NCT02514434

Brief Summary

The investigators will investigate the usefulness of ultrasonography versus non-contrast magnetic resonance imaging for surveillance of hepatocellular carcinoma through this prospective, randomized trial.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
416

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 30, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 3, 2015

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

March 21, 2019

Status Verified

March 1, 2019

Enrollment Period

7.7 years

First QC Date

July 23, 2015

Last Update Submit

March 20, 2019

Conditions

Compensated Liver Cirrhosis

Outcome Measures

Primary Outcomes (2)

  • Tumor stage of HCC

    Comparing tumor stage and resectability rate of HCC between participants undergoing HCC surveillance using ultrasonography and non-contrast MRI.

    6 months

  • Resectability rate of HCC

    Comparing tumor stage and resectability rate of HCC between participants undergoing HCC surveillance using ultrasonography and non-contrast MRI.

    6 months

Secondary Outcomes (3)

  • Five-year overall survival

    5 years after the study enrollment

  • Liver-related mortality

    5 years after the study enrollment

  • Post-treatment recurrence rate

    5 years after the study enrollment

Study Arms (2)

Ultrasonography

EXPERIMENTAL

Subjects will be regularly screened for HCC by ultrasonography with serum AFP(alpha fetoprotein).

Radiation: Ultrasonography

Non-contrast MRI

EXPERIMENTAL

Subjects will be regularly screened for HCC by non-contrast magnetic resonance imaging(MRI) with serum AFP(alpha fetoprotein).

Radiation: non-contrast MRI

Interventions

UltrasonographyRADIATION

Subjects will be randomly allocated to either Ultrasonography arm or Non-contrast MRI arm for their surveillance method.

Ultrasonography
non-contrast MRIRADIATION

Subjects will be randomly allocated to either Ultrasonography arm or Non-contrast MRI arm for their surveillance method.

Non-contrast MRI

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female subject between 20 and 70 years of age at the time of randomization
  • Has chronic liver disease with compensated liver cirrhosis (Child-Pugh score A), defined as 1) histologically confirmed cirrhosis, or 2) has chronic liver disease and shows the presence of splenomegaly or other typical findings of liver cirrhosis on ultrasonography, computed tomography, or magnetic resonance imaging, or 3) has chronic liver disease and shows the presence of endoscopically-confirmed esophageal or gastric varices
  • Absence of severe cardiovascular, pulmonary, renal or infectious diseases, other than chronic liver disease
  • Absence of a history of malignancy within previous 5 years
  • Can and will comply with the requirements of the protocol (e.g. return for follow-up visits), in the opinion of the investigator
  • Has provided written informed consent

You may not qualify if:

  • Greater than 70 years of age
  • Presence of liver cancer or other intrahepatic malignancy
  • Has a history of malignancy within previous 5 years
  • Is pregnant or breast-feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Gastroenterology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine

Seoul, 120-752, South Korea

Location

Related Publications (2)

  • Rhee H, Kim MJ, Kim DY, An C, Kang W, Han K, Roh YH, Han KH, Ahn SH, Choi JY, Park JY, Chung YE, Kim SU, Kim BK, Lee S, Lee HW, Lee JS. Noncontrast Magnetic Resonance Imaging vs Ultrasonography for Hepatocellular Carcinoma Surveillance: A Randomized, Single-Center Trial. Gastroenterology. 2025 Jun;168(6):1170-1177.e12. doi: 10.1053/j.gastro.2024.12.035. Epub 2025 Jan 22.

    PMID: 39855314DERIVED

  • An C, Kim DY, Choi JY, Han KH, Roh YH, Kim MJ. Noncontrast magnetic resonance imaging versus ultrasonography for hepatocellular carcinoma surveillance (MIRACLE-HCC): study protocol for a prospective randomized trial. BMC Cancer. 2018 Sep 24;18(1):915. doi: 10.1186/s12885-018-4827-2.

    PMID: 30249190DERIVED

MeSH Terms

Interventions

High-Energy Shock Waves

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2015

First Posted

August 3, 2015

Study Start

March 30, 2015

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

March 21, 2019

Record last verified: 2019-03

Locations

KR(1)