Phase IV Study of DCE-MRI Using Dotarem® in Evaluation of Therapeutic Response to Sorafenib in Patients With Advanced Stage HCC
Secondary objectives :
1. To evaluate the value of percent change of DCE-MRI/AFP/DWI from baseline to follow up
at 1 or 2 weeks in prediction of overall survival, progression-free survival, and time
to progression
2. To evaluate the value of baseline DCE-MRI/AFP/DWI in prediction of overall survival,
progression-free survival, and time to progression.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
correlation between % change of DCE-MRI perfusion parameters
To evaluate the correlation between % change of DCE-MRI perfusion parameters (Ktrans, AUC, kep, ve,Etc.) from baseline to follow up image at 1 & 2 weeks and the response to Sorafenib assessed by mRECIST at 2 months after initiation of treatment
3 months
No
Jeong Min Lee, Ph.D
Principal Investigator
Seoul National University Hospital
Korea: Institutional Review Board
DGD-44-057
NCT01806740
March 2013
August 2015
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