tests to better understand liver cancer (HCC) before and after a treatment called radioembolization (TARE), where tiny radioactive beads are delivered directly into the liver tumor through a blood vessel. The goal is to find better ways to predict which patients will respond to this treatment. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with liver cancer (HCC) confirmed by both imaging and biopsy - Your multidisciplinary team has approved radioembolization as your treatment - Your liver function is adequate (Child-Pugh class below B8) - You have not received prior treatment for your liver cancer - You have a good functional status and life expectancy of at least 3 months **You may NOT be eligible if...** - You have a contraindication to MRI (such as a pacemaker) - You have poor bone marrow, liver, or kidney function - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERSimultaneous 18F-Choline PET-MRI

before first TARE administration (after work-up procedure) and one month after TARE administration

Locations(5)

Service de Médecine Nucléaire, Hôpital Beaujon

Clichy, France

Beaujon hospital

Clichy, France

CHU Nantes

Nantes, France

Service de Médecine Nucléaire, CHU de Nantes

Nantes, France

Service de medecine nucleaire, Hôpital Bichat

Paris, France

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NCT06334965

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