Back to resultsShort-term MRI for Treatment Response Evaluation/Prediction of HCC Treated With TARE
Primary Purpose
Hepatocellular Carcinoma
Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
MRI
Sponsored by
About this trial
This is an interventional other trial for Hepatocellular Carcinoma focused on measuring MRI
Eligibility Criteria
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
Sites / Locations
- Seoul National University HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HCC group
Arm Description
Participants who are scheduled for TARE for HCC treatment. They undergo MRI three times- before, 1- and 2-week after TARE.
Outcomes
Primary Outcome Measures
Treatment response mRECIST
treatment response using mRECIST
Secondary Outcome Measures
Tumor diffusion
measured with diffusion-weighted image sequence
Tumor perfusion
measured with dynamic contrast-enhanced imaging
Treatment response LI-RADS
treatment response using LI-RADSv 2018 treatment response category
Treatment response volumetric
treatment response using volumetric response criteria
Time to Progression
Time until to definite progression on follow-up images
Full Information
NCT ID
NCT03731910
First Posted
November 4, 2018
Last Updated
December 16, 2021
Sponsor
Seoul National University Hospital
Collaborators
Dongkook Lifesicence
1. Study Identification
Unique Protocol Identification Number
NCT03731910
Brief Title
Short-term MRI for Treatment Response Evaluation/Prediction of HCC Treated With TARE
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)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
December 11, 2018 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Dongkook Lifesicence
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
MRI
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HCC group
Arm Type
Experimental
Arm Description
Participants who are scheduled for TARE for HCC treatment. They undergo MRI three times- before, 1- and 2-week after TARE.
Intervention Type
Diagnostic Test
Intervention Name(s)
MRI
Other Intervention Name(s)
magnetic resonance imaging
Intervention Description
liver MRI using standard dose of extracellular agent. It includes dynamic contrast-enhanced MRI and diffusion weighted image.
Primary Outcome Measure Information:
Title
Treatment response mRECIST
Description
treatment response using mRECIST
Time Frame
1 month after last MRI
Secondary Outcome Measure Information:
Title
Tumor diffusion
Description
measured with diffusion-weighted image sequence
Time Frame
1 months after last MRI
Title
Tumor perfusion
Description
measured with dynamic contrast-enhanced imaging
Time Frame
1 months after last MRI
Title
Treatment response LI-RADS
Description
treatment response using LI-RADSv 2018 treatment response category
Time Frame
1 months after last MRI
Title
Treatment response volumetric
Description
treatment response using volumetric response criteria
Time Frame
1 months after last MRI
Title
Time to Progression
Description
Time until to definite progression on follow-up images
Time Frame
24 months after TARE
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hyun Hee Lee, RN
Phone
82-2-2072-4177
Email
redlion55@naver.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jeong Hee Yoon, MD
Phone
82-2-2072-2584
Email
cinamon1@snu.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeong Min Lee, MD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyun Hee Lee, RN
Phone
82-2-2072-4177
Email
redlion55@naver.com
First Name & Middle Initial & Last Name & Degree
Jeong Hee Yoon, MD
Phone
82-2-2072-2584
Email
cinamon1@snu.ac.kr
First Name & Middle Initial & Last Name & Degree
Jeong Min Lee, MD, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Short-term MRI for Treatment Response Evaluation/Prediction of HCC Treated With TARE
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