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

October 30, 2023 updated by: Hospices Civils de Lyon

Potential Interest of Combined Fluorocholine Positron Emission Tomography and Magnetic Resonance Imaging (FCH-PET/MRI) for the Selection of Patients Proposed for Curative Treatment of a Hepatocellular Carcinoma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • La Tronche, France, 38700
        • CHU de Grenoble, Servide d'Hépato-gastro-entérologie
      • Lyon, France, 69003
        • HCL, Hôpital Edouard Herriot, service d'hépato-gastro-entérologie
      • Lyon, France, 69003
        • Hospices Civils de Lyon, Hôpital Edouard Herriot, service d'hépato-gastro-entérologie
      • Lyon, France, 69004
        • HCL, Hôpital de la Croix-Rousse, service d'Hépato-gastro-entérologie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FCH-PET/MRI
FCH-PET/MRI exam performed in addition to the usual examinations for monitoring hepatocellular carcinoma.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Specificity of FCH-PET/MRI for the detection of preoperative lesions
Time Frame: 6 months post-treatment
Specificity of FCH-PET/MRI for the detection of preoperative lesions not visible with conventional imaging techniques and confirmed as being HCC Specificity of preoperative FCH-PET/MRI will be calculated as a ratio of the number of patients with negative FCH-PET/MRI and no additional lesions in histopathology and/or no progressive lesions confirmed at follow-up, to the total number of patients with no additional lesions in histopathology and/or no progressive lesions confirmed at follow-up.
6 months post-treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival rates of patients with and without additional lesions visible on FCH-PET/MRI
Time Frame: 24 months post-treatment
24 months post-treatment
Sensitivity of preoperative FCH-PET/MRI for detecting HCC lesions
Time Frame: 6 months post-treatment
Sensitivity of preoperative FCH-PET/MRI will be determined as a ratio of the number of patients with positive imaging and additional lesions in histopathology and/or progressive lesions confirmed at follow-up, to the total number of patients with additional lesions in histopathology and/or progressive lesions confirmed at follow-up.
6 months post-treatment
Positive and negative predictive value of FCH-PET/MRI
Time Frame: 6 months post-treatment
Positive predictive value will be calculated from the number of patients with positive imaging and additional lesions in histopathology and/or progressive lesions confirmed at follow-up, and the total number of patients with positive imaging. Negative predictive value will be calculated from the number of patients with negative imaging and no additional lesions in histopathology and/or progressive lesions confirmed at follow-up, and the total number of patients with negative imaging.
6 months post-treatment
Specificity and sensitivity of FCH-PET/MRI compared with preoperative MRI findings for extra-hepatic HCC lesions and for intra-hepatic HCC lesions
Time Frame: FCH-PET/MRI examination, up to 2 months before treatment
FCH-PET/MRI examination, up to 2 months before treatment
FCH-PET/MRI findings (positive or negative, and standardized uptake value ratio between lesions and liver or tissue) compared to HCC differentiation by histopathology
Time Frame: FCH-PET/MRI examination, up to 2 months before treatment
FCH-PET/MRI examination, up to 2 months before treatment
Costs of performing FCH-PET/MRI
Time Frame: FCH-PET/MRI examination, up to 2 months before treatment
Direct observation of the realization of FCH-PET/MRI, to be able to reconstitute, in the most reliable way, the cost of the examination (micro-costing method).
FCH-PET/MRI examination, up to 2 months before treatment
Incremental cost-effectiveness ratio
Time Frame: 24 months post-treatment
Modeling of the patient pathway in terms of resource consumption and efficacy, including the completion of FCH-PET/MRI compared to the usual strategy of patient care
24 months post-treatment
Costs avoided and induced by performing FCH-PET/MRI
Time Frame: 24 months post-treatment
24 months post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 14, 2017

Primary Completion (Actual)

January 2, 2023

Study Completion (Actual)

January 2, 2023

Study Registration Dates

First Submitted

June 29, 2016

First Submitted That Met QC Criteria

July 1, 2016

First Posted (Estimated)

July 6, 2016

Study Record Updates

Last Update Posted (Actual)

October 31, 2023

Last Update Submitted That Met QC Criteria

October 30, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL16_0133

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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