Hepatocellular CarcinomaTEP CARENCT04792801
PET TDM FDG-Choline as a Decision-making Tool for Routine Care on the Liver Transplant List for HCC
An observational study of Hepatocellular Carcinoma and Liver Transplant, run by University Hospital, Lille at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma, Liver Transplant
- What is being tested?
- PET TDM FDG-Choline
- Type of treatment
- Surgery or procedure
- How many people
- 108 participants
- Where
- 2 sitesFrance
- Study dates
- 22 Jun 2021to 5 Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Liver transplant candidates for hepatocellular carcinoma, validated in PCR and having an AFP score ≤ 2.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
About this study
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
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
- Being tested
- PET TDM FDG-Choline
- Keywords
- Hepatocellular carcinoma, Liver transplantation, PET CT, Fluorodeoxyglucose, Fluorodeoxyglucose, Choline
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET TDM FDG-CholineRadiation
Performing an FDG TDM PET and a Choline TDM PET at two different times
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Radiation: PET TDM FDG-Choline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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):
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.
Measured: 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)
Measured: 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
Measured: 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
Measured: 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.
Measured: Last aFP value before LT or WL dropout. Maximal estimated time before transplant: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2021
- Study start22 Jun 2021
- Primary completion5 Jun 2028 (estimated)
- Study completion5 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume Lassailly, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04792801
- Sponsor's protocol ID
- 2019_34
- Other IDs
- 2020-A000998-31
- Acronym
- TEP CARE
- Status last verified
- Jul 2026
- First submitted
- 8 Mar 2021
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04792801
- Acronym / sponsor ID
- TEP CARE / 2019_34
- Conditions
- Hepatocellular Carcinoma, Liver Transplant
- Keywords
- Hepatocellular carcinoma, Liver transplantation, PET CT, Fluorodeoxyglucose, Fluorodeoxyglucose, Choline
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 108 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 22 Jun 2021 (actual)
- Primary completion
- 5 Jun 2028 (estimated)
- Study completion
- 5 Jun 2028 (estimated)
- First posted
- 11 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with HCC and whose liver transplant plan has been validated | – | Radiation: PET TDM FDG-CholineProspective 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Liver transplant candidates for hepatocellular carcinoma, validated in PCR and having an AFP score ≤ 2.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET TDM FDG-CholinePerforming an FDG TDM PET and a Choline TDM PET at two different times | Radiation | Patients with HCC and whose liver transplant plan has been validated |
Primary outcome
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.
5 secondary outcomes
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)
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
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.
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.
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillaume Lassailly, MD principal investigator
University Hospital, Lille
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma and Liver Transplant, run by University Hospital, Lille at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.