Clinical trial NCT01806740: DCE-MRI Using Dotarem® in Evaluation of Therapeutic Response to Sorafenib in Patients With Advanced Stage HCC
Official title: Phase IV Study of DCE-MRI Using Dotarem® in Evaluation of Therapeutic Response to Sorafenib in Patients With Advanced Stage HCC
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Hepatocellular Carcinoma
Keywords: DCE-MRI
Sorafenib response
Lead sponsor: Guerbet
Sponsor class: INDUSTRY
First posted: 2013-03-07
Enrollment: 37
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility 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

Primary outcomes:
measure: Correlation Coefficient Between DCE-MRI Perfusion Parameters and the Response of Target Lesions to Sorafenib
timeFrame: 3 months
Secondary outcomes:
measure: Correlation Coefficient Between DCE-MRI Perfusion Parameters at Baseline and Overall Survival
timeFrame: 1 year
measure: Correlation Coefficient Between DCE-MRI Perfusion Parameters at Baseline and Progression Free Survival
timeFrame: 1 year
measure: Correlation Coefficient Between DCE-MRI Perfusion Parameters at Baseline and Time to Progression
timeFrame: 1 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Guerbet Korea
state: Gangnam Gu
Study officials:
affiliation: Seoul National University Hospital
name: Jeong Min Lee, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: