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

NCT03539757 | Terminated FDA Device

• 1 other identifier: CIN_FALD MRI
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Fibrosis

Keywords

Liver fibrosis; Fontan surgery; MRI; Novel Methods

Outcome Measures

Primary Outcomes (1)

• MR elastography data correlation to histologic data

  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

  60 minutes

Secondary Outcomes (4)

• MR T1 mapping data (corrected and uncorrected) correlation to histologic data

  60 minutes

• MR T1rho data correlation to histologic data

  60 minutes

• MR T2 mapping data correlation to histologic data

  60 minutes

• MR Diffusion weighted data correlation to histologic data

  60 minutes

Study Arms (1)

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.

Device: Non-Contrast Magnetic Resonance Imaging

Interventions

Non-Contrast Magnetic Resonance Imaging DEVICE

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.

Fontan patients

Eligibility Criteria

• Age: 8 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jonathan Dillman, MD,MSc

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2018
• First Posted: May 29, 2018
• Study Start: May 9, 2018
• Primary Completion: March 30, 2022
• Study Completion: March 30, 2022
• Last Updated: March 7, 2024

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)