Development of 4D Flow MRI for Risk Stratification of Variceal Bleeding in Cirrhosis

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Wisconsin, Madison

About this trial

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.

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Ensure Plus®
  • Pre-clinical validation contrast enhanced MRI
  • Clinical validation MRI
  • Pre-clinical validation contrast enhanced MRI + fasting

Treatment groups

146 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Sponsors and collaborators

University of Wisconsin, Madison

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator