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NCT04591106 · ClinicalTrials.gov registry record
Quantifying Body Composition and Liver Disease in Children Using Free-Breathing MRI and MRE
A clinical trial of NASH - Nonalcoholic Steatohepatitis and NAFLD, sponsored by University of California, Los Angeles.
- Completed
- Registry status
- 135
- Enrollment target
- 1
- Study location
NCT04591106: Completed study of NASH - Nonalcoholic Steatohepatitis and NAFLD, sponsored by University of California, Los Angeles.
NCT04591106 is a study of NASH - Nonalcoholic Steatohepatitis and NAFLD that has completed, run by University of California, Los Angeles. The registered enrollment target is 135 participants, below the 257-participant average among 28 other NASH - Nonalcoholic Steatohepatitis trials with a reported enrollment target (47% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04591106, a study of NASH - Nonalcoholic Steatohepatitis and NAFLD, has completed, sponsored by University of California, Los Angeles.
- COMPLETED
- Registry status
- 135 participants
- Enrollment target
- 1
- Study location
Study Summary
Magnetic resonance imaging (MRI) is used to measure liver fat content and fatty tissues in the body, and magnetic resonance elastography (MRE) is used to measure liver stiffness. The information from MRI and MRE are used to understand risk factors and diagnose liver diseases, such as fatty liver disease and liver fibrosis. However, current MRI and MRE scans need to be performed during a breath-hold, which may be challenging or impossible in children and infants. The goal of this research project is to develop and evaluate new free-breathing MRI and MRE technology to improve the comfort and diagnostic accuracy for children and infants.
Primary Outcome
Liver proton density fat fraction (PDFF; 0 to 100%) is an MRI based measurement of liver fat content. The liver PDFF measured by the new free-breathing MRI technique will be compared with standard breath-holding MRI in terms of the concordance correlation coefficient. The repeatability of liver PDFF will be measured in terms of the coefficient of variation between two scans. In addition, the diagnostic performance of MRI liver PDFF to detect liver fat will be validated against liver biopsy.
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Magnetic resonance imaging (MRI)
- DIAGNOSTIC_TEST Magnetic resonance elastography (MRE)
- DEVICE Prototype MRE soft flexible passive transducer paddle
Study Locations (1)
California
- UCLA Medical Center - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 135 participants |
| Start Date | 2021-02-17 |
| Est. Completion | 2026-02-28 |
What the finished NCT04591106 record still lists
NCT04591106 is an observational study that tracks outcomes without assigning an intervention. The registered 135 participants enrollment target is mid-sized for trials with a published cap, below the 257-participant average among 28 other NASH - Nonalcoholic Steatohepatitis trials with a reported enrollment target (47% lower).
The record links to 2 conditions, with NASH - Nonalcoholic Steatohepatitis appearing as the primary indexed condition, and to 3 interventions - of which Magnetic resonance imaging (MRI) is the first listed.
NCT04591106 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04591106 about?
NCT04591106 is a clinical study titled "Quantifying Body Composition and Liver Disease in Children Using Free-Breathing MRI and MRE". Magnetic resonance imaging (MRI) is used to measure liver fat content and fatty tissues in the body, and magnetic resonance elastography (MRE) is used to measure liver stiffness. The information from MRI and MRE are used to understand risk factors and diagnose liver diseases, such as fatty liver dis...
What is the current status of trial NCT04591106?
This trial is currently completed. The enrollment target is 135 participants. The study started on 2021-02-17. Estimated completion is 2026-02-28.
What conditions does trial NCT04591106 study?
This clinical trial studies the following conditions: NASH - Nonalcoholic Steatohepatitis, NAFLD.
What interventions are being tested in trial NCT04591106?
The interventions under investigation include: Magnetic resonance imaging (MRI) (DIAGNOSTIC_TEST), Magnetic resonance elastography (MRE) (DIAGNOSTIC_TEST), Prototype MRE soft flexible passive transducer paddle (DEVICE).
Who is sponsoring clinical trial NCT04591106?
This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04591106 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04591106's enrollment target sits among peer trials
135 13th of 28 higher than 16 of 28 other NASH - Nonalcoholic Steatohepatitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NASH - Nonalcoholic Steatohepatitis 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.
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