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

NCT04792801 | Recruiting

• 2 other identifiers: 2019_342020-A000998-31
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma; Liver Transplant

Keywords

Hepatocellular carcinoma; Liver transplantation; PET CT, Fluorodeoxyglucose; Fluorodeoxyglucose; Choline

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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):

  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)

  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

  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

  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.

  Last aFP value before LT or WL dropout. Maximal estimated time before transplant: 2 years

Study Arms (1)

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

Interventions

PET TDM FDG-Choline RADIATION

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

Patients with HCC and whose liver transplant plan has been validated

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

Hop Claude Huriez Chu Lille

Lille, 59037, France

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

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

Study Officials

• Guillaume Lassailly, MD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guillaume Lassailly, MD

CONTACT

0320445962; guillaume.lassailly@chru-lille.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2021
• First Posted: March 11, 2021
• Study Start: June 22, 2021
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: March 15, 2022

Record last verified: 2022-03

Locations

FR (1)