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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.BC

Abstract

BACKGROUND

Biannual ultrasound (US)-with or without alpha-fetoprotein (AFP)-is recommended by current guidelines for the surveillance of hepatocellular carcinoma (HCC). However, the inadequate sensitivity of US has been a concern. Magnetic resonance imaging (MRI) is known to have high sensitivity in detecting hepatic malignancies, even without contrast enhancement. The purpose of our study is to compare US with noncontrast (unenhanced) MRI for HCC surveillance of high-risk patients.

METHODS/DESIGN

MIRACLE-HCC (usefulness of noncontrast MagnetIc Resonance imAging versus nonContrast ultrasonography for surveiLlancE of HepatoCellular Carcinoma) is a prospective, single-center, nonblinded, balanced-randomized, parallel-group study. This study was approved by our institutional review board, and informed consent will be obtained from all participating patients. All patients with compensated liver cirrhosis will undergo noncontrast US or MRI, with serum AFP testing every 6 months. If a suspicious lesion is newly detected, or if the serum AFP level is elevated in an increasing trend for two consecutive tests, dynamic contrast-enhanced imaging will be performed to confirm the diagnosis. The primary endpoints are detection rates of very early or early stage HCC, stage distribution at the initial diagnosis, and false positive referral rates, which will be compared using Fisher's exact or chi-square tests. The study will include 416 patients in a tertiary academic medical center in South Korea.

DISCUSSION

MIRACLE-HCC is the first prospective randomized trial to compare the effectiveness of noncontrast MRI and noncontrast US in the surveillance of HCC in at-risk patients. The results of this trial will show whether noncontrast MRI surveillance is superior to noncontrast US surveillance in the early detection of HCC. The trial will also determine whether there are fewer false referrals with noncontrast MRI than with noncontrast US and, eventually, whether there is improvement in the overall survival of HCC patients.

TRIAL REGISTRATION

The date of trial registration (ClincalTrials.gov: NCT02514434) for this study is July 23, 2015. Enrollment of participants was finished in November 2017. No authors have relationships, conditions, or circumstances that present potential conflicts of interest.

Authors+Show Affiliations

Department of Radiology, Research Institute of Radiological Science, Yonsei University College of Medicine, 50 Yonsei-ro, Seodaemun-gu, Seoul, 03722, South Korea.Department of Internal Medicine, Yonsei University College of Medicine, Seoul, South Korea.Department of Radiology, Research Institute of Radiological Science, Yonsei University College of Medicine, 50 Yonsei-ro, Seodaemun-gu, Seoul, 03722, South Korea.Department of Internal Medicine, Yonsei University College of Medicine, Seoul, South Korea.Biostatistics Collaboration Unit, Medical Research Center, Yonsei University College of Medicine, Seoul, South Korea.Department of Radiology, Research Institute of Radiological Science, Yonsei University College of Medicine, 50 Yonsei-ro, Seodaemun-gu, Seoul, 03722, South Korea. kimnex@yuhs.ac.

Pub Type(s)

Clinical Trial
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

30249190

Citation

An, Chansik, et al. "Noncontrast Magnetic Resonance Imaging Versus Ultrasonography for Hepatocellular Carcinoma Surveillance (MIRACLE-HCC): Study Protocol for a Prospective Randomized Trial." BMC Cancer, vol. 18, no. 1, 2018, p. 915.
An C, Kim DY, Choi JY, et al. Noncontrast magnetic resonance imaging versus ultrasonography for hepatocellular carcinoma surveillance (MIRACLE-HCC): study protocol for a prospective randomized trial. BMC Cancer. 2018;18(1):915.
An, C., Kim, D. Y., Choi, J. Y., Han, K. H., Roh, Y. H., & Kim, M. J. (2018). Noncontrast magnetic resonance imaging versus ultrasonography for hepatocellular carcinoma surveillance (MIRACLE-HCC): study protocol for a prospective randomized trial. BMC Cancer, 18(1), 915. https://doi.org/10.1186/s12885-018-4827-2
An C, et al. 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. PubMed PMID: 30249190.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Noncontrast magnetic resonance imaging versus ultrasonography for hepatocellular carcinoma surveillance (MIRACLE-HCC): study protocol for a prospective randomized trial. AU - An,Chansik, AU - Kim,Do Young, AU - Choi,Jin-Young, AU - Han,Kwang Hyub, AU - Roh,Yun Ho, AU - Kim,Myeong-Jin, Y1 - 2018/09/24/ PY - 2017/12/12/received PY - 2018/09/17/accepted PY - 2018/9/26/entrez PY - 2018/9/27/pubmed PY - 2018/12/12/medline KW - Hepatocellular carcinoma KW - Magnetic resonance imaging KW - Surveillance KW - Ultrasonography SP - 915 EP - 915 JF - BMC cancer JO - BMC Cancer VL - 18 IS - 1 N2 - BACKGROUND: Biannual ultrasound (US)-with or without alpha-fetoprotein (AFP)-is recommended by current guidelines for the surveillance of hepatocellular carcinoma (HCC). However, the inadequate sensitivity of US has been a concern. Magnetic resonance imaging (MRI) is known to have high sensitivity in detecting hepatic malignancies, even without contrast enhancement. The purpose of our study is to compare US with noncontrast (unenhanced) MRI for HCC surveillance of high-risk patients. METHODS/DESIGN: MIRACLE-HCC (usefulness of noncontrast MagnetIc Resonance imAging versus nonContrast ultrasonography for surveiLlancE of HepatoCellular Carcinoma) is a prospective, single-center, nonblinded, balanced-randomized, parallel-group study. This study was approved by our institutional review board, and informed consent will be obtained from all participating patients. All patients with compensated liver cirrhosis will undergo noncontrast US or MRI, with serum AFP testing every 6 months. If a suspicious lesion is newly detected, or if the serum AFP level is elevated in an increasing trend for two consecutive tests, dynamic contrast-enhanced imaging will be performed to confirm the diagnosis. The primary endpoints are detection rates of very early or early stage HCC, stage distribution at the initial diagnosis, and false positive referral rates, which will be compared using Fisher's exact or chi-square tests. The study will include 416 patients in a tertiary academic medical center in South Korea. DISCUSSION: MIRACLE-HCC is the first prospective randomized trial to compare the effectiveness of noncontrast MRI and noncontrast US in the surveillance of HCC in at-risk patients. The results of this trial will show whether noncontrast MRI surveillance is superior to noncontrast US surveillance in the early detection of HCC. The trial will also determine whether there are fewer false referrals with noncontrast MRI than with noncontrast US and, eventually, whether there is improvement in the overall survival of HCC patients. TRIAL REGISTRATION: The date of trial registration (ClincalTrials.gov: NCT02514434) for this study is July 23, 2015. Enrollment of participants was finished in November 2017. No authors have relationships, conditions, or circumstances that present potential conflicts of interest. SN - 1471-2407 UR - https://www.unboundmedicine.com/medline/citation/30249190/Noncontrast_magnetic_resonance_imaging_versus_ultrasonography_for_hepatocellular_carcinoma_surveillance__MIRACLE_HCC_:_study_protocol_for_a_prospective_randomized_trial_ L2 - https://bmccancer.biomedcentral.com/articles/10.1186/s12885-018-4827-2 DB - PRIME DP - Unbound Medicine ER -