Combination PET With 18F-fluorodeoxyglucose (18F-FDG) and 18 F-choline in Patient With HCC (PET-HCC01)

Assistance Publique - Hôpitaux de Paris

Status

Completed

Conditions

Hepatocellular Carcinoma

Treatments

Radiation: PET-TDM with 18F-FDG + PET-TDM with 18F-fluorocholine

Study type

Interventional

Funder types

Other

Identifiers

NCT04391348

APHP180570

2019-A02031-56 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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 survival of around 10% at 5 years for all tumor stages combined. The diagnosis of HCC relies on non-invasive conventional imaging criteria (computed tomography [CT] and/or magnetic resonance imaging [MRI]) and/or histology. Conventional imaging (liver CT and/or MRI and lung CT) enables HCC staging according to the Barcelona Clinical Liver Cancer (BCLC) system, linking each stage to therapeutic modalities. Accurate staging with reliable imaging methods is therefore crucial to determine the best treatment strategy. The principal objective is to demonstrate that the identification of new tumor lesions by an experimental procedure combining 18F-FDG and 18F-Fluorocholine PET-CT scans in patients with HCC, modifies the initially planned therapeutic strategy of a curative treatment palliative treatment, from locoregional palliative treatment to systemic palliative treatment.

Enrollment

230 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 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"