TerminatedNot Applicable

Development of Novel MRI Methods for Detecting, Discriminating, and Measuring Liver Fibrosis and Congestion in Fontan Patients

Stopped: Due to lack of enrollment this study was permanatly closed March 2022. The incidence of FONTAN patients being referred for liver biospsies and occurance of COVID effected participants enrolled.

United States6 participantsStarted 2018-05-09

Plain-language summary

In this research study, the investigators will conduct a prospective cross-sectional study of pediatric and adult Fontan patients that will correlate a variety of quantitative MRI biomarkers with histopathologic data.

Who can participate

Age range8 Years – 99 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Single ventricle physiology congenital heart disease status post Fontan palliation * Undergoing clinically-indicated liver biopsy * Ability to tolerate 60 minutes in an MRI scanner without sedation Exclusion Criteria: * Known contraindication to MR imaging (e.g., implanted non-MRI compatible device) * Known or suspected pregnancy. Female subjects of child bearing potential will undergo urine pregnancy testing prior to imaging

What they're measuring

MR elastography data correlation to histologic data

Timeframe: 60 minutes

Trial details

NCT IDNCT03539757

SponsorChildren's Hospital Medical Center, Cincinnati

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-03-30

View on ClinicalTrials.gov More Liver Fibrosis trials