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

University Hospital, Lille

Status: Enrolling

Conditions: Hepatocellular Carcinoma; Liver Transplant

Treatments: Radiation: PET TDM FDG-Choline

Study type: Observational

Funder types: Other

Identifiers

NCT04792801

2020-A000998-31 (Other Identifier)

2019_34

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

100 participants in 1 patient group

Patients with HCC and whose liver transplant plan has been validated

Description:

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.

Treatment:

Radiation: PET TDM FDG-Choline