Noninvasive Staging of Liver Fibrosis: MR vs Ultrasound

NCT02044523 | Completed

• 1 other identifier: CE12.062
• Study Type: observational
• Target: 108
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

Chronic liver disease; Fibrosis; Elastography; Ultrasound; Magnetic resonance elastography; Diagnostic performance; Sensitivity and specificity

Outcome Measures

Primary Outcomes (1)

• Histology-determined fibrosis stage

  Within 6 weeks of elastographic methods

Secondary Outcomes (5)

• Fibroscan-determined liver stiffness

  Within 6 weeks of liver biopsy

• Acoustic Radiation Force Impulse (ARFI)-determined liver stiffness

  Within 6 weeks of liver biopsy

• Magnetic Resonance Elastography (MRE)-determined liver stiffness

  Within 6 weeks of liver biopsy

• Magnetic Resonance Imaging (MRI)-based Proton Density Fat Fraction (PDFF)

  Within 6 weeks of liver biopsy

• Magnetic Resonance Imaging (MRI) cine-tagging of cardiac-induced motion for staging liver fibrosis

  Within 6 weeks of liver biopsy

Study Arms (1)

Hepatis C, Hepatitis B, NAFLD

All patients enrolled will undergo: * Transient Elastography (Fibroscan) * Acoustic Radiation Force Impulse (ARFI) * Magnetic Resonance Elastography (MRE)

Device: Transient elastography, acoustic radiation force impulse, magnetic resonance elastography

Interventions

Transient elastography, acoustic radiation force impulse, magnetic resonance elastography DEVICE

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

Also known as: Transient elastography (Fibroscan), Acoustic Radiation Force Impulse (ARFI), Magnetic Resonance Elastography (MRE)

Hepatis C, Hepatitis B, NAFLD

Eligibility Criteria

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

Study Population

The target population is adults with any of the three main causes of liver fibrosis: HBV, HCV or NASH. For the purpose of this study, we will recruit patients seen at the hepatology clinic of St-Luc Hospital, a tertiary care center.

You may qualify if:

• are adults;
• must undergo a liver biopsy as part of their clinical standard of care for suspected or known chronic liver disease caused by HBV, HCV or NASH;
• understand French or English instruction;
• Autoimmune Hepatitis

You may not qualify if:

• have any contra-indication to MRI (such as claustrophobia, pacemaker, metallic clips for a neurosurgical procedure);
• are pregnant or trying to become pregnant;
• have a weight or girth preventing them from entering the MR magnet bore;
• are unable to understand or unwilling to provide written informed consent for this study.

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Centre de Recherche du Centre Hospitalier de l'Université de Montréal: collaborator

Study Sites (1)

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, H2X 0A9, Canada

Location

Related Publications (1)

• Lefebvre T, Wartelle-Bladou C, Wong P, Sebastiani G, Giard JM, Castel H, Murphy-Lavallee J, Olivie D, Ilinca A, Sylvestre MP, Gilbert G, Gao ZH, Nguyen BN, Cloutier G, Tang A. Prospective comparison of transient, point shear wave, and magnetic resonance elastography for staging liver fibrosis. Eur Radiol. 2019 Dec;29(12):6477-6488. doi: 10.1007/s00330-019-06331-4. Epub 2019 Jul 5.

  PMID: 31278577 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Liver biopsy specimens.

MeSH Terms

Conditions

Hepatitis C; Hepatitis B; Non-alcoholic Fatty Liver Disease; Fibrosis; Hypersensitivity

Interventions

Elasticity Imaging Techniques

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Hepadnaviridae Infections; DNA Virus Infections; Fatty Liver; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Immune System Diseases

Intervention Hierarchy (Ancestors)

Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• An Tang, MD, MSc

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2014
• First Posted: January 24, 2014
• Study Start: January 1, 2014
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: September 20, 2018

Record last verified: 2017-07

Locations

CA (1)