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

December 16, 2021 updated by: Jeong Min Lee, Seoul National University Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HCC group
Participants who are scheduled for TARE for HCC treatment. They undergo MRI three times- before, 1- and 2-week after TARE.
Diagnostic test: MRI
liver MRI using standard dose of extracellular agent. It includes dynamic contrast-enhanced MRI and diffusion weighted image.
Other Names:
  • magnetic resonance imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment response mRECIST
Time Frame: 1 month after last MRI
treatment response using mRECIST
1 month after last MRI

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Dongkook Lifesicence

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 11, 2018

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

June 30, 2023

Study Registration Dates

First Submitted

November 4, 2018

First Submitted That Met QC Criteria

November 4, 2018

First Posted (Actual)

November 6, 2018

Study Record Updates

Last Update Posted (Actual)

December 17, 2021

Last Update Submitted That Met QC Criteria

December 16, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNUH-1807-149-957

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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