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

Hepatocellular Carcinoma Clinical Trial

— TEP CARE  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04792801
• Other study ID #: 2019_34
• Secondary ID: 2020-A000998-31
• Status: Recruiting
• Start date: June 22, 2021
• Est. completion date: June 2028

Study information

• Verified date: March 2022
• Source: University Hospital, Lille
• Contact: Guillaume Lassailly, MD
• Phone: 0320445962
• Email: guillaume.lassailly[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2028
• Est. primary completion date: June 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Liver Transplant

Intervention

Radiation:
• PET TDM FDG-Choline
Performing an FDG TDM PET and a Choline TDM PET at two different times

Locations

Country	Name	City	State
France	Hop Claude Huriez Chu Lille	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of patients reclassified for lymph node fixation (N +) and / or extrahepatic extension (M +) after PET TDM FDG-Choline	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	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):	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)
Secondary	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)		At time of liver transplantation (comparison of TEP baseline and HCC obtained on the hepatectomy analysis
Secondary	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		Analysis on the access to liver transplantation after 24 month.
Secondary	Binding intensity (SUV) of PET TDM FDG-Choline and risk of HCC recurrence in the 5 years after LT		5 years after transplantation. Screening for HCC recurrence with CT and abdominal scan every 6 month during 5 years.
Secondary	Binding intensity (SUV) of PET TDM FDG-Choline and the last aFP value before transplantation or WL dropout.		Last aFP value before LT or WL dropout. Maximal estimated time before transplant: 2 years