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NCT03731910 Clinical Trial

Short-term MRI for Treatment Response Evaluation/Prediction of HCC Treated With TARE

Hepatocellular Carcinoma Clinical Trial

Official title:
Short Term Magnetic Resonance Imaging (MRI) for Treatment Response Evaluation and Prognosis Prediction in Patients With Hepatocellular Carcinoma (HCC) Treated With Transarterial Radioembolization (TARE)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03731910
Other study ID # SNUH-1807-149-957
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 11, 2018
Est. completion date June 30, 2023

Study information
Verified date December 2021
Source Seoul National University Hospital
Contact Hyun Hee Lee, RN
Phone 82-2-2072-4177
Email redlion55@naver.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims to investigate the value of early change at MRI in HCC treated with TARE, for evaluation/prediction of treatment response and prognosis.

Recruitment information / eligibility
Status Recruiting
Enrollment 35
Est. completion date June 30, 2023
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria: - Intermediate or locally advanced HCC according to Hong Kong Liver Cancer guideline - Scheduled for transarterial radioembolization (TARE) - sign informed consent Exclusion Criteria: - Any absolute or relative contra-indication of contrast-enhanced MRI - History of other local treatment before TARE in 3 weeks

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• MRI
liver MRI using standard dose of extracellular agent. It includes dynamic contrast-enhanced MRI and diffusion weighted image.

Locations
Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (2)
Lead Sponsor Collaborator
Seoul National University Hospital Dongkook Lifesicence

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Treatment response mRECIST treatment response using mRECIST 1 month after last MRI
Secondary Tumor diffusion measured with diffusion-weighted image sequence 1 months after last MRI
Secondary Tumor perfusion measured with dynamic contrast-enhanced imaging 1 months after last MRI
Secondary Treatment response LI-RADS treatment response using LI-RADSv 2018 treatment response category 1 months after last MRI
Secondary Treatment response volumetric treatment response using volumetric response criteria 1 months after last MRI
Secondary Time to Progression Time until to definite progression on follow-up images 24 months after TARE
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