NCT03539757

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 6 (actual)
• Sponsor: Children's Hospital Medical Center, Cincinnati · Academic / Other
• Sex: All
• Age: 8 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Liver Fibrosis

Interventions

Type	Name	Description
DEVICE	Non-Contrast Magnetic Resonance Imaging	The investigators plan to prospectively assess the correlation of liver fibrosis and congestion measurements obtained from novel, non-contrast MR imaging methods to histopathologic data obtained from a clinically-indicated liver biopsy in Fontan patients.

Timeline

• Start date: 2018-05-09
• Primary completion: 2022-03-30
• Completion: 2022-03-30
• First posted: 2018-05-29
• Last updated: 2024-03-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study