PET TDM FDG-Choline as a Decision-making Tool for Routine Care on the Liver Transplant List for HCC

NCT ID: NCT04792801

Last Updated: 2022-03-15

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-06-22
• Study Completion Date: 2028-06-30

Brief Summary

HCC is the most common malignant liver tumor for which liver transplantation is one of the pivotal curative treatments. The best possible selection of patients who are candidates for transplantation is essential in the current context of a shortage of transplants. Performing a PET CT scan is not currently recommended in the pre-liver transplant workup for HCC. However, PET CT using in a complementary manner the FDG and Choline tracers appears promising in the management of HCC in view of its wide use in oncology and its major diagnostic and prognostic contribution compared to conventional imaging. In order to address this issue, a prospective cohort study including patients from the University Hospital of Rouen and Lille with hepatocellular carcinoma meeting the criteria for indication of liver transplantation validated in SPC will be set up, the main objective of which will be to assess the decision-making contribution of PET TDM FDG and Choline in addition to conventional imaging in the pre-transplant assessment.

Conditions

Hepatocellular Carcinoma; Liver Transplant

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with HCC and whose liver transplant plan has been validated

Prospective inclusion of patients who are candidates for a transplant for CHC at the University Hospital of Lille and Rouen whose transplant project has been validated with a AFP score ≤ 2.

The systematic performance of a PET-CT with FDG and a PET-CT with Choline in all patients. At the end of the entire assessment, the patients will be (or not) registered on the transplant list and, for the patients registered on the list, a follow-up will be carried out at the level of a specialized transplant consultation every 3 months at during which the alphafoetoprotein dosage and abdominal imaging will be updated, until liver transplantation.

PET TDM FDG-Choline

Intervention Type: RADIATION

Performing an FDG TDM PET and a Choline TDM PET at two different times

Interventions

PET TDM FDG-Choline

Performing an FDG TDM PET and a Choline TDM PET at two different times

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• Patient candidate for liver transplantation for hepatocellular carcinoma from the University Hospital of Lille and Rouen, whose therapeutic transplantation project has been validated and having an AFP score ≤ 2 (diagnosis of HCC defined on non-invasive imaging criteria according to the recommendations of EASL-EORTC 2012 or confirmed histologically).
• No opposition to participating in the study.
• Patient affiliated to a social security scheme

Exclusion Criteria

• Patient with an AFP score ≥ 3
• Patient contraindicated to PET FDG or Choline.
• Other tumor: Cholangiocarcinoma.
• Diabetes unbalanced HbA1c> 9%, and fasting hyperglycemia (> 2g / L) which does not allow the completion of the PET examination.
• Patient under guardianship or curatorship.
• Pregnant or breastfeeding woman.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Lille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guillaume Lassailly, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

Hop Claude Huriez Chu Lille

Lille, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Guillaume Lassailly, MD

Role: CONTACT

guillaume.lassailly@chru-lille.fr

0320445962 ext. +33

Facility Contacts

Role: primary

0320445962

Other Identifiers

2020-A000998-31

Identifier Type: OTHER

Identifier Source: secondary_id

2019_34

Identifier Type: -

Identifier Source: org_study_id