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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
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

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.


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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 82 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Progression-free survival rates of patients with and without additional lesions visible on FCH-PET/MRI [ Time Frame: 24 months post-treatment ]
  2. 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.

  3. 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.

  4. 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 ]
  5. 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 ]
  6. 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).

  7. 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

  8. Costs avoided and induced by performing FCH-PET/MRI [ Time Frame: 24 months post-treatment ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

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


Contacts
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Contact: Pierre-Jean VALETTE, Pr (0)4 72 11 75 44 ext +33 pierre-jean.valette@chu-lyon.fr
Contact: Soumia BAYARASSOU, Clinical Research Assistant (0)4 72 11 51 69 ext +33 soumia.bayarassou01@chu-lyon.fr

Locations
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France
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
Sponsors and Collaborators
Hospices Civils de Lyon
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02824185    
Other Study ID Numbers: 69HCL16_0133
First Posted: July 6, 2016    Key Record Dates
Last Update Posted: January 13, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospices Civils de Lyon:
FCH-PET/MRI
primary HCC
curative treatment
resection
thermo-ablation
transplantation
Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases