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MRI to Characterize and Predict CF Liver Disease in PUSH Cohort

NCT02979340 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 115

Last updated 2025-04-11

No results posted yet for this 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

Conditions

  • Cystic Fibrosis Liver Disease
  • Pancreatic Insufficiency

Interventions

PROCEDURE

MRI

non-invasive assessment of hepatic fibrosis and steatosis

Sponsors & Collaborators

  • Cystic Fibrosis Foundation

    collaborator OTHER

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

    lead NIH

Principal Investigators

  • Ed Doo, MD · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  • Averell Sherker, MD · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Eligibility

Min Age
6 Years
Max Age
26 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-27
Primary Completion
2019-12-27
Completion
2019-12-27

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02979340 on ClinicalTrials.gov