Combined Fluorocholine Positron Emission Tomography and Magnetic Resonance Imaging (FCH-PET/MRI) in Curative Treatment of a Hepatocellular Carcinoma (TOMIC)
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|ClinicalTrials.gov Identifier: NCT02824185|
Recruitment Status : Recruiting
First Posted : July 6, 2016
Last Update Posted : January 13, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Patients Eligible to a Curative Treatment for Primary HCC||Device: PET/MRI system (SIEMENS AG, Munich, Germany; distributed in France by SIEMENS S.A.S, Saint-Denis, France)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||82 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||June 14, 2017|
|Estimated Primary Completion Date :||December 14, 2021|
|Estimated Study Completion Date :||August 14, 2023|
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.
- 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.
- Progression-free survival rates of patients with and without additional lesions visible on FCH-PET/MRI [ Time Frame: 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.
- 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.
- 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 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 ]
- 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).
- 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
- Costs avoided and induced by performing FCH-PET/MRI [ Time Frame: 24 months post-treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02824185
|Contact: Pierre-Jean VALETTE, Pr||(0)4 72 11 75 44 ext +email@example.com|
|Contact: Soumia BAYARASSOU, Clinical Research Assistant||(0)4 72 11 51 69 ext +firstname.lastname@example.org|
|CHU de Grenoble, Servide d'Hépato-gastro-entérologie||Recruiting|
|La Tronche, France, 38700|
|Contact: Thomas DECAENS, MD|
|Principal Investigator: Thomas DECAENS, MD|
|HCL, Hôpital Edouard Herriot, service d'hépato-gastro-entérologie||Recruiting|
|Lyon, France, 69003|
|Contact: Jérôme DUMORTIER, MD|
|Principal Investigator: Jérôme DUMORTIER, MD|
|Sub-Investigator: Pierre-Jean VALETTE, MD|
|Sub-Investigator: Hélène GIMONET, MD|
|HCL, Hôpital de la Croix-Rousse, service d'Hépato-gastro-entérologie||Recruiting|
|Lyon, France, 69004|
|Contact: Philippe MERLE, MD|
|Principal Investigator: Philippe MERLE, MD|
|Hospices Civils de Lyon, Groupement Hospitalier Lyon Sud, Service de radiologie digestive||Active, not recruiting|
|Pierre-Bénite, France, 69495|