Clinical trial NCT03539757: Development of Novel MRI Methods for Detecting, Discriminating, and Measuring Liver Fibrosis and Congestion in Fontan Patients
Official title: Development of Novel MRI Methods for Detecting, Discriminating, and Measuring Liver Fibrosis and Congestion in Fontan Patients
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Liver Fibrosis
Keywords: Liver fibrosis
Fontan surgery
MRI
Novel Methods
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2018-05-29
Enrollment: 6
Sex: ALL
Minimum age (years): 8
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible subjects will be identified through Cincinnati Children's Hospital Medical Center's (CCHMC) cardiology or hepatology clinics, or through CCHMCs Fontan Management Program

Brief 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.

Detailed description: The purpose of this study is to develop noninvasive MRI methods for detecting, discriminating, and measuring liver fibrosis and congestion in the adolescent and adult Fontan population by correlating quantitative imaging measurements with histopathologic data, using a cross-sectional approach.

Over 5 years, approximately 40 pediatric and adult subjects (approximately 8 subjects per year) undergoing clinically-indicated liver biopsy for the evaluation of either 1) focal liver lesions/masses, or 2) suspected liver fibrosis/parenchymal disease will be recruited to participate in this study. Subjects will undergo research MR imaging within ±2 weeks of the liver biopsy procedure. A variety of MRI biomarkers will be correlated with histopathologic data obtained from the clinically indicated liver biopsy.

Eligibility criteria: 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

Primary outcomes:
measure: MR elastography data correlation to histologic data
timeFrame: 60 minutes
Secondary outcomes:
measure: MR T1 mapping data (corrected and uncorrected) correlation to histologic data
timeFrame: 60 minutes
measure: MR T1rho data correlation to histologic data
timeFrame: 60 minutes
measure: MR T2 mapping data correlation to histologic data
timeFrame: 60 minutes
measure: MR Diffusion weighted data correlation to histologic data
timeFrame: 60 minutes
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Jonathan Dillman, MD,MSc
role: PRINCIPAL_INVESTIGATOR
References: