PREMETHEP : Multimetabolic 18F-Fluorodeoxyglucose (FDG) and 18F-Fluorocholine (FCH) Positron Emission Tomography (PET) as an early predictive factor of overall survival in patients with advanced hepatocellular carcinoma treated with sorafenib. - PREMETHEP

Centre Georges-François Leclerc0 个研究点目标入组 87 人开始时间: 2016年3月14日最近更新: 2016年4月11日

适应症

试验速览

暂无简介。

•- Patients older than 18 years.
•- Inoperable (advanced or metastatic) HCC histologically proven, or diagnosed according to the Barcelona criteria, determined to be candidate for Sorafenib therapy.
•- Lesion(s) able to be selected as target lesion(s) for modified RECIST criteria.
•- Patient ineligible for curative treatment (BCLC score B or C).
•- Child-Pugh liver function class A.
•- No obvious contraindication for Sorafenib.
•- Adequate hematologic function (platelet count =60.109/l; hemoglobin =8.5 g/dl; INR =2.3).
•- ECOG status =2.
•- Able to lie still for 45 min for PET/CT scanning.
•- Able to understand and willing to sign a written informed consent document.
•- Affiliated to the Sécurité Sociale or beneficiary to such a regimen
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 87
•F.1.3 Elderly (>=65 years)
•F.1.3.1 Number of subjects for this age range

•- Uncontrolled intercurrent illness with short-term life-threatning.
•- Patient candidate to local/curative therapies of HCC (surgery, radiofrequency, transarterial chemoembolization, other local therapy).
•- Pregnant or nursing woman.
•- History of myocardial infarction less than 6 months before inclusion, uncontrolled hypertension, symptomatic congestive heart failure, anti-arythmic therapy (other than beta-blockers or digoxine).
•- History of digestive bleeding less than 30 days before inclusion.
•- History of liver transplantation.
•- Previous treatment including Sorafenib.
•- Uncontrolled diabetes.
•- History of allergic reactions attributed to compounds of similar chemical or biological composition to 18F-Fluorocholine, 18F-Fluorodeoxyglucose or Sorafenib.
•- Psychiatric illness/social situations that would limit compliance with the study requirements.

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