Multi-modal Characterisation of Hepatocellular Carcinoma (HCC) Treated With Targeted Radionuclide Therapy (TRT): Prospective Interventional Multicentre National Cohort
Trial ID: NCT06334965
Status: RECRUITING
Study type: INTERVENTIONAL
Phase: NA
Start date: 2024-07-18
Completion date: 2029-09
Sponsor: Assistance Publique - Hôpitaux de Paris
Conditions: Hepatocellular Carcinoma; Radioembolization
Interventions: Simultaneous 18F-Choline PET-MRI
Locations: Service de Médecine Nucléaire, Hôpital Beaujon; Beaujon hospital; CHU Nantes; Service de Médecine Nucléaire, CHU de Nantes; Service de medecine nucleaire, Hôpital Bichat
Countries: France; France; France; France; France
Enrollment: 180
Age range: 18 Years - None
Sex: ALL

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 criteria:
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:

  * Hemoglobin ≤ 8.0 g/Dl
  * Platelet count \< 50,000/ mm3
  * Total bilirubin \> 3 mg/dL (or \> 51 µmol/ L).
  * Prothrombin time ≤ 50%
  * Glomerular Filtration Rate (GFR) \< 35 mL/min/1.73 m2
* Infiltrating tumor more than 70% of the liver
* Prior liver transplantation
* Initial prescription for SIRT and concomitant systemic treatment
* Patient refusal to give written and informed consent
* No affiliation to a social security regimen or CMU
* Patient under State Medical Aid
* Known pregnancy or breastfeeding women
* Patient deprived of freedom, subject under a legal protective measure
* Any significant medical, psychiatric, or surgical condition that is uncontrolled and could endanger the subject's safety or limit adherence to the study's objectives and assessments

Outcomes:
Clinical response