Short-term MRI for Treatment Response Evaluation/Predicti... | NCT03731910

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

NCT03731910

Sponsor

Seoul National University Hospital

Status

Unknown status

Last Update Posted

Dec 17, 2021Actual

Enrollment

35Estimated

Phase

Not Applicable

Conditions

Hepatocellular Carcinoma

Interventions

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 11, 2018Actual

Primary Completion Date

Dec 31, 2022Estimated

Completion Date

Jun 30, 2023Estimated

First Submitted Date

Nov 4, 2018

First Submission Date that Met QC Criteria

Nov 4, 2018

First Posted Date

Nov 6, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 16, 2021

Last Update Posted Date

Dec 17, 2021Actual

Name	Class
Dongkook Lifesicence	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

35Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HCC group	Experimental	Participants who are scheduled for TARE for HCC treatment. They undergo MRI three times- before, 1- and 2-week after TARE.	Diagnostic Test: MRI

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MRI	Diagnostic Test	liver MRI using standard dose of extracellular agent. It includes dynamic contrast-enhanced MRI and diffusion weighted image.	HCC group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Tumor diffusion	measured with diffusion-weighted image sequence	1 months after last MRI
Tumor perfusion	measured with dynamic contrast-enhanced imaging

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hyun Hee Lee, RN	Contact	82-2-2072-4177		redlion55@naver.com
Jeong Hee Yoon, MD	Contact	82-2-2072-2584		cinamon1@snu.ac.kr

Overall Officials

Name	Affiliation	Role
Jeong Min Lee, MD	Seoul National University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital	Recruiting	Seoul			South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006528	Carcinoma, Hepatocellular

Ancestor Terms

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008279	Magnetic Resonance Imaging

Ancestor Terms

ID	Term
D014054	Tomography
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided