Combined Fluorocholine Positron Emission Tomography and Magnetic Resonance Imaging (FCH-PET/MRI) in Curative Treatment of a Hepatocellular Carcinoma (TOMIC)

Civil Hospices of Lyon

Status

Completed

Conditions

Patients Eligible to a Curative Treatment for Primary HCC

Treatments

Device: PET/MRI system (SIEMENS AG, Munich, Germany; distributed in France by SIEMENS S.A.S, Saint-Denis, France)

Study type

Interventional

Funder types

Other

Identifiers

NCT02824185

69HCL16_0133

Details and patient eligibility

About

Hepatocellular carcinoma (HCC) is the fifth most common cancer in terms of incidence and the second in terms of mortality. At an early stage, which is based on a low number and size of liver nodules and the absence of extra-hepatic locations (Milan criteria), a curative treatment can be performed, i.e. liver transplantation, surgical resection, or thermo-ablation. These treatments can lead to severe complications, so patients benefiting from them must be carefully selected. The correct identification of all HCC lesions at the time of the therapeutic decision is crucial. MRI is the reference examination for diagnosis but its field of exploration is limited to the upper abdominal area and its sensitivity decreases for nodules of less than two centimetres. Such lesions could actually be HCC that will cause early post-operative progression.

Positron Emission Tomography (PET; functional imaging) with fluorodeoxyglucose can provide prognostic information but impacts initial staging in less than 5% of cases. However, PET with fluorocholine (FCH), available in France since 2010, could detect intra- and extra-hepatic HCC lesions not identified by conventional imaging, potentially impacting patient management (e.g. 52% of patients in a small case study).

FCH-PET/MRI could therefore be the ideal examination for the initial staging of HCC, combining in a single multimodality investigation the reference morphological imaging technique and an efficient functional one. The hypothesis of this study is that FCH-PET/MRI is able to detect, in patients eligible for curative treatment, additional preoperative intra- and extra-hepatic early or metastatic HCC unseen or equivocal with conventional imaging (CT and MRI) and responsible for recurrence or disease progression at 6 months.

Enrollment

61 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age ≥18 years old
Primary HCC proven by histological or imaging examinations (LIRAD 4 or 5)
Eligible for curative treatment (Barcelona criteria) i.e. hepatic transplantation according to Milan criteria, surgical resection, or thermo-ablation, according to a multidisciplinary decision care committee
Affiliated to, or a beneficiary of, a social security system
Written informed consent.

Exclusion criteria

Patient refusing curative treatment
Patient with HCC not eligible for curative treatment according to conventional imaging (CT, MRI)
Patient with performance status >1
Contraindication to MRI
Pregnant or lactating woman
Adult ward of court (under guardianship or trusteeship)