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

NCT05716620 | Unknown

• 1 other identifier: 10295
• Study Type: observational
• Target: 380
• Locations: 1 country
• Sites: 1

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:
• 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.

Conditions

Hepatocellular Carcinoma

Keywords

HCC, cirrhosis, chronic liver disease, hepatitis B & C

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• False referral rate

  Day 7 from the time of enrolment till 12 month's scan

• 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

  Day 7 from the time of enrolment till 12 month's scan

• negative predictive value of US vs AMRI

  Day 7 from the time of enrolment till 12 month's scan

• Survival of patients

  Day 7 from the time of enrolment till 12 month's scan

Interventions

MRI DIAGNOSTIC_TEST

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.

Also known as: USG

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients will be evaluated by two rounds of screening 6 months apart using paired US and non- enhanced AMRI. First round of screening will be performed within 6 months of a negative imaging prior to recruitment in patients who fulfill the inclusion and exclusion criteria discussed above. US and AMRI will be performed on the same day. US will be performed prior to MRI. US \& AMRI will be performed by the two radiologists independently. Fasting status will not be mandatory.Radiologists will be blinded to clinical details including the risk of HCC, tumor markers and to the results of other imaging tests.

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead
• Indian Council of Medical Research: collaborator

Study Sites (1)

Post Graduate Institute of Medical Education and Research

Chandigarh, Punjab, 160012, India

RECRUITING

Related 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.

  PMID: 21921256 BACKGROUND

• 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.

  PMID: 26516427 BACKGROUND

• 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.

  PMID: 22576353 BACKGROUND

• 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.

  PMID: 30986389 BACKGROUND

• 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.

  PMID: 19392863 BACKGROUND

• 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.

  PMID: 29425931 BACKGROUND

• 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.

  PMID: 24702980 BACKGROUND

• 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.

  PMID: 30142778 BACKGROUND

• 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.

  PMID: 19937937 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Fibrosis; Hepatitis B

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis

Study Officials

• Pankaj Gupta

  PGIMER, CHANDIGARH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

PANKAJ GUPTA

CONTACT

8194896927; pankajgupta959@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 29, 2023
• First Posted: February 8, 2023
• Study Start: February 8, 2022
• Primary Completion: February 7, 2025
• Study Completion: February 7, 2025
• Last Updated: February 8, 2023

Record last verified: 2023-01

Locations

IN (1)