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

Cincinnati Children's Hospital Medical Center

Status: Terminated

Conditions: Liver Fibrosis

Treatments: Device: Non-Contrast Magnetic Resonance Imaging

Study type: Observational

Funder types: Other

Identifiers

NCT03539757

CIN_FALD MRI

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6 patients

Sex: All

Ages: 8 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

6 participants in 1 patient group

Fontan patients

Description:

Pediatric and adult Fontan patients will undergo MRI (Magnetic Resonance Imaging) of the liver using novel, non-contrast MRI methods. These MR methods will be used to detect, discriminate and measure liver fibrosis and congestion. The resulting quantitative imaging measurements will be correlated with histopathologic data obtained from a clinically-indicated liver biopsy.

Treatment:

Device: Non-Contrast Magnetic Resonance Imaging