NCT01806740

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

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Guerbet · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	Gadoterate meglumine	Gadoterate meglumine was administered at a dose of 0.1 mmol/kg (0.2 mL/kg) using a power injector, in an intravenous bolus at a rate of 3 mL/sec.

Timeline

• Start date: 2013-05-09
• Primary completion: 2015-10-12
• Completion: 2015-10-12
• First posted: 2013-03-07
• Last updated: 2019-08-08
• Results posted: 2019-08-08

Locations

1 site across 1 country: South Korea