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Clinical Trial Summary

To determine if transient elastography (TE), when combined with ultrasound (US) pattern characterization can improve the prediction of progression to a nodular pattern on US. To confirm the feasibility of obtaining TE measurements in children with Cystic Fibrosis (CF) To prospectively assess whether TE data are associated with conventional laboratory markers of hepatic fibrosis To determine the variability of TE measurements taken at different sites in the same patient


Clinical Trial Description

A noninvasive assessment of hepatic fibrosis is desperately needed to advance the care of children with CF significant liver disease and to provide for measurements during clinical trials. That global assessment might serve as both a predictor/descriptor of disease course but also as a critical biomarker for clinical research. FibroScan® measurement of liver stiffness has great potential to fill this void. The underlying hypothesis of this proposal is that elastography in addition to US can improved the prediction of the development of a nodular liver on US and development of portal hypertension over time in children and young adults with CF. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03001388
Study type Observational
Source National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Contact
Status Active, not recruiting
Phase
Start date April 1, 2017
Completion date December 2022

See also
  Status Clinical Trial Phase
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Not yet recruiting NCT03264950 - Utility of Point Shear-wave Elastography to Assess for Hepatic & Pancreatic Fibrosis in Pediatric CF Patients N/A
Completed NCT03312140 - Examination of the Lipid Metabolism of the Liver After Choline Substitution in Cystic Fibrosis N/A
Recruiting NCT03961516 - Glycemic Characterization and Pancreatic Imaging Correlates in Cystic Fibrosis
Recruiting NCT04277819 - The Use of Novel Diagnostic Tools to Increase Detection of Early Fibrosis in Cystic Fibrosis Related Liver Disease to Improve Clinical Management
Completed NCT02979340 - MRI to Characterize and Predict CF Liver Disease in PUSH Cohort