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Noninvasive Staging of Liver Fibrosis: MR vs Ultrasound

NCT02044523 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 108

Last updated 2018-09-20

No results posted yet for this study

Summary

Liver fibrosis is an important public health problem, with a substantial morbidity and mortality due to progression to cirrhosis and hepatocellular carcinoma. All causes of chronic liver disease may lead to fibrosis. The traditional diagnostic approach requires a biopsy for assessing the severity of liver disease prior to therapy.

However, liver biopsy has several limitations: cost, sampling error, and procedure-related morbidity and mortality. Considering the high prevalence of viral hepatitis and nonalcoholic fatty liver disease, a condition often associated with obesity and type 2 diabetes, there is an urgent need for noninvasive screening, diagnosis and monitoring strategies of chronic liver disease severity.

Our team has the expertise to investigate ultrasound-based and magnetic resonance-based elastographic methods for the noninvasive staging of liver fibrosis.

The primary objective of this cross-sectional study is to compare the sensitivity of elastographic methods for detecting histology-determined significant fibrosis.

The secondary objectives are to compare the diagnostic accuracy of these elastographic methods and the influence of potential confounders (inflammation, steatosis and iron deposition) on their diagnostic accuracy.

Conditions

  • Hepatitis C
  • Hepatitis B
  • Nonalcoholic Fatty Liver Disease (NAFLD)
  • Nonalcoholic Steatohepatitis (NASH)

Interventions

DEVICE

Transient elastography, acoustic radiation force impulse, magnetic resonance elastography

Transient elastography (Fibroscan) Acoustic Radiation Force Impulse (ARFI) Magnetic Resonance Elastography (MRE)

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • Centre de Recherche du Centre Hospitalier de l'Université de Montréal

    collaborator OTHER

  • Centre hospitalier de l'Université de Montréal (CHUM)

    lead OTHER

Principal Investigators

  • An Tang, MD, MSc · Centre hospitalier de l'Université de Montréal (CHUM)

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2018-06-30
Completion
2018-06-30

Countries

  • Canada

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02044523 on ClinicalTrials.gov