Clinical Trials Directory

Trials / Completed

CompletedNCT02565446

Transforming Non-Invasive Liver Disease Detection by MRE: The Hepatogram

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
243 (actual)
Sponsor
Mayo Clinic · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

A variety of liver insults lead to pathological changes in liver architecture that culminate in cirrhosis. While invasive liver biopsy was required to detect cirrhosis, the development of magnetic resonance elastography (MRE) has revolutionized our ability to detect liver fibrosis through non-invasive means that involve measurement of liver stiffness. However, a number of pathological findings occur in liver in response to various insults that precede cirrhosis and are clinically important to identify such as steatosis associated with NASH, inflammation associated with viral hepatitis, and congestion associated with cardiac hepatopathy. Detection of such entities provides essential diagnostic, prognostic, and treatment information but yet is not available non-invasively. Recent murine studies from this group of investigators has identified that MRE technology can be adapted to non-invasively detect these conditions. Implementing this into the practice will transform it by obviating the need for invasive liver biopsies in patients suspected of having such forms of suspected liver disease. This will differentiate Mayo from other institutions where such technology is not available. An additional aim of this study is to examine the impact of obstructive sleep apnea (OSA) on the pathogenesis of nonalcoholic fatty liver disease (NAFLD), both common comorbidities of obesity. Recent evidence indicates a potential link between OSA and severity of NASH and fibrosis, but the mechanisms of OSA- associated hypoxia on liver disease progression in NAFLD is unclear. This study offers the unique opportunity to analyze this association, as the study population will undergo routine evaluation for OSA, as part as the preoperative work-up prior to bariatric surgery.

Conditions

Interventions

TypeNameDescription
PROCEDUREMagnetic Resolution Elastography (MRE)Magnetic Resolution Elastography (MRE): Three-dimensional magnetic resonance elastography (3DMRE), Waves at frequencies of 30 Hz, 40 Hz, and 60 Hz.

Timeline

Start date
2015-09-01
Primary completion
2022-11-17
Completion
2022-11-17
First posted
2015-10-01
Last updated
2023-10-12

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02565446. Inclusion in this directory is not an endorsement.