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

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Beaujon hospital
RECRUITING
Clichy
Service de Médecine Nucléaire, Hôpital Beaujon
RECRUITING
Clichy
CHU Nantes
ACTIVE_NOT_RECRUITING
Nantes
Service de Médecine Nucléaire, CHU de Nantes
RECRUITING
Nantes
Service de medecine nucleaire, Hôpital Bichat
ACTIVE_NOT_RECRUITING
Paris
Contact Information
Primary
Valérie VILGRAIN
valerie.vilgrain@aphp.fr
00-33-1-40-87-53-58
Backup
Françoise KRAEBER - BODERE
francoise.bodere@chu-nantes.fr
00-33-2-40-08-41-45
Time Frame
Start Date: 2024-07-18
Estimated Completion Date: 2029-09
Participants
Target number of participants: 180
Treatments
Experimental: PET-MRI
PET-MRI added in care pathway
Related Therapeutic Areas
Sponsors
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov