NCT Number: NCT02824185
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
CHU de Grenoble, Servide d'Hépato-gastro-entérologie, La Tronche, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 24 months post-treatment
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.
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.
Time frame: FCH-PET/MRI examination, up to 2 months before treatment
Time frame: FCH-PET/MRI examination, up to 2 months before treatment
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).
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
Time frame: 24 months post-treatment
Hospices Civils de Lyon
Other
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
Acronym: TOMIC
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