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.
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
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
Single group
Simultaneous 18F-Choline PET-MRI
Other interventionbefore first TARE administration (after work-up procedure) and one month after TARE administration
Clinical response
Clinical response defined by the PFS as the time measured from the day of first administration of TARE to first progression or death at 12 months, whichever occurs first
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