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NCT02565446 · ClinicalTrials.gov registry record · NA
Transforming Non-Invasive Liver Disease Detection by MRE: The Hepatogram
A NA study, sponsored by Mayo Clinic.
- Completed
- Registry status
- NA
- Development phase
- 243
- Enrollment target
NCT02565446: Completed NA study, sponsored by Mayo Clinic.
NCT02565446 is a NA study that has completed, run by Mayo Clinic. The registered enrollment target is 243 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02565446, a NA study, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- NA
- Development phase
- 243 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- PROCEDURE Magnetic Resolution Elastography (MRE)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 243 participants |
| Start Date | 2015-09 |
| Est. Completion | 2022-11-17 |
| Phase | NA |
What the finished NCT02565446 record still lists
NCT02565446 is an interventional study that assigns participants to a tested intervention. The registered 243 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 1 intervention - of which Magnetic Resolution Elastography (MRE) is the first listed.
NCT02565446 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02565446 about?
NCT02565446 is a clinical study titled "Transforming Non-Invasive Liver Disease Detection by MRE: The Hepatogram". 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-invasi...
What is the current status of trial NCT02565446?
This trial is currently completed. It is a NA study. The enrollment target is 243 participants. The study started on 2015-09. Estimated completion is 2022-11-17.
What interventions are being tested in trial NCT02565446?
The interventions under investigation include: Magnetic Resolution Elastography (MRE) (PROCEDURE).
Who is sponsoring clinical trial NCT02565446?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02565446's enrollment target sits among peer trials
243 438th of 2000 higher than 1,562 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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