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

Overview

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.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: March 30, 2022

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • Fontan patients
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • MR elastography data correlation to histologic data
    • Time Frame: 60 minutes
    • MR elastography of the liver data will be correlated with histopathologic data obtained from non-lesional liver tissue. Histologic fibrosis and congestion will be scored by a pathologist using semi-quantitative grading systems (e.g., METAVIR scoring system for fibrosis

Secondary Measures

  • MR T1 mapping data (corrected and uncorrected) correlation to histologic data
    • Time Frame: 60 minutes
    • MR T1 mapping liver data (corrected and uncorrected) will be correlated with histopathologic data obtained from non-lesional liver tissue. Histologic fibrosis and congestion will be scored by a pathologist using semi-quantitative grading systems (e.g., METAVIR scoring system for fibrosis)
  • MR T1rho data correlation to histologic data
    • Time Frame: 60 minutes
    • MR T1rho liver data will be correlated with histopathologic data obtained from non-lesional liver tissue. Histologic fibrosis and congestion will be scored by a pathologist using semi-quantitative grading systems (e.g., METAVIR scoring system for fibrosis)
  • MR T2 mapping data correlation to histologic data
    • Time Frame: 60 minutes
    • MR T2 mapping liver data will be correlated with histopathologic data obtained from non-lesional liver tissue. Histologic fibrosis and congestion will be scored by a pathologist using semi-quantitative grading systems (e.g., METAVIR scoring system for fibrosis)
  • MR Diffusion weighted data correlation to histologic data
    • Time Frame: 60 minutes
    • MR Diffusion weighted liver data will be correlated with histopathologic data obtained from non-lesional liver tissue. Histologic fibrosis and congestion will be scored by a pathologist using semi-quantitative grading systems (e.g., METAVIR scoring system for fibrosis)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 8 Years

Maximum Age: 99 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Children’s Hospital Medical Center, Cincinnati
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jonathan Dillman, MD,MSc, Principal Investigator, Children’s Hospital Medical Center, Cincinnati

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