Status:
RECRUITING
Development of 4D Flow MRI for Risk Stratification of Variceal Bleeding in Cirrhosis
Lead Sponsor:
University of Wisconsin, Madison
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Cirrhosis, Liver
Gastroesophageal Varices
Eligibility:
All Genders
18+ years
Brief Summary
The goal of this research is to validate novel non-invasive Magnetic resonance imaging (MRI) biomarkers to detect Gastroesophageal varices (GEV) in patients with cirrhosis, including fractional flow c...
Detailed Description
The overall goal of this research is to implement advanced non-invasive 4D flow MRI biomarkers to predict the presence of treatable but potentially lethal GEV in patients with cirrhosis. This would fa...
Eligibility Criteria
Inclusion
- Inclusion Criteria for Aim 1:
- Healthy volunteers: Adults (\>18 years) with no known liver pathology
- Obese volunteers: Adults (\>18 years), no known liver pathology, body mass index (BMI) ≥ 35
- Patients: Adults (\>18 years) with known cirrhosis and known Gastroesophageal varices
- Exclusion Criteria for Aim 1:
- contraindications to MRI
- hypersensitivity reactions to both contrast agents
- patients with recent treatment for varices with embolization, TIPS, or other endovascular treatment
- patients with active GEV bleeding; known occlusive thrombus in portal vein, splenic vein, or superior mesenteric vein.
- patients with large HCC with known PC involvement.
- Inclusion criteria for Aim 2-4:
- Adults (\>18 years) with known cirrhosis scheduled for EGD to assess for GEV.
- Exclusion Criteria for Aim 2-4:
- Contraindications to MRI
- Recent treatment (\< 1 year) for varices
- Known occlusive thrombus in portal vein; splenic vein, or superior mesenteric vein
- Large hepatocellular carcinoma (HCC) with known PV involvement
- Hypersensitivity reactions to both contrast agents
- Participants requiring conscious sedation for imaging are not eligible; participants requiring mild, oral anxiolytics for the clinical MRI scan will be allowed to participate as long as the following criteria are met:
- The participant has their own prescription for the medication
- The informed consent process is conducted prior to the self-administration of the medication.
- The participant comes to the research visit with a driver.
- Inclusion Criteria for Aim 5:
- Adults (\>18 years) with Fontan repair and diagnosed FALD
- Exclusion Criteria for Aim 5:
- Contraindications to MRI
- Recent treatment (\< 1 year) for varices
- Known occlusive thrombus in portal vein; splenic vein, or superior mesenteric vein
- Large hepatocellular carcinoma (HCC) with known PV involvement
- Hypersensitivity reactions to both contrast agents
- Participants requiring conscious sedation for imaging are not eligible; participants requiring mild, oral anxiolytics for the clinical MRI scan will be allowed to participate as long as the following criteria are met:
- The participant has their own prescription for the medication
- The informed consent process is conducted prior to the self-administration of the medication.
- The participant comes to the research visit with a driver.
Exclusion
Key Trial Info
Start Date :
October 28 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
146 Patients enrolled
Trial Details
Trial ID
NCT04867954
Start Date
October 28 2021
End Date
April 1 2026
Last Update
December 17 2025
Active Locations (1)
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1
University of Wisconsin, Madison
Madison, Wisconsin, United States, 53704