Combination PET With 18F-fluorodeoxyglucose (18F-FDG) and 18 F-choline in Patient With HCC
PET-HCC01
Prospective Study Evaluating the Combination of Positron Emission Tomography (PET) With 18F-FDG and 18 F-Fluorocholine for Optimization of Staging and Treatment Modification in Patients With Hepatocellular Carcinoma
2 other identifiers
interventional
230
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable hepatocellular-carcinoma
Started Jul 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 4, 2020
CompletedFirst Posted
Study publicly available on registry
May 18, 2020
CompletedStudy Start
First participant enrolled
July 17, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 28, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 28, 2023
CompletedNovember 18, 2023
November 1, 2023
2.8 years
May 4, 2020
November 15, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (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
The primary objective of the study will be evaluated by the proportion of patients with a first diagnosis of HCC whose treatment initially planned in a multidisciplinary consultation meeting is modified by the combined use of PET-TDMs at 18F-FDG and 18F-Fluorocholine in combination with conventional imaging compared to conventional imaging alone.
through multidisciplinary concertation meeting an average of 3 days
Secondary Outcomes (6)
Number of patients for whom a curative treatment initially planned on the basis of conventional imaging has been modified, for a loco-regional or systemic palliative treatment by the experimental procedure (18F-FDG and 18F PET-CTs) -Fluorocholine)
through multidisciplinary concertation meeting an average of 3 days
Modification of the BCLC tumor stage initially evaluated by conventional imaging on the basis of each PET-TDM (18F-FDG alone, 18F-Fluorocholine alone) separately and then the combination of both (combination of PET-TDMs with 18F-FDG and 18F-Fluorocholine
through multidisciplinary concertation meeting an average of 3 days
Identification as a HCC of at least one additional tumour lesion using the experimental procedure (each PET-TDM separately and then the combination of both) compared to conventional imaging alone
through multidisciplinary concertation meeting an average of 3 days
Description of the differences in diagnostic performance of the experimental procedure compared to the diagnostic gold standard (non-invasive criteria and/or tumor histology)
through multidisciplinary concertation meeting an average of 3 days
Cost-effectiveness between PET-TDMs at 18F-FDG and 18F-Fluorocholine associated with conventional imaging versus conventional imaging alone
through multidisciplinary concertation meeting an average of 3 days
- +1 more secondary outcomes
Study Arms (1)
PET-TDM
EXPERIMENTALPET-TDM with 18F-FDG and PET-TDM with 18F-fluorocholine
Interventions
Experimental procedure combining PET-TDM with 18F-FDG and PET-TDM with 18F-Fluorocholine
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- 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
- 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"
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NAULT
Bobigny, 93000, France
Related Publications (4)
Nault JC, Sutter O, Nahon P, Ganne-Carrie N, Seror O. Percutaneous treatment of hepatocellular carcinoma: State of the art and innovations. J Hepatol. 2018 Apr;68(4):783-797. doi: 10.1016/j.jhep.2017.10.004. Epub 2017 Oct 13.
PMID: 29031662BACKGROUNDCadier B, Bulsei J, Nahon P, Seror O, Laurent A, Rosa I, Layese R, Costentin C, Cagnot C, Durand-Zaleski I, Chevreul K; ANRS CO12 CirVir and CHANGH groups. Early detection and curative treatment of hepatocellular carcinoma: A cost-effectiveness analysis in France and in the United States. Hepatology. 2017 Apr;65(4):1237-1248. doi: 10.1002/hep.28961. Epub 2017 Feb 8.
PMID: 28176349BACKGROUNDBertagna F, Bertoli M, Bosio G, Biasiotto G, Sadeghi R, Giubbini R, Treglia G. Diagnostic role of radiolabelled choline PET or PET/CT in hepatocellular carcinoma: a systematic review and meta-analysis. Hepatol Int. 2014 Oct;8(4):493-500. doi: 10.1007/s12072-014-9566-0. Epub 2014 Sep 3.
PMID: 26202754BACKGROUNDNault JC, Boubaya M, Wartski M, Dohan A, Pol S, Pop G, Soussan M, Sutter O, Costentin C, Roux J, Sengel C, Lequoy M, Montravers F, Menu Y, Pageaux GP, Goulart DM, Guiu B, Luciani A, Nahon P, Dioguardi Burgio M, Wagner M, Maksud P, Mule S, Allaire M, Sidali S, Coilly A, Besson FL, Lewin M, Regnault H, Hollande C, Amaddeo G, Ronot M, Ganne-Carrie N, Itti E, Bloch-Queyrat C, Levy V, Lebtahi R, Chalaye J, Bouattour M. [18F]fluorodeoxyglucose and [18F]fluorocholine PET-CT for staging optimisation and treatment modification in hepatocellular carcinoma (PET-HCC01): a prospective multicentre study. Lancet Gastroenterol Hepatol. 2025 Apr;10(4):306-314. doi: 10.1016/S2468-1253(25)00011-1. Epub 2025 Feb 20.
PMID: 39987937DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jean Charles NAULT, PhD
Assistance Publique - Hôpitaux Paris
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 4, 2020
First Posted
May 18, 2020
Study Start
July 17, 2020
Primary Completion
April 28, 2023
Study Completion
April 28, 2023
Last Updated
November 18, 2023
Record last verified: 2023-11