Utility of Abbreviated Magnetic Resonance Imaging as a Screening Tool for Hepatocellular Carcinoma in Cirrhotic Patients
Study Details
Study Description
Brief Summary
The goal of this study is Utility of abbrevational magnetic resonance imaging as a screening tool for hepatocellular carcinoma in cirrhotic patients.
The primary objective of the study is:
• HCC detection rate of US vs AMRI in cirrhotic patients
The secondary objective of the study are:
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False referral rate of US vs AMRI: false referral will be defined as lack of HCC on complete MRI despite a positive US or AMRI.
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Positive predictive value of US vs AMRI: The positive predictive value will be defined as the number of patients with true positive results in patients with positive US/AMRI.
Participants will be evaluated by two rounds of screening 6 months apart using paired US and non-enhanced AMRI.
Condition or Disease | Intervention/Treatment | Phase |
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Detailed Description
Hepatocellular carcinoma (HCC) is the fifth most common cancer and is the second leading cause of cancer related death. The most important risk factor is cirrhosis of any etiology, particularly chronic hepatitis b and hepatitis c virus infection. Curative treatment (resection, transplant, or ablation) can be offered to patients diagnosed with early HCC. As the disease remains asymptomatic, most HCCs are diagnosed at an intermediate to terminal stage. Screening is an effective strategy to diagnose early HCC. The current guidelines recommend bi-annual screening with ultrasound (US) with or without alpha- fetoprotein (AFP). The overall sensitivity for detection of HCC using US screening is 60% while it is only 22% for detection of very early and early HCC. This results in many patients having progression of HCC despite being on screening program. Although computed tomography (CT) is widely available, the cumulative radiation dose from multiple screening CT scans makes CT screening unsuitable. Magnetic resonance imaging (MRI) has a high sensitivity and specificity for diagnosis of HCC owing to its high contrast resolution. A recent study showed significantly better sensitivity of HCC detection during screening using contrast enhanced MRI (CE-MRI) as compared with US. The use of CE-MRI entails high cost and risk of nephrogenic systemic fibrosis and is not well suited for screening from the health economics standpoint. Recently abbreviated MRI (AMRI) has been proposed as an acceptable alternative to US for HCC screening. AMRI involves acquisition of only a few MRI sequences rather than the complete MRI. This results in lesser table time and in turn reduced cost. However, most of the data is from retrospective studies. We propose a prospective study to evaluate the role of AMRI for HCC screening.
Study Design
Outcome Measures
Primary Outcome Measures
- HCC detection rate of US vs AMRI in cirrhotic patients [Day 7 from the time of enrolment till 12 month's scan]
number of HCCs detected by US / AMRI divided by the actual number of HCCs based reference standard
Secondary Outcome Measures
- False referral rate [Day 7 from the time of enrolment till 12 month's scan]
number of false positive results divided by the sum of true negative and false- positive results
- Sensitivity, specificity of US vs AMRI [Day 7 from the time of enrolment till 12 month's scan]
Sensitivity, specificity of US vs AMRI
- positive predictive value of US vs AMRI [Day 7 from the time of enrolment till 12 month's scan]
positive predictive value of US vs AMRI
- negative predictive value of US vs AMRI [Day 7 from the time of enrolment till 12 month's scan]
negative predictive value of US vs AMRI
- Survival of patients [Day 7 from the time of enrolment till 12 month's scan]
Patients who develop HCC during the 1-year follow up period using Kaplan Meier survival analysis.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age>40 years
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Presence of cirrhosis
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Annual risk of HCC >5%
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No HCC on pre-enrollment imaging not more than 6 months back.
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Risk factors including diabetes mellitus, metabolic syndrome, family history of HCC.
Exclusion Criteria:
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Child C status
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Diagnosed or follow up case of HCC
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Other malignancies
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Pregnancy, lactation
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Contraindications to MRI (pacemaker, cochlear implant, claustrophobia)
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Chronic renal disease or contrast allergy precluding administration of intravenous MRI contrast agent (for reference standard)
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Post Graduate Institute of Medical Education and Research | Chandigarh | Punjab | India | 160012 |
Sponsors and Collaborators
- Postgraduate Institute of Medical Education and Research, Chandigarh
- Indian Council of Medical Research
Investigators
- Principal Investigator: Pankaj Gupta, PGIMER, CHANDIGARH
Study Documents (Full-Text)
None provided.More Information
Publications
- Center MM, Jemal A. International trends in liver cancer incidence rates. Cancer Epidemiol Biomarkers Prev. 2011 Nov;20(11):2362-8. doi: 10.1158/1055-9965.EPI-11-0643. Epub 2011 Sep 15.
- Kalra N, Gupta P, Chawla Y, Khandelwal N. Locoregional treatment for hepatocellular carcinoma: The best is yet to come. World J Radiol. 2015 Oct 28;7(10):306-18. doi: 10.4329/wjr.v7.i10.306.
- Kanwal F, Singal AG. Surveillance for Hepatocellular Carcinoma: Current Best Practice and Future Direction. Gastroenterology. 2019 Jul;157(1):54-64. doi: 10.1053/j.gastro.2019.02.049. Epub 2019 Apr 12.
- Kim YK, Kim YK, Park HJ, Park MJ, Lee WJ, Choi D. Noncontrast MRI with diffusion-weighted imaging as the sole imaging modality for detecting liver malignancy in patients with high risk for hepatocellular carcinoma. Magn Reson Imaging. 2014 Jul;32(6):610-8. doi: 10.1016/j.mri.2013.12.021. Epub 2014 Jan 13.
- Mazhar SM, Shiehmorteza M, Kohl CA, Middleton MS, Sirlin CB. Nephrogenic systemic fibrosis in liver disease: a systematic review. J Magn Reson Imaging. 2009 Dec;30(6):1313-22. doi: 10.1002/jmri.21983.
- Nakamoto A, Yamamoto K, Sakane M, Nakai G, Higashiyama A, Juri H, Yoshikawa S, Narumi Y. Reduction of the radiation dose and the amount of contrast material in hepatic dynamic CT using low tube voltage and adaptive iterative dose reduction 3-dimensional. Medicine (Baltimore). 2018 Aug;97(34):e11857. doi: 10.1097/MD.0000000000011857.
- Roayaie S, Obeidat K, Sposito C, Mariani L, Bhoori S, Pellegrinelli A, Labow D, Llovet JM, Schwartz M, Mazzaferro V. Resection of hepatocellular cancer </=2 cm: results from two Western centers. Hepatology. 2013 Apr;57(4):1426-35. doi: 10.1002/hep.25832. Epub 2013 Jan 25.
- Singal A, Volk ML, Waljee A, Salgia R, Higgins P, Rogers MA, Marrero JA. Meta-analysis: surveillance with ultrasound for early-stage hepatocellular carcinoma in patients with cirrhosis. Aliment Pharmacol Ther. 2009 Jul;30(1):37-47. doi: 10.1111/j.1365-2036.2009.04014.x. Epub 2009 Apr 8.
- Tzartzeva K, Obi J, Rich NE, Parikh ND, Marrero JA, Yopp A, Waljee AK, Singal AG. Surveillance Imaging and Alpha Fetoprotein for Early Detection of Hepatocellular Carcinoma in Patients With Cirrhosis: A Meta-analysis. Gastroenterology. 2018 May;154(6):1706-1718.e1. doi: 10.1053/j.gastro.2018.01.064. Epub 2018 Feb 6.
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