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MRI to Characterize and Predict CF Liver Disease in PUSH Cohort

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ClinicalTrials.gov Identifier: NCT02979340
Recruitment Status : Enrolling by invitation
First Posted : December 1, 2016
Last Update Posted : March 30, 2018
Sponsor:
Collaborator:
Cystic Fibrosis Foundation Therapeutics
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Brief 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


Condition or disease Intervention/treatment
Cystic Fibrosis Liver Disease Pancreatic Insufficiency Procedure: MRI

Detailed Description:

This proposal will be a cross sectional study of the current well-characterized PUSH cohort. Patients will receive an MRI at the time of their scheduled PUSH ultrasound. Ideally, the MRI will be performed the same day or a similar time point near liver ultrasound (+/-90 days, but Investigators will allow a larger window due to the slow progression of fibrosis).

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.


Study Type : Observational
Estimated Enrollment : 228 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Analysis of Prediction by Ultrasound of the Risk of Hepatic Cirrhosis in Cystic Fibrosis (PUSH) Cohort Using Advanced MRI to Characterize and Predict CF Liver Disease
Study Start Date : December 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019



Intervention Details:
  • Procedure: MRI
    non-invasive assessment of hepatic fibrosis and steatosis


Primary Outcome Measures :
  1. Change over Time in Liver stiffness and Lipid content over time using MRE [ Time Frame: BSL, Year 1, Year 2 ]
    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.



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Ages Eligible for Study:   6 Years to 26 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children aged 3 through 12 years of age at time of enrollment diagnosed with Cystic Fibrosis and pancreatic insufficiency and enrolled in the CFLD PUSH longitudinal study.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Age under 6 years (all current patients at time of opening of this study will be greater than 6 years of age).
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02979340


Locations
United States, Colorado
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
United States, Georgia
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
United States, Indiana
Riley Hospital for Children
Indianapolis, Indiana, United States, 46202
United States, Maryland
Johns Hopkins School of Medicine
Baltimore, Maryland, United States, 21217
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, Ohio
Cincinnati Children's Hospital Medical
Cincinnati, Ohio, United States, 45229
United States, Texas
Texas Children's Hospital
Houston, Texas, United States, 77030
United States, Washington
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Cystic Fibrosis Foundation Therapeutics
Investigators
Study Director: Ed Doo, MD National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study Director: Averell Sherker, MD National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Additional Information:
Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT02979340     History of Changes
Other Study ID Numbers: CFLD-MRE
U01DK062456 ( U.S. NIH Grant/Contract )
First Posted: December 1, 2016    Key Record Dates
Last Update Posted: March 30, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
Cystic Fibrosis Liver Disease
Pancreatic Insufficiency

Additional relevant MeSH terms:
Fibrosis
Cystic Fibrosis
Liver Diseases
Exocrine Pancreatic Insufficiency
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases