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

Phase 4

Terminated

Conditions: Hepatocellular Carcinoma

Interventions: Drug: Gadoterate meglumine

Registration Number: NCT01806740

Lead Sponsor: Guerbet

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 37

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Gadoterate meglumine	Gadoterate meglumine	there is one single arm of patients (no comparative arm)

Primary Outcome Measures

Name	Time	Method
Correlation Coefficient Between DCE-MRI Perfusion Parameters and the Response of Target Lesions to Sorafenib	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 Outcome Measures

Name	Time	Method
Correlation Coefficient Between DCE-MRI Perfusion Parameters at Baseline and Overall Survival	1 year	To evaluate the correlation between DCE-MRI perfusion parameters (Ktrans, AUC, ve, kep, T1, wash-in, washout) at baseline and overall survival. The overall survival was calculated from the patient's survival status recorded one year after initiation of the sorafenib treatment. The correlation analyses were done using Pearson or Spearman correlation coefficient.
Correlation Coefficient Between DCE-MRI Perfusion Parameters at Baseline and Progression Free Survival	1 year	To evaluate the correlation between DCE-MRI perfusion parameters (Ktrans, AUC, ve, kep, T1, wash-in, washout) at baseline and progression free survival. The progression free survival was calculated from the patient's survival status and tumor progression status recorded one year after initiation of the sorafenib treatment. The correlation analyses were done using Pearson or Spearman correlation coefficient.
Correlation Coefficient Between DCE-MRI Perfusion Parameters at Baseline and Time to Progression	1 year	To evaluate the correlation between DCE-MRI perfusion parameters (Ktrans, AUC, ve, kep, T1, wash-in, washout) at baseline and time to progression. The time to progression was calculated from the patient's survival status and tumor progression status recorded one year after initiation of the sorafenib treatment. The correlation analyses were done using Pearson or Spearman correlation coefficient.