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

NCT ID: NCT02824185

Last Updated: 2023-10-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-14
• Study Completion Date: 2023-01-02

Brief Summary

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.

Conditions

Patients Eligible to a Curative Treatment for Primary HCC

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

FCH-PET/MRI

FCH-PET/MRI exam performed in addition to the usual examinations for monitoring hepatocellular carcinoma.

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

A PET/MRI examination will be performed once for all included patients, using injected fluorocholine, with a dose of 3MBq/kg, up to 2 months before HCC treatment.

Interventions

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

A PET/MRI examination will be performed once for all included patients, using injected fluorocholine, with a dose of 3MBq/kg, up to 2 months before HCC treatment.

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU de Grenoble, Servide d'Hépato-gastro-entérologie

La Tronche, , France

HCL, Hôpital Edouard Herriot, service d'hépato-gastro-entérologie

Lyon, , France

Hospices Civils de Lyon, Hôpital Edouard Herriot, service d'hépato-gastro-entérologie

Lyon, , France

HCL, Hôpital de la Croix-Rousse, service d'Hépato-gastro-entérologie

Lyon, , France

Countries

France

Other Identifiers

69HCL16_0133

Identifier Type: -

Identifier Source: org_study_id