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Trial record 1 of 1 for:    MIRACLE-HCC
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Usefulness of Non-contrast MagnetIc Resonance imAging Versus Non-Contrast Ultrasonography for surveiLlancE of HepatoCellular Carcinoma [MIRACLE-HCC]

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02514434
Recruitment Status : Active, not recruiting
First Posted : August 3, 2015
Last Update Posted : March 21, 2019
Sponsor:
Information provided by (Responsible Party):
Yonsei University

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.

Condition or disease Intervention/treatment Phase
Compensated Liver Cirrhosis Radiation: Ultrasonography Radiation: non-contrast MRI Not Applicable

Detailed Description:

Hepatocellular carcinoma (HCC) is one of the major complications in patients with chronic liver disease. The prognosis of HCC relies on the extent of disease at the time of diagnosis. Hence to detect cancer at an earlier stage, a regular surveillance test is important for the subjects with a high risk of developing cancer. Current guidelines recommend a regular surveillance using ultrasonography at a 6 month-interval. Ultrasonography is a non-invasive and safe procedure, yet it is limited by the skills of the operator and it is often difficult to differentiate cancer from regenerating nodules especially in atrophied cirrhotic liver. According to a recent meta-analysis, the overall sensitivity and specificity of detecting liver cancer using ultrasonography were both over 90%, however the sensitivity was decreased to 60% in detecting early lesions in which surgery or liver transplantation is indicated. Of note, addition of AFP to ultrasonography also failed to increase the sensitivity in detecting small cancers. Taken together, there is a need to develop a new surveillance test with an improved sensitivity and specificity.

Recently, a retrospective study reported that CT or MRI showed a better sensitivity than ultrasonography in detecting early liver cancer. However, performing CT as a surveillance test is limited by frequent exposure to radiation and contrast-dye agent. Although MRI does not have the risk of radiation-exposure, it is limited by the high cost. On the contrast, non-contrast MRI offers a cost that is comparable to US and an absence of exposure to radiation or contrast-dye agent, which suggests non-contrast MRI as a good alternative surveillance tool for early detection of HCC. Therefore, in this prospective, randomized trial, the investigators will investigate the usefulness of ultrasonography versus non-contrast magnetic resonance imaging for surveillance of hepatocellular carcinoma.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 416 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Usefulness of Non-contrast MagnetIc Resonance imAging Versus Non-Contrast Ultrasonography for surveiLlancE of HepatoCellular Carcinoma [MIRACLE-HCC]
Actual Study Start Date : March 30, 2015
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ultrasonography
Subjects will be regularly screened for HCC by ultrasonography with serum AFP(alpha fetoprotein).
Radiation: Ultrasonography
Subjects will be randomly allocated to either Ultrasonography arm or Non-contrast MRI arm for their surveillance method.

Experimental: Non-contrast MRI
Subjects will be regularly screened for HCC by non-contrast magnetic resonance imaging(MRI) with serum AFP(alpha fetoprotein).
Radiation: non-contrast MRI
Subjects will be randomly allocated to either Ultrasonography arm or Non-contrast MRI arm for their surveillance method.




Primary Outcome Measures :
  1. Tumor stage of HCC [ Time Frame: 6 months ]
    Comparing tumor stage and resectability rate of HCC between participants undergoing HCC surveillance using ultrasonography and non-contrast MRI.

  2. Resectability rate of HCC [ Time Frame: 6 months ]
    Comparing tumor stage and resectability rate of HCC between participants undergoing HCC surveillance using ultrasonography and non-contrast MRI.


Secondary Outcome Measures :
  1. Five-year overall survival [ Time Frame: 5 years after the study enrollment ]
  2. Liver-related mortality [ Time Frame: 5 years after the study enrollment ]
  3. Post-treatment recurrence rate [ Time Frame: 5 years after the study enrollment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02514434


Locations
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Korea, Republic of
Institute of Gastroenterology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02514434    
Other Study ID Numbers: 4-2015-0029
First Posted: August 3, 2015    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019
Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Liver Cirrhosis
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases