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

May 20, 2026 updated by: University Hospital, Lille

Evaluation of PET TDM FDG-Choline as a Decision-making Tool for Routine Care on Inclusion on the Liver Transplant List for Hepatocellular Carcinoma

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

108

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lille, France, 59037
        • Hop Claude Huriez Chu Lille

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Liver transplant candidates for hepatocellular carcinoma, validated in PCR and having an AFP score ≤ 2.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Radiation: PET TDM FDG-Choline
Performing an FDG TDM PET and a Choline TDM PET at two different times

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of patients reclassified for lymph node fixation (N +) and / or extrahepatic extension (M +) after PET TDM FDG-Choline
Time Frame: through study completion an average of 1 year
Composite endpoint corresponding to the rate of patients reclassified for lymph node fixation (N +) and / or extrahepatic extension (M +) after PET TDM FDG-Choline with a negative standard assessment (thoracic CT, abdominal imaging by CT or MRI) or patient not included on the list due to locally advanced disease not compatible with the graft (AFP score ≥ 3 or infiltrating HCC) not identified by the standard assessment.
through study completion an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Characteristics of PET FDG-Choline PET binding (defined as below) and the degree of tumor differentiation of HCC on the hepatectomy specimen (well differentiated/ moderate differentiation/ undifferentiated):
Time Frame: At time of liver transplantation (comparison of TEP baseline and HCC obtained on the hepatectomy analysis)
Presence/absence of a double fixation TEP FDG and TEP Choline B. Presence of a single TEP FDG or Choline binding C. No FDG-Choline binding.
At time of liver transplantation (comparison of TEP baseline and HCC obtained on the hepatectomy analysis)
Binding intensity (SUV) of PET TDM FDG-Choline and the degree of tumor differentiation of HCC on the hepatectomy specimen (well differentiated/ moderate differentiation/ undifferentiated)
Time Frame: At time of liver transplantation (comparison of TEP baseline and HCC obtained on the hepatectomy analysis
At time of liver transplantation (comparison of TEP baseline and HCC obtained on the hepatectomy analysis
Binding intensity (SUV) of PET TDM FDG-Choline and risk of waiting list dropout for progression of HCC outside transplant criteria based on aFP score
Time Frame: Analysis on the access to liver transplantation after 24 month.
Analysis on the access to liver transplantation after 24 month.
Binding intensity (SUV) of PET TDM FDG-Choline and risk of HCC recurrence in the 5 years after LT
Time Frame: 5 years after transplantation. Screening for HCC recurrence with CT and abdominal scan every 6 month during 5 years.
5 years after transplantation. Screening for HCC recurrence with CT and abdominal scan every 6 month during 5 years.
Binding intensity (SUV) of PET TDM FDG-Choline and the last aFP value before transplantation or WL dropout.
Time Frame: Last aFP value before LT or WL dropout. Maximal estimated time before transplant: 2 years
Last aFP value before LT or WL dropout. Maximal estimated time before transplant: 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Investigators

  • Principal Investigator: Guillaume Lassailly, MD, University Hospital, Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 22, 2021

Primary Completion (Estimated)

June 5, 2028

Study Completion (Estimated)

June 5, 2028

Study Registration Dates

First Submitted

March 8, 2021

First Submitted That Met QC Criteria

March 10, 2021

First Posted (Actual)

March 11, 2021

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 20, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019_34
  • 2020-A000998-31 (Other Identifier: ID-RCB number,ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hepatocellular Carcinoma

Clinical Trials on PET TDM FDG-Choline

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saint Lucia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe