Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Due to lack of enrollment this study was permanatly closed March 2022. The incidence of FONTAN patients being referred for liver biospsies and occurance of COVID effected participants enrolled.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| MR T1 mapping data (corrected and uncorrected) correlation to histologic data | 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) | 60 minutes |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Eligible subjects will be identified through Cincinnati Children's Hospital Medical Center's (CCHMC) cardiology or hepatology clinics, or through CCHMCs Fontan Management Program
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jonathan Dillman, MD,MSc | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| MR T1rho data correlation to histologic data | 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) | 60 minutes |
| MR T2 mapping data correlation to histologic data | 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) | 60 minutes |
| MR Diffusion weighted data correlation to histologic data | 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) | 60 minutes |
| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided