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

Not Applicable

Completed

• Conditions: Fatty Liver; Obesity
• Interventions: Procedure: Magnetic Resolution Elastography (MRE)

• Registration Number: NCT02565446
• Lead Sponsor: Mayo Clinic

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-09-24
• Study First Submitted QC: 2015-09-29
• Study First Posted: 2015-10-01
• Primary Completion: 2022-11-17
• Study Completion: 2022-11-17
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-10
• Last Update Posted: 2023-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 243

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bariatric	Magnetic Resolution Elastography (MRE)	Obese adult subjects who are scheduled to undergo bariatric surgery
Clinical	Magnetic Resolution Elastography (MRE)	Subjects who received abdominal surgery for non-liver related indications (cholecystectomy, pancreatic cyst resection)

Primary Outcome Measures

Name	Time	Method
The role of MRE as a non-invasive tool for estimation of inflammation and fibrosis in NAFLD.	The outcome (correlation of liver histology with MR elastogram) will be assessed once, at the time of outpatient biopsy, then again 1 year later with a second biopsy and a second MRE. Outcomes will be assessed after second biopsy.	120 participants evaluated at Mayo clinic with a diagnoses of NAFLD who are at risk to have NASH. All subjects will undergo an MRE and outpatient liver biopsy.The liver tissue will be assessed for fat, inflammation, and fibrosis by pathology. We are looking for differentiation of simple steatosis from steatohepatitis and steatohepatitis with fibrosis by non-invasive measures such as MRE.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States