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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05716620
• Other study ID #: 10295
• Status: Recruiting
• Start date: February 8, 2022
• Est. completion date: February 7, 2025

Study information

• Verified date: January 2023
• Source: Postgraduate Institute of Medical Education and Research, Chandigarh
• Contact: PANKAJ GUPTA
• Phone: 8194896927
• Email: pankajgupta959[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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:

• 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 380
• Est. completion date: February 7, 2025
• Est. primary completion date: February 7, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Age>40 years

2. Presence of cirrhosis

3. Annual risk of HCC >5%

4. No HCC on pre-enrollment imaging not more than 6 months back.

5. Risk factors including diabetes mellitus, metabolic syndrome, family history of HCC.

Exclusion Criteria:

1. Child C status

2. Diagnosed or follow up case of HCC

3. Other malignancies

4. Pregnancy, lactation

5. Contraindications to MRI (pacemaker, cochlear implant, claustrophobia)

6. Chronic renal disease or contrast allergy precluding administration of intravenous MRI contrast agent (for reference standard)

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

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.

Locations

Country	Name	City	State
India	Post Graduate Institute of Medical Education and Research	Chandigarh	Punjab

Sponsors (2)

Lead Sponsor	Collaborator
Postgraduate Institute of Medical Education and Research, Chandigarh	Indian Council of Medical Research

Country where clinical trial is conducted

India, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Sensitivity, specificity of US vs AMRI	Sensitivity, specificity of US vs AMRI	Day 7 from the time of enrolment till 12 month's scan
Secondary	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
Secondary	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
Secondary	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