Phase IV Study of DCE-MRI Using Dotarem® in Evaluation of Therapeutic Response to Sorafenib in Patients With Advanced Stage HCC
Overview
- Phase
- Phase 4
- Intervention
- Gadoterate meglumine
- Conditions
- Hepatocellular Carcinoma
- Sponsor
- Guerbet
- Enrollment
- 37
- Locations
- 1
- Primary Endpoint
- Correlation Coefficient Between DCE-MRI Perfusion Parameters and the Response of Target Lesions to Sorafenib
- Status
- Terminated
- Last Updated
- 6 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Gadoterate meglumine
there is one single arm of patients (no comparative arm)
Intervention: Gadoterate meglumine
Outcomes
Primary Outcomes
Correlation Coefficient Between DCE-MRI Perfusion Parameters and the Response of Target Lesions to Sorafenib
Time Frame: 3 months
To evaluate the correlation between DCE-MRI perfusion parameters (Ktrans, AUC, ve, kep, T1, Wash-in, Washout) at baseline, week 1 and week 2, and the response of target lesions to sorafenib. * Ktrans: volume transfer constant between blood plasma and extravascular extracellular space * AUC : area under the curve of tissue gadolinium concentration-time * ve: fractional volume of extravascular extracellular space * kep: rate constant between extravascular extracellular space and blood plasma (=Ktrans/ve) * T1: longitudinal relaxation time * Wash-in: slope of the early enhancement curve * Washout: slope of the late enhancement curve The response of target lesions was assessed by mRECIST at 2 months after initiation of treatment (sorafenib). The correlation analyses were done using Pearson or Spearman correlation coefficient.
Secondary Outcomes
- Correlation Coefficient Between DCE-MRI Perfusion Parameters at Baseline and Overall Survival(1 year)
- Correlation Coefficient Between DCE-MRI Perfusion Parameters at Baseline and Progression Free Survival(1 year)
- Correlation Coefficient Between DCE-MRI Perfusion Parameters at Baseline and Time to Progression(1 year)