MRI to Characterize and Predict CF Liver Disease in PUSH Cohort
NCT ID: NCT02979340
Last Updated: 2025-04-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
115 participants
OBSERVATIONAL
2017-01-27
2019-12-27
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Prediction by Ultrasound of the Risk of Hepatic Cirrhosis in Cystic Fibrosis
NCT01144507
Development of Novel MRI Methods for Detecting, Discriminating, and Measuring Liver Fibrosis and Congestion in Fontan Patients
NCT03539757
Methods to Detect Liver Fibrosis
NCT03027700
Functional MRI to Determine Severity of Cirrhosis
NCT03623360
Clinical Correlation Evaluation of the LIVERFASt Test for Diagnosing Important Liver Lesions of Fibrosis and Steatosis Against Magnetic Resonance Elastography (MRE) for Liver Fibrosis and MR-based Assessment of Steatosis, in Adult US Population.
NCT06797596
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Blinded radiology review of imaging sequences will be performed by a local study radiologist with central review performed by the Imaging Core. Analysis by the Imaging Core will include calculation of the liver stiffness, liver and spleen volume, and hepatic and lipid content for all MRI studies.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
MRI
non-invasive assessment of hepatic fibrosis and steatosis
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
2. Internal appliance or hardware that is not compatible with MR.
3. Inability to obtain MRI within 6 months of US.
4. Inability to cooperate with MRI.
6 Years
26 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cystic Fibrosis Foundation
OTHER
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ed Doo, MD
Role: STUDY_DIRECTOR
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Averell Sherker, MD
Role: STUDY_DIRECTOR
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Towbin AJ, Ye W, Huang S, Karmazyn BW, Molleston JP, Masand P, Leung DH, Chang S, Narkewicz MR, Alazraki AL, Freeman AJ, Otto RK, Green N, Kamel IR, Karnsakul WW, Magee JC, Tkach J, Palermo JJ. Prospective study of quantitative liver MRI in cystic fibrosis: feasibility and comparison to PUSH cohort ultrasound. Pediatr Radiol. 2023 Oct;53(11):2210-2220. doi: 10.1007/s00247-023-05706-6. Epub 2023 Jul 28.
Related Links
Access external resources that provide additional context or updates about the study.
MRE is a study in the ChiLDReN Network
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CFLD-MRE
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.