Non-contrast Abbreviated MRI for Secondary Surveillance of HCC

NCT ID: NCT05690451

Last Updated: 2024-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

210 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-28

Study Completion Date

2024-06-22

Brief Summary

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This prospective multicenter study aimed to compare the diagnostic performance of non-contrast abbreviated MRI in detecting recurrent HCC after curative treatment to that of contrast-enhanced liver CT.

Detailed Description

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This study was designed as a prospective single-arm intra-individual comparison multicenter study

Conditions

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Hepatocellular Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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non-contrast abbreviated MRI

Liver MRI without contrast injection. The following sequences will be obtained from all of the participants.

* Axial heavily and regular T2 WI
* precontrast fat-suppressed T1 WI
* Diffusion-weighted image using b-value of 0, 50 or 400, and 800 or 1000

Intervention Type DIAGNOSTIC_TEST

Contrast enhanced liver CT

Liver CT with iodine contrast injection This test will be served as a standard diagnostic test. The following phases will be obtained

* precontast, arterial phase, portal venous phase and delayed phase

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Age between 20-year old and 85-year old
* Patients with a history of curative treatment for HCC including surgical resection or local ablation
* No recurrence after curative treatment of HCC for more than two years
* Patient who has the plan to perform contrast-enhanced liver CT for secondary surveillance for HCC (i.e., to detect de novo or recurrent HCC)

Exclusion Criteria

* Estimated GFR less than 60
* Previous history of severe allergic reaction to the iodinated contrast agent
* Patients with claustrophobia who can't undergo MR examination
* Patients having cochlear implants or cardiac pacemaker
Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dong Ho Lee

Clinical professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dong Ho Lee, M.D.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Bundang Hospital

Seongnam, Korea (the Republic Of), South Korea

Site Status

Asan Medical Center

Seoul, Korea (the Republic Of), South Korea

Site Status

Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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KCT0006395

Identifier Type: REGISTRY

Identifier Source: secondary_id

H-2106-183-1230

Identifier Type: -

Identifier Source: org_study_id

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