Clinical trial NCT02565446: Transforming Non-Invasive Liver Disease Detection by MRE: The Hepatogram
Official title: Transforming Non-Invasive Liver Disease Detection by MRE: The Hepatogram
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Fatty Liver
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2015-10-01
Enrollment: 243
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: INCLUSION CRITERIA

1. Age ≥ 18 years
2. Verbal and written fluency of the English Language
3. Able to consent

EXCLUSION CRITERIA

1. Absolute contraindications to MRI including pacemaker, automatic implantable cardioverter/defibrillator (AICD) device, cochlear implant, ventriculoperitoneal (VP) shunt, aneurysm clip, deep brain stimulator, and severe claustrophobia
2. Absolute contraindications to liver biopsy including coagulopathy
3. History of decompensated cirrhosis complicated by one or more of the following: esophageal variceal hemorrhage, ascites, hepatic encephalopathy, or spontaneous bacterial peritonitis.
4. Women who are pregnant or breastfeeding
5. History of liver transplantation or hepatic resection
6. History of primary or secondary hepatic malignancy
7. Current or previous excessive alcohol consumption within 6 months of study enrollment defined as \> 30 grams/day for men and \> 20 grams/day for women
8. Current or prior history of therapy for underlying liver disease including interferon-based medications, other antiviral agents, immunomodulatory therapy, biologic response modifier therapy, and complementary/alternative medications including (but not encompassing) milk thistle
9. Any severe medical condition that, in the opinion of the Principal Investigator, would serve as an exclusion criterion for study enrollment

Primary outcomes:
measure: The role of MRE as a non-invasive tool for estimation of inflammation and fibrosis in NAFLD.
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Alina Allen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Allen AM, Shah VH, Therneau TM, Venkatesh SK, Mounajjed T, Larson JJ, Mara KC, Schulte PJ, Kellogg TA, Kendrick ML, McKenzie TJ, Greiner SM, Li J, Glaser KJ, Wells ML, Chen J, Ehman RL, Yin M. The Role of Three-Dimensional Magnetic Resonance Elastography in the Diagnosis of Nonalcoholic Steatohepatitis in Obese Patients Undergoing Bariatric Surgery. Hepatology. 2020 Feb;71(2):510-521. doi: 10.1002/hep.30483. Epub 2019 Mar 15.