Liver Fibrosis
Conditions
Keywords
Liver fibrosis, Fontan surgery, MRI, Novel Methods
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.
Interventions
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.
Sponsors
Children's Hospital Medical Center, Cincinnati
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
8 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MR elastography data correlation to histologic data | 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
| Measure | Time frame | Description |
|---|---|---|
| MR T1 mapping data (corrected and uncorrected) correlation to histologic data | 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 | 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 | 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 | 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) |
Countries
United States
Outcome results
None listed