MRI to Characterize and Predict CF Liver Disease in PUSH Cohort

Completed

Conditions studied: Cystic Fibrosis Liver Disease, Pancreatic Insufficiency

In brief

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

Key facts

Study ID

NCT02979340

Run by

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

People needed

115

Starts

2017-01-27

Expected to finish

2019-12-27

Last updated by the study team

2025-04-11

Who can join

Age: 6 and older, up to 26. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Currently enrolled in longitudinal follow up in PUSH study at a site with MR elastography.

You may not qualify if…

• Age under 6 years (all current patients at time of opening of this study will be greater than 6 years of age).
• Internal appliance or hardware that is not compatible with MR.
• Inability to obtain MRI within 6 months of US.
• Inability to cooperate with MRI.

Where it is running

• Children's Hospital Colorado — Aurora, Colorado, United States
• Children's Healthcare of Atlanta — Atlanta, Georgia, United States
• Riley Hospital for Children — Indianapolis, Indiana, United States
• Johns Hopkins School of Medicine — Baltimore, Maryland, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Cincinnati Children's Hospital Medical — Cincinnati, Ohio, United States
• Texas Children's Hospital — Houston, Texas, United States
• Seattle Children's Hospital — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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