Combination PET With 18F-fluorodeoxyglucose (18F-FDG) and 18 F-choline in Patient With HCC (NCT04391348) | Clinical Trial Compass
CompletedNot Applicable
Combination PET With 18F-fluorodeoxyglucose (18F-FDG) and 18 F-choline in Patient With HCC
France230 participantsStarted 2020-07-17
Plain-language summary
The objective of this protocol is to obtain a better match between the actual staging and the proposed treatment in order to avoid inadequate treatments at risk of complications. In patients with HCC classified as BCLC A to C, the combination of 18F-FDG and 18F-Fluorocholine PET- TomoDensitoMetry (TDM) with conventional imaging would clinically significantly modify the therapeutic strategy initially planned by conventional imaging alone. This change in therapeutic strategy would be from curative to palliative treatment or from loco-regional palliative to systemic palliative treatment. 18F-FDG and 18F-Fluorocholine PET-CT scans will be performed after inclusion of the patient in the study and prior to multidisciplinary consultation meeting for treatment discussion.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients\> 18 years old
* First diagnosis of HCC (no previous treatments received)
* Diagnosis of HCC according to The European Association for the Study of the Liver (EASL) 2012 criteria by "non-invasive" imaging on cirrhosis or by histology on cirrhosis or non-cirrhotic liver
* BCLC tumor stage A to C (excluding BCLC C with extrahepatic metastases) according to conventional imaging
* Will be able to have a PET scanner within 4 weeks after the inclusion visit
* Ability to stay 20 minutes longer for PET-CT scans
* Need for oral, intra-uterine or mechanical contraception for women of childbearing age
* Written consent for participation in the study
* Having medical insurance coverage
Exclusion Criteria:
* Patients classified BCLC stage 0 (single HCC less than 2 cm)
* Patients classified as BCLC stage C with extrahepatic metastases
* Decreased cirrhosis (Child Pugh C) and / or patients with Eastern Cooperative Oncology Group (ECOG) Performance Status 2 to 4 not candidates for liver transplantation
* Uncontrolled diabetes (defined by blood glucose\> 1.7 g / L at the time of inclusion)
* Hypersensitivity to 18F Fluorocholine or 18F-FDG or any of the excipients
* Creatinine clearance \<40 mL / min
* Contraindication to MRI: pacemaker or implantable cardiac defibrillator not compatible with MRI, neurostimulator, cochlear implant, intracerebral ferromagnetic vascular clip, intraocular or cerebral metallic foreign bodies, insulin pump
* Pregnant or lactating …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Demonstrate that the identification of new tumour lesions by an experimental procedure combining PET-TDMs with 18F-FDG and 18F-Fluorocholine in patients with HCC modifies the initially planned therapeutic strategy
Timeframe: through multidisciplinary concertation meeting an average of 3 days