Short-term MRI for Treatment Response Evaluation/Prediction of HCC Treated With TARE
Short Term Magnetic Resonance Imaging (MRI) for Treatment Response Evaluation and Prognosis Prediction in Patients With Hepatocellular Carcinoma (HCC) Treated With Transarterial Radioembolization (TARE)
1 other identifier
interventional
35
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable hepatocellular-carcinoma
Started Dec 2018
Typical duration for not_applicable hepatocellular-carcinoma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 4, 2018
CompletedFirst Posted
Study publicly available on registry
November 6, 2018
CompletedStudy Start
First participant enrolled
December 11, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2023
CompletedDecember 17, 2021
December 1, 2021
4.1 years
November 4, 2018
December 16, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Treatment response mRECIST
treatment response using mRECIST
1 month after last MRI
Secondary Outcomes (5)
Tumor diffusion
1 months after last MRI
Tumor perfusion
1 months after last MRI
Treatment response LI-RADS
1 months after last MRI
Treatment response volumetric
1 months after last MRI
Time to Progression
24 months after TARE
Study Arms (1)
HCC group
EXPERIMENTALParticipants who are scheduled for TARE for HCC treatment. They undergo MRI three times- before, 1- and 2-week after TARE.
Interventions
liver MRI using standard dose of extracellular agent. It includes dynamic contrast-enhanced MRI and diffusion weighted image.
Eligibility Criteria
You may qualify if:
- Intermediate or locally advanced HCC according to Hong Kong Liver Cancer guideline
- Scheduled for transarterial radioembolization (TARE)
- sign informed consent
You may not qualify if:
- Any absolute or relative contra-indication of contrast-enhanced MRI
- History of other local treatment before TARE in 3 weeks
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seoul National University Hospitallead
- Dongkook Lifesicencecollaborator
Study Sites (1)
Seoul National University Hospital
Seoul, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeong Min Lee, MD
Seoul National University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 4, 2018
First Posted
November 6, 2018
Study Start
December 11, 2018
Primary Completion
December 31, 2022
Study Completion
June 30, 2023
Last Updated
December 17, 2021
Record last verified: 2021-12
Data Sharing
- IPD Sharing
- Will not share