Clinical trial NCT04792801: PET TDM FDG-Choline as a Decision-making Tool for Routine Care on the Liver Transplant List for HCC
Official 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hepatocellular Carcinoma
Liver Transplant
Keywords: Hepatocellular carcinoma
Liver transplantation
PET CT, Fluorodeoxyglucose
Fluorodeoxyglucose
Choline
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2021-03-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Liver transplant candidates for hepatocellular carcinoma, validated in PCR and having an AFP score ≤ 2.

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.


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.

Primary outcomes:
measure: Rate of patients reclassified for lymph node fixation (N +) and / or extrahepatic extension (M +) after PET TDM FDG-Choline
timeFrame: through study completion an average of 1 year
Secondary outcomes:
measure: 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):
timeFrame: At time of liver transplantation (comparison of TEP baseline and HCC obtained on the hepatectomy analysis)
measure: 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)
timeFrame: At time of liver transplantation (comparison of TEP baseline and HCC obtained on the hepatectomy analysis
measure: 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
timeFrame: Analysis on the access to liver transplantation after 24 month.
measure: Binding intensity (SUV) of PET TDM FDG-Choline and risk of HCC recurrence in the 5 years after LT
timeFrame: 5 years after transplantation. Screening for HCC recurrence with CT and abdominal scan every 6 month during 5 years.
measure: Binding intensity (SUV) of PET TDM FDG-Choline and the last aFP value before transplantation or WL dropout.
timeFrame: Last aFP value before LT or WL dropout. Maximal estimated time before transplant: 2 years
Other outcomes:
Locations:
city: Lille
country: France
facility: Hop Claude Huriez Chu Lille
Study officials:
affiliation: University Hospital, Lille
name: Guillaume Lassailly, MD
role: PRINCIPAL_INVESTIGATOR
References: