CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 243 enrolled
Drug / intervention
Magnetic Resolution Elastography (MRE)procedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02565446
NCT02565446N/ACompleted

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

Mayo Clinic·interventional·Posted Oct 1, 2015·Updated Oct 12, 2023

In Brief

A clinical study evaluating Magnetic Resolution Elastography (MRE) for Obesity and Fatty Liver. Completed, enrolled 243 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObesity, Fatty Liver
CountriesUnited States

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedOct 1, 2015
Enrollment StartSep 1, 2015
Primary CompletionNov 17, 2022
TodayJul 2, 2026
Enrollment to primary: 7.2 yearsPosted 10.8 years ago

Interventions

Magnetic Resolution Elastography (MRE)procedure

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