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Quantitative Ultrasound Techniques for Diagnosis of Nonalcoholic Steatohepatitis

Study acronym: QUS in NASH
StatusRecruiting
PhaseNot specified
Started2019-10-23
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 8 months later Feb 28, 2026 → Oct 31, 2026
See other at-risk trials from Centre hospitalier de l'Université de Montréal (CHUM)

Amendment history

2026-09-17
critical
Primary completion pushed: 2026-02-28 → 2026-10-31
Completion pushed: 2026-02-28 → 2027-02-28
2025-03-14
minor
Study Status, Eligibility v6
Primary completion date2024-10-30→2026-02-28
Completion date2024-10-30→2026-02-28
Eligibility criteria-24 characters
[...] to comprehend and willingness to provide voluntary consent; Are able to have a MRI; Understand French or English; NAFLD/NASH subjects: Have a su [...]
2024-02-05
minor
3 amendments v3-v5
3 re-verifications since 2021-01-18, no change to tracked fields
2019-10-25
minor
Study Identification, Study Status v2
Primary completion date2023-09-01→2024-10-30
Completion date2023-09-01→2024-10-30
Start date2018-09-07→2019-10-23
2018-09-20
notable
Not Yet Recruiting→Recruiting Study Status, Arms and Interventions, Outcome Measures, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2023-08-01→2023-09-01
Completion date2023-08-01→2023-09-01
Start dateestimated 2018-08-01→confirmed 2018-09-07
InterventionsAcoustic radiation force impulse, magnetic resonance elastography (Device)→Acoustic radiation force impulse (ARFI), magnetic resonance elastography (MRE) (Device)
Secondary endpoints4 entries, revised
AcousticLiver Radiationstiffness Force Impulse (ARFI)-determined liverby ARFI Liver stiffness Magnetic Resonance Elastography (MRE)-determined liverby stiffnessMRE Magnetic Resonance Imaging (MRI) cine-tagging of cardiac-induced motion for stagingStaging liver fibrosis
Primary endpoints1 entry, revised
Histology-determined fibrosisFibrosis stage
Study sitesdetails revised at 1 of 1 site
2018-06-19
minor
Original filing
Nonalcoholic fatty liver disease is the most common liver disease in Western countries, due in large part to its association with type 2 diabetes and obesity. The more advanced form of this disease is known as nonalcoholic steatohepatitis (NASH). If left untreated, NASH can evolve to cirrhosis, the late stage of fibrosis. Once cirrhosis is established, patients are at increased risk of developing gastrointestinal bleeding, liver cancer and liver failure that may require transplantation. A liver biopsy is currently needed to diagnose the severity of fatty liver disease but this is usually not indicated in asymptomatic patients. This procedure requires the insertion of a needle inside the liver to remove a small piece of tissue for examination under microscope. Liver biopsy is an invasive procedure with a small risk of major complications such as bleeding in 0.5% of cases. It is also affected by sub-optimal sampling leading to diagnostic errors Ultrasound is optimum for screening patients with or without symptoms because it is a safe and widely available technology to scan the whole liver. Members of our team have developed Advanced ultrasound techniques that provide unique information not possible with state-of-the-art techniques. Unlike liver biopsy, these techniques would be applicable even in asymptomatic patients because it is non-invasive. This research proposal proposes a novel approach for diagnosis of NASH and will be the first study to measure individual components of NASH (fat, inflammation and fibrosis) with quantitative ultrasound (QUS) scores. This study is timely because NASH is the second leading cause of liver transplantation in North America and is predicted to become the leading indication in the near future.
Trial Details
NCT Number NCT03572465
Lead Sponsor Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators: McGill University Health Centre/Research Institute of the McGill University Health Centre, Canadian Institutes of Health Research (CIHR), Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Conditions Nonalcoholic Fatty Liver Disease (NAFLD), Nonalcoholic Steatohepatitis (NASH)
Enrollment 102 participants
Start Date 2019-10-23
Primary Completion 2026-10-31 (estimated)
Study Completion 2027-02-28 (estimated)
Updated on ClinicalTrials.gov 2026-09-16