Spots Global Cancer Trial Database for DCE-MRI Using Dotarem® in Evaluation of Therapeutic Response to Sorafenib in Patients With Advanced Stage HCC

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Trial Identification

Brief Title: DCE-MRI Using Dotarem® in Evaluation of Therapeutic Response to Sorafenib in Patients With Advanced Stage HCC

Official Title: Phase IV Study of DCE-MRI Using Dotarem® in Evaluation of Therapeutic Response to Sorafenib in Patients With Advanced Stage HCC

Study ID: NCT01806740

Conditions

Hepatocellular Carcinoma

Interventions

Gadoterate meglumine

Study Description

Brief Summary: The main objective is to evaluate the value of dynamic contrast-enhanced Magnetic Resonance Imaging (DCE-MRI) in prediction of response of patients with hepatocellular carcinoma (HCC) to treatment with Sorafenib assessed by mRECIST.

Detailed Description: One of the secondary objectives was to evaluate the correlation between DCE-MRI perfusion parameters at baseline and: * Overall Survival (OS) * Progression-Free Survival (PFS) * Time to Progression (TTP) Three DCE-MRI examinations were done during the study: * at the enrolment and initiation of the sorafenib treatment * one week after initiation of the sorafenib treatment * two weeks after initiation of the sorafenib treatment DCE-MRI perfusion parameters were assessed by a centralized radiologist at baseline (corresponding to the day of enrolment and initiation of Sorafenib treatment), week 1 and week 2. According to mRECIST criteria, HCC lesions were evaluated on computed tomography images by two on-site radiologists at the time of enrolment and 8 weeks later (2 months). OS, PFS and TTP were calculated from survival and tumor progression data recorded one year after initiation of the sorafenib treatment.