Clinical trial NCT02824185: Combined Fluorocholine Positron Emission Tomography and Magnetic Resonance Imaging (FCH-PET/MRI) in Curative Treatment of a Hepatocellular Carcinoma
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patients Eligible to a Curative Treatment for Primary HCC
Keywords: FCH-PET/MRI
primary HCC
curative treatment
resection
thermo-ablation
transplantation
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-07-06
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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)

Primary outcomes:
measure: Specificity of FCH-PET/MRI for the detection of preoperative lesions
timeFrame: 6 months post-treatment
Secondary outcomes:
measure: Progression-free survival rates of patients with and without additional lesions visible on FCH-PET/MRI
timeFrame: 24 months post-treatment
measure: Sensitivity of preoperative FCH-PET/MRI for detecting HCC lesions
timeFrame: 6 months post-treatment
measure: Positive and negative predictive value of FCH-PET/MRI
timeFrame: 6 months post-treatment
measure: Specificity and sensitivity of FCH-PET/MRI compared with preoperative MRI findings for extra-hepatic HCC lesions and for intra-hepatic HCC lesions
timeFrame: FCH-PET/MRI examination, up to 2 months before treatment
measure: FCH-PET/MRI findings (positive or negative, and standardized uptake value ratio between lesions and liver or tissue) compared to HCC differentiation by histopathology
timeFrame: FCH-PET/MRI examination, up to 2 months before treatment
measure: Costs of performing FCH-PET/MRI
timeFrame: FCH-PET/MRI examination, up to 2 months before treatment
measure: Incremental cost-effectiveness ratio
timeFrame: 24 months post-treatment
measure: Costs avoided and induced by performing FCH-PET/MRI
timeFrame: 24 months post-treatment
Other outcomes:
Locations:
city: La Tronche
country: France
facility: CHU de Grenoble, Servide d'Hépato-gastro-entérologie
city: Lyon
country: France
facility: HCL, Hôpital Edouard Herriot, service d'hépato-gastro-entérologie
city: Lyon
country: France
facility: Hospices Civils de Lyon, Hôpital Edouard Herriot, service d'hépato-gastro-entérologie
city: Lyon
country: France
facility: HCL, Hôpital de la Croix-Rousse, service d'Hépato-gastro-entérologie
Study officials:
References: