Status:
TERMINATED
DCE-MRI Using Dotarem® in Evaluation of Therapeutic Response to Sorafenib in Patients With Advanced Stage HCC
Lead Sponsor:
Guerbet
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
20+ years
Phase:
PHASE4
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 wit...
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 (...
Eligibility Criteria
Inclusion
- Male and female adult patients (age ≥ 20 years old)
- Patients diagnosed with unresectable HCC \[Child Pugh class A and major vascular invasion, extrahapatic metastasis, or progression after transarterial chemoembolization more than 2 times\]
- Presence of mRECIST target lesion within liver \[lesion which can be classified as a RECIST measurable lesion (can be measured ≥ 1 cm in at least one dimension), lesion suitable for repeated measure, lesion showing intraluminal arterial enhancement on contrast-enhanced CT or MRI\]
- Patients planned to be treated with sorafenib
- Patient with liver CT performed or planned to be performed within 4 weeks before initiation of sorafenib treatment
- Patient with a life expectancy of 12 weeks or more
- No previous treatment with sorafenib
- 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
Exclusion
Key Trial Info
Start Date :
May 9 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 12 2015
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT01806740
Start Date
May 9 2013
End Date
October 12 2015
Last Update
August 8 2019
Active Locations (1)
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1
Guerbet Korea
Seoul, Gangnam Gu, South Korea, 135-920