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NCT Number: NCT04792801

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

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.

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Liver Transplant Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hop Claude Huriez Chu Lille, Lille, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PET TDM FDG-Choline

Radiation

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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

  3. 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.

  4. 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. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

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

Acronym: TEP CARE

Important dates

Study start
2021
Primary completion
2028
Study completion
2028
First posted
Mar 11, 2021
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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