Carcinoma, HepatocellularPREMETHEPNCT02847468
Multimetabolic 18F-Fluorodeoxyglucose (FDG) and 18F-Fluorocholine (FCH) Positron Emission Tomography (PET) as an Early Predictive Factor of Overall Survival in Patients With Advanced Hepatocellular Carcinoma Treated With Sorafenib
A study testing FDG Positron Emission Tomography and FCH Positron Emission Tomography in people with Carcinoma, Hepatocellular, run by Centre Georges Francois Leclerc at 1 site in France.
Trial summary
Hepatocellular carcinoma (HCC) is the third cause of death by cancer. For patients with inoperable advanced HCC, systematic therapy with Sorafenib, a multikinase inhibitor that has both antiangiogenic and antiproliferative effect, is the only therapeutic with proven survival benefits. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Carcinoma, Hepatocellular
- What is being tested?
- FDG Positron Emission Tomography and FCH Positron Emission Tomography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteFrance
- Study dates
- 27 Mar 2017to 23 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient older than 18 years
- Inoperable (advanced or metastatic) HCC histologically proven, or diagnosed according to the Barcelona criteria, determined to be candidate for Sorafenib therapy
- Lesion(s) able to be selected as targeted lesion(s) for modified RECIST criteria
- patient ineligible for curative treatment
- Child-Pugh liver function (platelet count superior or equal to 60X1 000 000 000per liter; haemoglobin superior or equal to 8,5g/dl
- Performance status more or equal to 2
Show all 9Show fewer
- Able to lie still for 45min for PET/CT scanning
- Able to understand and willing to signa written informed consent document
- Affiliated to the French social security social or beneficiary to such a regimen
Who cannot join
- Uncontrolled intercurrent illness with short-term life-threatening
- Pregnant or nursing woman
- Patient candidate to local/curative therapy of HCC (surgery, radiofrequency, transarterial chemoembolization, other local therapy).
- History of myocardial infarction less than 6 months before inclusion, uncontrolled hypertension, symptomatic congestive heart failure, anti-arrhythmic therapy (other than beta-blockers or digoxine)
- History of digestive bleeding less than 30 days before inclusion
- history of liver transplantation
- Previous treatment including Sorafenib Uncontrolled diabetes History of allergic reactions attributed to compounds of similar chemical or biologic composition to Fluorocholine, 18F-Fluorodeoxyglucose or Sorafenib
- Psychiatric illness/social situations that would limit compliance with the study requirements
Trial locations and contacts
1 site in 1 country.
About this study
Hepatocellular carcinoma (HCC) is the third cause of death by cancer. For patients with inoperable advanced HCC, systematic therapy with Sorafenib, a multikinase inhibitor that has both antiangiogenic and antiproliferative effect, is the only therapeutic with proven survival benefits. However, the efficacy of Sorafenib remains inconstant with a media overall survival of 10,7 months and a disease control rate only 35 to 43%; moreover, the overall incidence of treatment-related adverse event is 80%. Thus, it appears essential to find an early and accurate way to determine which patients are best responding to therapy in order to avoid the toxicity and cost of ineffective therapy.
Positron Emission Tomography (PET) with 18F-Fluorodeoxyglucose (FDG) has shown limited performance in the setting of HCC because of lack of sensitivity, in particular for well-differentiated tumours. However FDG uptake is related to proliferation rate and is an efficient marker survival following liver transplantation and selective internal radiation therapy. Moreover, the addition of a dynamic first-pass acquisition to the standard static scan provides better characterization of the tumour by adding information on tumour perfusion.
Read more
FCH which reflects lipids metabolism and specifically choline kinase activity, has shown promising results for detection of HCC when compared with FDG alone. Moreover, choline activity is related to a kinase pathway in mammalian cells, which is specifically inhibited by Sorafenib. However FCH uptake remains inconstant in HCC, and is related to tumour differentiation, by opposition to FDG. Therefore, several studies have suggested that combined evaluation of tumour glucose and lipid metabolism could play a complementary role for the evaluation of HCC in the setting of detection, staging and to predict recurrence following surgical resection. Thus, the investigator hypothesize that the combination of FDG and FCH may be the most accurate imaging evaluation of HCC.
Thus the aim of the present study is to determine the predictive performance of survival of lipid and glucose metabolism and perfusion changes during Sorafenib therapy in patients with advanced HCC.
- Conditions
- Carcinoma, Hepatocellular
- Being tested
- FDG Positron Emission Tomography, FCH Positron Emission Tomography
- Keywords
- FDG PET, FCH PET
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FDG Positron Emission TomographyOther
Subject will performed Positrons Emission tomography (PET) with 18F-Fluorocholine (FDG) before treatment with Sorafenib is started and 1 month after treatment started.
FCH Positron Emission TomographyOther
Subject will performed Positrons Emission tomography (PET) with 18F-Fluorocholine (FCH) before treatment with Sorafenib is started and 1 month after treatment started.
| Study group | Role | What they receive |
|---|---|---|
| FDG and FCH PET | Experimental | Patients will performed a TEP with 2 different radiotracer before treatment is started and 1 month after treatment has been started. Receives: Other: FDG Positron Emission Tomography; Other: FCH Positron Emission Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vital status
vital status will be death or alive
Measured: One year after study inclusion
Secondary outcomes (2)
Disease control
Absence of radiologic progression according to modified RECIST criteria
Measured: 4 months
Questionnaire of quality of life (EORTC QLQ-C30)
Questionnaire will be completed by subject at each clinical surveillance visit
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2016 (estimated)
- Study start27 Mar 2017
- Primary completion23 Dec 2021
- Study completion23 Dec 2021
Why it stopped: Insufficient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, HepatocellularStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Georges Francois Leclerc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre Fumoleau, Pr, Study director, Centre Georges François Leclerc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02847468
- Sponsor's protocol ID
- PREMETHEP
- Acronym
- PREMETHEP
- Status last verified
- Oct 2023
- First submitted
- 19 Jul 2016
- Last updated
- 11 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimetabolic 18F-Fluorodeoxyglucose (FDG) and 18F-Fluorocholine (FCH) Positron Emission Tomography (PET) as an Early Predictive Factor of Overall Survival in Patients With Advanced Hepatocellular Carcinoma Treated With Sorafenib
- ClinicalTrials.gov ID
- NCT02847468
- Acronym / sponsor ID
- PREMETHEP / PREMETHEP
- Conditions
- Carcinoma, Hepatocellular
- Keywords
- FDG PET, FCH PET
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient recruitment
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Centre Georges Francois LeclercUniversity, hospital or other
- Study start
- 27 Mar 2017 (actual)
- Primary completion
- 23 Dec 2021 (actual)
- Study completion
- 23 Dec 2021 (actual)
- First posted
- 28 Jul 2016 (estimated)
- 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.
Hepatocellular carcinoma (HCC) is the third cause of death by cancer. For patients with inoperable advanced HCC, systematic therapy with Sorafenib, a multikinase inhibitor that has both antiangiogenic and antiproliferative effect, is the only therapeutic with proven survival benefits. However, the efficacy of Sorafenib remains inconstant with a media overall survival of 10,7 months and a disease control rate only 35 to 43%; moreover, the overall incidence of treatment-related adverse event is 80%. Thus, it appears essential to find an early and accurate way to determine which patients are best responding to therapy in order to avoid the toxicity and cost of ineffective therapy.
Positron Emission Tomography (PET) with 18F-Fluorodeoxyglucose (FDG) has shown limited performance in the setting of HCC because of lack of sensitivity, in particular for well-differentiated tumours. However FDG uptake is related to proliferation rate and is an efficient marker survival following liver transplantation and selective internal radiation therapy. Moreover, the addition of a dynamic first-pass acquisition to the standard static scan provides better characterization of the tumour by adding information on tumour perfusion.
FCH which reflects lipids metabolism and specifically choline kinase activity, has shown promising results for detection of HCC when compared with FDG alone. Moreover, choline activity is related to a kinase pathway in mammalian cells, which is specifically inhibited by Sorafenib. However FCH uptake remains inconstant in HCC, and is related to tumour differentiation, by opposition to FDG. Therefore, several studies have suggested that combined evaluation of tumour glucose and lipid metabolism could play a complementary role for the evaluation of HCC in the setting of detection, staging and to predict recurrence following surgical resection. Thus, the investigator hypothesize that the combination of FDG and FCH may be the most accurate imaging evaluation of HCC.
Thus the aim of the present study is to determine the predictive performance of survival of lipid and glucose metabolism and perfusion changes during Sorafenib therapy in patients with advanced HCC.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FDG and FCH PET | Experimental | Other: FDG Positron Emission Tomography, Other: FCH Positron Emission TomographyPatients will performed a TEP with 2 different radiotracer before treatment is started and 1 month after treatment has been started. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patient older than 18 years
- Inoperable (advanced or metastatic) HCC histologically proven, or diagnosed according to the Barcelona criteria, determined to be candidate for Sorafenib therapy
- Lesion(s) able to be selected as targeted lesion(s) for modified RECIST criteria
- patient ineligible for curative treatment
- Child-Pugh liver function (platelet count superior or equal to 60X1 000 000 000per liter; haemoglobin superior or equal to 8,5g/dl
Key exclusion criteria (8 listed)
- Uncontrolled intercurrent illness with short-term life-threatening
- Pregnant or nursing woman
- Patient candidate to local/curative therapy of HCC (surgery, radiofrequency, transarterial chemoembolization, other local therapy).
- History of myocardial infarction less than 6 months before inclusion, uncontrolled hypertension, symptomatic congestive heart failure, anti-arrhythmic therapy (other than beta-blockers or digoxine)
- History of digestive bleeding less than 30 days before inclusion
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 |
|---|---|---|
| FDG Positron Emission TomographySubject will performed Positrons Emission tomography (PET) with 18F-Fluorocholine (FDG) before treatment with Sorafenib is started and 1 month after treatment started. | Other | FDG and FCH PET |
| FCH Positron Emission TomographySubject will performed Positrons Emission tomography (PET) with 18F-Fluorocholine (FCH) before treatment with Sorafenib is started and 1 month after treatment started. | Other | FDG and FCH PET |
Primary outcome
Vital status
Time frame: One year after study inclusion
vital status will be death or alive
2 secondary outcomes
Disease control
Time frame: 4 months
Questionnaire of quality of life (EORTC QLQ-C30)
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Insufficient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2023.
- Individual participant dataSharing planned: No
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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.
Pierre Fumoleau, Pr study director
Centre Georges François Leclerc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FDG Positron Emission Tomography and FCH Positron Emission Tomography in people with Carcinoma, Hepatocellular, run by Centre Georges Francois Leclerc at 1 site 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 9 inclusion and 8 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: stopped early, as of the sponsor's last update on 11 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study was stopped early (reason given: Insufficient recruitment). Results are not available in the source record.
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?
Vital status (time frame: One year after study inclusion). 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 11 Oct 2023.