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

February 6, 2023 updated by: Pankaj Gupta, Postgraduate Institute of Medical Education and Research, Chandigarh

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

380

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • India
    • Punjab
      • Chandigarh, Punjab, India, 160012
        • Recruiting
        • Post Graduate Institute of Medical education and Research
        • Contact:
          • Pankaj Gupta
          • Phone Number: 8194896927

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HCC detection rate of US vs AMRI in cirrhotic patients
Time Frame: 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
Day 7 from the time of enrolment till 12 month's scan

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
False referral rate
Time Frame: 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
Day 7 from the time of enrolment till 12 month's scan
Sensitivity, specificity of US vs AMRI
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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.
Day 7 from the time of enrolment till 12 month's scan

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Postgraduate Institute of Medical Education and Research, Chandigarh

Collaborators

Indian Council of Medical Research

Investigators

  • Principal Investigator: Pankaj Gupta, PGIMER, Chandigarh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 8, 2022

Primary Completion (ANTICIPATED)

February 7, 2025

Study Completion (ANTICIPATED)

February 7, 2025

Study Registration Dates

First Submitted

January 29, 2023

First Submitted That Met QC Criteria

February 6, 2023

First Posted (ACTUAL)

February 8, 2023

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

February 6, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10295 (CTEP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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