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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02565446
• Other study ID #: 15-003148
• Secondary ID: K23DK115594
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Est. completion date: November 17, 2022

Study information

• Verified date: October 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 243
• Est. completion date: November 17, 2022
• Est. primary completion date: November 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Obesity

Intervention

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

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The role of MRE as a non-invasive tool for estimation of inflammation and fibrosis in NAFLD.	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.	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.

External Links

•   Mayo Clinic Clinical Trials