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

Sponsor
Postgraduate Institute of Medical Education and Research, Chandigarh (Other)
Overall Status
Recruiting
CT.gov ID
NCT05716620
Collaborator
Indian Council of Medical Research (Other)
380
1
36
10.6

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:
  • 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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: MRI

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

Study Type:
Observational
Anticipated Enrollment :
380 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Utility of Abbreviated Magnetic Resonance Imaging as a Screening Tool for Hepatocellular Carcinoma in Cirrhotic Patients
Actual Study Start Date :
Feb 8, 2022
Anticipated Primary Completion Date :
Feb 7, 2025
Anticipated Study Completion Date :
Feb 7, 2025

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

  2. Sensitivity, specificity of US vs AMRI [Day 7 from the time of enrolment till 12 month's scan]

    Sensitivity, specificity of US vs AMRI

  3. 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

  4. 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

  5. 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

Ages Eligible for Study:
40 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
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

Responsible Party:
Pankaj Gupta, Associate Professor, Postgraduate Institute of Medical Education and Research, Chandigarh
ClinicalTrials.gov Identifier:
NCT05716620
Other Study ID Numbers:
  • 10295
First Posted:
Feb 8, 2023
Last Update Posted:
Feb 8, 2023
Last Verified:
Jan 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Pankaj Gupta, Associate Professor, Postgraduate Institute of Medical Education and Research, Chandigarh
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 8, 2023