Development of 4D Flow MRI for Risk Stratification of Variceal Bleeding in Cirrhosis
Key facts
- Who runs it
- University of Wisconsin, Madison
- Where
- Madison, United StatesSee the site
- Trial code
- Status
- Completed
- People taking part
- 84 people enrolled
- Started
- 28 Oct 2021
- Ended
- 26 Jun 2026
- Type of study
- Observational, 6 groups
- Treatments tested
- Ensure Plus®
- Pre-clinical validation contrast enhanced MRI
- Clinical validation MRI
- Pre-clinical validation contrast enhanced MRI + fasting
- Record updated
- 8 July 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
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Who can take part
- 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
- Adults (>18 years) with known cirrhosis
- Adults (>18 years) with Fontan repair and diagnosed FALD
Who cannot take part
- 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
- 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
- hypersensitivity reactions to both contrast agents
- patients with active GEV bleeding; known occlusive thrombus in portal vein, splenic vein, or superior mesenteric vein
- Hypersensitivity reactions to both contrast agents
- Hypersensitivity reactions to both contrast agents
- contraindications to MRI
- patients with recent treatment for varices with embolization, TIPS, or other endovascular treatment
- patients with large HCC with known PC involvement
- 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
- 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
Where in United States
- University of Wisconsin - MadisonMadison, United States
About the trial
What the trial wants to find out
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 change in the portal vein and elevated azygos flow.
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End-stage liver disease (cirrhosis) is characterized by advanced fibrosis, liver failure, and portal hypertension. There are many causes of cirrhosis, including viral hepatitis, alcohol abuse, and perhaps most importantly, non-alcoholic fatty liver disease (NAFLD) and its aggressive subset, non-alcoholic steatohepatitis (NASH). 3 million new cases of end-stage liver disease (cirrhosis) are expected over the next decade. In cirrhosis, portosystemic collaterals that shunt blood away from the liver develop due to increased portal pressure. Gastroesophageal varices (GEV) are the most clinically relevant because they can cause fatal internal bleeding. GEV bleeding carries ~20% mortality at 6 weeks, and ~34% overall mortality. Identification of at-risk varices, prior to bleeding, is of paramount importance to initiate primary prophylaxis. To identify and treat at-risk patients, current guidelines recommend regular esophagogastroduodenoscopy (EGD) and variceal band ligation. Detection of high-risk GEV is key to initiating primary prophylaxis, which can reduce mortality by 50-70%.
However, endoscopy is invasive and often unnecessary when no treatment is required. Therefore, the American Association for the Study of Liver Diseases has identified the development of "non-invasive markers that predict the presence of high-risk varices" as a major unmet need.
The 6 groups in the trial
- Healthy volunteers
7 healthy participants will be recruited.
Treatment: Pre-clinical validation contrast enhanced MRI
- Patients with small, low-risk GEV
Patients with small, low-risk Gastroesophageal varices (GEV) will be recruited.
Treatment: Pre-clinical validation contrast enhanced MRI
- Patients with large, high-risk GEV
Patients with large, high-risk Gastroesophageal varices (GEV) will be recruited.
Treatment: Pre-clinical validation contrast enhanced MRI
- Patients scheduled for screening or surveillance esophagogastroduodenoscopy (EGD)
100 patients diagnosed with cirrhosis and scheduled for screening or surveillance esophagogastroduodenoscopy (EGD) procedure will be recruited. Participants will complete a single research visit, lasting approximately 2 hours, that will include the following procedures: * Participants will fast for 12 hours prior to arriving. * An IV will be placed and a blood sample collected (\~11 mL, if necessary). * All participants will undergo research MRI lasting approximately 1.5 hours
Treatment: Ensure Plus® and Clinical validation MRI
- Obese patients
20 obese patients will be recruited
Treatment: Pre-clinical validation contrast enhanced MRI + fasting
- Participants with Fontan repair and diagnosed Fontal associated liver disease (FALD)
5 participants with Fontan repair and diagnosed FALD will be recruited.
Treatment: Ensure Plus® and Clinical validation MRI
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 8 July 2026