Multi-modal Characterisation of Hepatocellular Carcinoma (HCC) Treated With Targeted Radio
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 e
| Condition(s) | Hepatocellular Carcinoma, Radioembolization |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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 th |
| Who can participate | Inclusion Criteria: * 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 * Child-Pugh Class \< B8 * Eastern Cooperative Oncology Group (ECOG) ≤ 2 * Life expectancy ≥ 3 months * Available baseline imaging (multiphasic CT), performed within 6 weeks before the beginning of TARE Exclusion Criteria: * Patient with contraindication to MRI * Patient with contraindication to 18F-choline : potential hypersensitivity to the product or to any excipients * Non-adequate bone marrow, liver and renal function within 15 days prior to work-up as assessed by the following laboratory tests: * |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Assistance Publique - Hôpitaux de Paris |
| Locations | Clichy, France; Clichy, France; Nantes, France; Nantes, France; Paris, France |
| Start date | 2024-07-18 |
| NCT ID | NCT06334965 |
| Official listing | https://clinicaltrials.gov/study/NCT06334965 |