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

• Status: Terminated
• Trial end date: 2015-10-12
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Guerbet
• Treatments: Gadolinium 1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetate; Sorafenib

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