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

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ClinicalTrials.gov Identifier: NCT02565446
Recruitment Status : Recruiting
First Posted : October 1, 2015
Last Update Posted : October 11, 2017
Sponsor:
Information provided by (Responsible Party):
Vijay Shah, M.D., 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.


Condition or disease Intervention/treatment Phase
Obesity Fatty Liver Device: Magnetic Resolution Elastography Procedure: Bariatric surgery Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Transforming Non-Invasive Liver Disease Detection by MRE: The Hepatogram
Study Start Date : September 2015
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : December 2019

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Arm Intervention/treatment
MRE
To evaluate new MRE sequence that is capable of distinguishing liver fibrosis and inflammation. MRE has emerged as the potential alternative to invasive liver biopsy and possibly "the reference standard for non-invasive diagnosis of liver fibrosis". All 80 participants undergoing bariatric surgery will complete a non-invasive determination of liver inflammation and fibrosis by MRE. The proposed sample size for this experiment will be calculated based on sensitivity and specificity of MRE for differentiating various stages of fibrosis. We are looking for differentiation of simple steatosis from steatohepatitis and steatohepatitis with fibrosis.
Device: Magnetic Resolution Elastography
Correlation between histology and MRE with respect to liver fibrosis and inflammation.

Procedure: Bariatric surgery
Recruitment will be of patients who are scheduled to undergo bariatric surgery. During the time of surgery a liver biopsy will be taken clinically to identify liver disease. In addition, liver and fat tissue will be obtained for research purposes.




Primary Outcome Measures :
  1. The role of MRE as a non-invasive tool for estimation of inflammation and fibrosis in NAFLD. [ Time Frame: The outcome (correlation of liver histology with MR elastogram) will be assessed once, at the time of bariatric surgery. The enrollment will span over 14 months (10/2015 - 12/2016). No subsequent outcomes will be assessed after bariatric surgery. ]
    80 participants undergoing bariatric surgery will complete a non-invasive determination of liver inflammation and fibrosis by MRE. All subjects will undergo liver biopsy at the time of bariatric surgery. 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.


Secondary Outcome Measures :
  1. Severity of liver fibrosis and adipose tissue dysfunction in obese patients with and without obstructive sleep apnea. [ Time Frame: Cross-sectional estimation of liver and adipose tissue histology between subjects with and without sleep apnea will be assessed once, at the time of bariatric surgery.The enrollment will span over 14 months (10/2015 - 12/2016). ]
    80 participants undergoing bariatric surgery will be assessed on parallel with the obesity epidemic, obstructive sleep apnea (OSA) affects millions of people in the US (approximately 50% of the obese subjects) and may represent an additional risk factor for liver fibrosis progression in patients with NAFLD. We will assess whether subjects with sleep apnea have worse fibrosis in the liver and fat tissue compared to subjects without sleep apnea.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02565446


Contacts
Contact: Suzanne M Greiner 507-284-5010 greiner2.suzanne@mayo.edu

Locations
United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Vijay Shah, MD Mayo Clinic

Responsible Party: Vijay Shah, M.D., PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02565446     History of Changes
Other Study ID Numbers: 15-003148
First Posted: October 1, 2015    Key Record Dates
Last Update Posted: October 11, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Liver Diseases
Fatty Liver
Digestive System Diseases