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

NCT ID: NCT01806740

Last Updated: 2019-08-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-09
• Study Completion Date: 2015-10-12

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.

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Gadoterate meglumine

there is one single arm of patients (no comparative arm)

Group Type: EXPERIMENTAL

Gadoterate meglumine

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

gadoteric acid; Dotarem

Eligibility Criteria

Inclusion Criteria

1. Male and female adult patients (age ≥ 20 years old)

2. Patients diagnosed with unresectable HCC [Child Pugh class A and major vascular invasion, extrahapatic metastasis, or progression after transarterial chemoembolization more than 2 times]

3. Presence of mRECIST target lesion within liver [lesion which can be classified as a RECIST measurable lesion (can be measured ≥ 1 cm in at least one dimension), lesion suitable for repeated measure, lesion showing intraluminal arterial enhancement on contrast-enhanced CT or MRI]

4. Patients planned to be treated with sorafenib

5. Patient with liver CT performed or planned to be performed within 4 weeks before initiation of sorafenib treatment

6. Patient with a life expectancy of 12 weeks or more

7. No previous treatment with sorafenib

8. Female patients who are surgically sterilized, or post-menopausal (minimum 12 months of amenorrhea) or who have a documented negative urine hCG test at screening

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guerbet

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeong Min Lee, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Guerbet Korea

Seoul, Gangnam Gu, South Korea

Countries

South Korea

Other Identifiers

DGD-44-057

Identifier Type: -

Identifier Source: org_study_id