Utility of Abbreviated Magnetic Resonance Imaging as a Screening Tool for Hepatocellular Carcinoma in Cirrhotic Patients

Study Overview
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Brief Summary
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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: 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. 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.

Detailed Description
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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.

Official Title
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Utility of Abbreviated Magnetic Resonance Imaging as a Screening Tool for Hepatocellular Carcinoma in Cirrhotic Patients

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Diagnostic Test: MRI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age>40 years Presence of cirrhosis Annual risk of HCC >5% No HCC on pre-enrollment imaging not more than 6 months back. Risk factors including diabetes mellitus, metabolic syndrome, family history of HCC. Exclusion Criteria: Child C status Diagnosed or follow up case of HCC Other malignancies Pregnancy, lactation Contraindications to MRI (pacemaker, cochlear implant, claustrophobia) Chronic renal disease or contrast allergy precluding administration of intravenous MRI contrast agent (for reference standard)

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: MRI|USG and MRI will be performed on the same day. US will be performed prior to MRI. There will be two rounds of screening 6 months apart using paired US and non-enhanced AMRI.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HCC detection rate of US vs AMRI in cirrhotic patients | number of HCCs detected by US / AMRI divided by the actual number of HCCs based reference standard | Day 7 from the time of enrolment till 12 month's scan | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| False referral rate | number of false positive results divided by the sum of true negative and false- positive results | Day 7 from the time of enrolment till 12 month's scan | 
| Sensitivity, specificity of US vs AMRI | Sensitivity, specificity of US vs AMRI | Day 7 from the time of enrolment till 12 month's scan | 
| positive predictive value of US vs AMRI | positive 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 | negative predictive value of US vs AMRI | Day 7 from the time of enrolment till 12 month's scan | 
| Survival of patients | Patients who develop HCC during the 1-year follow up period using Kaplan Meier survival analysis. | Day 7 from the time of enrolment till 12 month's scan | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HCC, cirrhosis, chronic liver disease, hepatitis B & C