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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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 criteria

Qualifiers

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

Disqualifiers

Patient with contraindication to MRI

Patient with contraindication to 18F-choline : potential hypersensitivity to the product or to any excipients

Hemoglobin ≤ 8.0 g/Dl

Platelet count < 50,000/ mm3

Trial design

Treatments tested in this trial

  • Simultaneous 18F-Choline PET-MRI

Treatment groups

180 Participants
are divided into 1 treatment group