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NCT02979340 · ClinicalTrials.gov registry record
MRI to Characterize and Predict CF Liver Disease in PUSH Cohort
A clinical trial, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- 115
- Enrollment target
NCT02979340: Completed study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
NCT02979340 is a clinical trial that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 115 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02979340 has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- 115 participants
- Enrollment target
Study Summary
Specific Aim 1. Determine if valid results of non-sedated MRI based assessments of liver stiffness and lipid content can be obtained in more than 90% of children and young adults with cystic fibrosis. Specific Aim 2. Determine hepatic lipid content using the HepaFat sequence and liver stiffness using MRE. Investigators will compare the results obtained by MRI with PUSH study grayscale ultrasounds in CF patients with normal, heterogeneous, homogeneous or nodular (cirrhotic) pattern on ultrasound. Specific Aim 3. Creation of an imaging core lab to centralize evaluation of MR imaging data, allow for remote image upload, electronic data storage, and remote image viewing/interpretation. This infrastructure will be utilized to standardize image post processing. Specific Aim 4. Using the longitudinal PUSH study, determine if MRI based imaging improves discrimination of subjects at risk for progression to advanced CF liver disease (development of cirrhosis) compared to using US imaging alone
Primary Outcome
Analysis of variance (ANOVA) will be used to compare the distribution of liver stiffness (in kPa) and lipid content measures between all groups defined by PUSH study grayscale ultrasounds results over time.
Interventions
- PROCEDURE MRI
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 115 participants |
| Start Date | 2017-01-27 |
| Est. Completion | 2019-12-27 |
What the finished NCT02979340 record still lists
NCT02979340 is an observational study that tracks outcomes without assigning an intervention. The registered 115 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which MRI is the first listed.
NCT02979340 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02979340 about?
NCT02979340 is a clinical study titled "MRI to Characterize and Predict CF Liver Disease in PUSH Cohort". Specific Aim 1. Determine if valid results of non-sedated MRI based assessments of liver stiffness and lipid content can be obtained in more than 90% of children and young adults with cystic fibrosis. Specific Aim 2. Determine hepatic lipid content using the HepaFat sequence and liver stiffness usi...
What is the current status of trial NCT02979340?
This trial is currently completed. The enrollment target is 115 participants. The study started on 2017-01-27. Estimated completion is 2019-12-27.
What interventions are being tested in trial NCT02979340?
The interventions under investigation include: MRI (PROCEDURE).
Who is sponsoring clinical trial NCT02979340?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
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