Status:
COMPLETED
Combination PET With 18F-fluorodeoxyglucose (18F-FDG) and 18 F-choline in Patient With HCC
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Ministry of Health, France
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ...
Detailed Description
Hepatocellular carcinoma (HCC) is one of the leading causes of death from cancer worldwide, developing on cirrhosis in 90% of cases. The prognosis of patients with HCC remains poor with an overall sur...
Eligibility Criteria
Inclusion
- 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
- 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 woman
- Patient under tutorship or curatorship or safeguard of justice
- Known allergy to iodine
- Patient deprived of liberty by judicial or administrative decision
- Patients with care "State Medical Aid"
Key Trial Info
Start Date :
July 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 28 2023
Estimated Enrollment :
230 Patients enrolled
Trial Details
Trial ID
NCT04391348
Start Date
July 17 2020
End Date
April 28 2023
Last Update
November 18 2023
Active Locations (1)
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1
NAULT
Bobigny, France, 93000