Hepatocellular Carcinoma Clinical Trial
Official title:
Phase IV Study of DCE-MRI Using Dotarem® in Evaluation of Therapeutic Response to Sorafenib in Patients With Advanced Stage HCC
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.
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.
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