Comparison of Biannual Ultrasonography and Annual Unenhanced Magnetic Resonance Imaging for HCC Surveillance

NCT ID: NCT02854241

Last Updated: 2021-03-17

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-01

Study Completion Date

2022-06-30

Brief Summary

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The purpose of this study is to investigate clinical feasibility of annual non-contrast magnetic resonance imaging for surveillance of hepatocellular carcinoma in high-risk group, in comparison with biannual ultrasonography.

Detailed Description

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The purpose of this study is to investigate clinical feasibility of annual non-contrast magnetic resonance imaging for surveillance of hepatocellular carcinoma in high-risk group, in comparison with biannual ultrasonography. In addition, the relationship between non-contrast MR parameters and clinical manifestation of liver function is investigated.

Conditions

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Cirrhosis Hepatocellular Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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LC group

LC group under surveillance of biannual ultrasonography and annual noncontrast liver MRI. Six month after the last MRI, contrast enhanced liver CT is performed to investigate presence of HCC.

Group Type EXPERIMENTAL

Biannual ultrasonography

Intervention Type PROCEDURE

Biannual ultrasonography for HCC surveillance, performed by board-certified radiologists.

Annual noncontrast liver MRI

Intervention Type PROCEDURE

Annual noncontrast liver MRI consisted of T2WI, precontrast T1WI, dual-echo image, DWI (single shot, multishot) and T2 map.

DWI using multishot and T2 map are not included for initial MR reading.

Contrast enhanced liver CT

Intervention Type PROCEDURE

In patients without report of HCC during surveillance period, contrast CT is performed 6 months after the last MR scan.

Interventions

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Biannual ultrasonography

Biannual ultrasonography for HCC surveillance, performed by board-certified radiologists.

Intervention Type PROCEDURE

Annual noncontrast liver MRI

Annual noncontrast liver MRI consisted of T2WI, precontrast T1WI, dual-echo image, DWI (single shot, multishot) and T2 map.

DWI using multishot and T2 map are not included for initial MR reading.

Intervention Type PROCEDURE

Contrast enhanced liver CT

In patients without report of HCC during surveillance period, contrast CT is performed 6 months after the last MR scan.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* equal to or older than 40 years
* under surveillance using biannual ultrasonography (USG) and presence of liver USG within 6 months (+/- 1month)
* risk index is equal to or higher than 2.33 (Risk Index = 1.65 (if the prothrombin activity is \<=75%) + 1.41 (if the age is 50 years or older) + 0.92 (if the platelet count is \<=100x10(3)/mm3) + 0.74 (if the presence of HCV or HBsAg is positive)).
* signed informed consent

Exclusion Criteria

* under 40 years
* history of HCC
* patients with pregnancy or nursing
* any contraindication of MRI
* any contraindication of CT
Minimum Eligible Age

40 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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Jeong Min Lee

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jeong Min Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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SNUH-2016-0174

Identifier Type: -

Identifier Source: org_study_id

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