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NCT04867954 · ClinicalTrials.gov registry record

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

A clinical trial of Cirrhosis, Liver and Gastroesophageal Varices, sponsored by University of Wisconsin, Madison.

Recruiting
Registry status
146
Enrollment target
1
Study location

NCT04867954: Recruiting study of Cirrhosis, Liver and Gastroesophageal Varices, sponsored by University of Wisconsin, Madison.

NCT04867954 is a study of Cirrhosis, Liver and Gastroesophageal Varices that is actively recruiting participants, run by University of Wisconsin, Madison. The registered enrollment target is 146 participants, below the 238-participant average among 34 other Cirrhosis, Liver trials with a reported enrollment target (39% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04867954, a study of Cirrhosis, Liver and Gastroesophageal Varices, is actively recruiting participants, sponsored by University of Wisconsin, Madison.

RECRUITING
Registry status
146 participants
Enrollment target
1
Study location

Study 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 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.

Primary Outcome

Receiver operation characteristic (ROC) curve analysis will be performed to determine the diagnostic accuracy of 4D flow MRI to differentiate high-risk GEV from absent or low-risk GEV. The area under the curve (AUC) will be estimated for each flow measurement with 95% confidence intervals. The primary analysis is based on fractional flow change in the portal vein.

Conditions Studied

Cirrhosis, Liver Gastroesophageal Varices Fontan Procedure

Interventions

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

Study Locations (1)

Wisconsin

  • University of Wisconsin, Madison - Madison

Trial Details

FieldValue
Enrollment Target 146 participants
Start Date 2021-10-28
Est. Completion 2026-04
University of Wisconsin, Madison

1,039 total trials

What NCT04867954 shows while recruiting

NCT04867954 is an observational study that tracks outcomes without assigning an intervention. The registered 146 participants enrollment target is mid-sized for trials with a published cap, below the 238-participant average among 34 other Cirrhosis, Liver trials with a reported enrollment target (39% lower).

The record links to 3 conditions, with Cirrhosis, Liver appearing as the primary indexed condition, and to 4 interventions - of which Ensure Plus® is the first listed.

NCT04867954 reports a single indexed study location in Wisconsin.

Frequently Asked Questions

What is clinical trial NCT04867954 about?

NCT04867954 is a clinical study titled "Development of 4D Flow MRI for Risk Stratification of Variceal Bleeding in Cirrhosis". 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 character...

What is the current status of trial NCT04867954?

This trial is currently recruiting. The enrollment target is 146 participants. The study started on 2021-10-28. Estimated completion is 2026-04.

What conditions does trial NCT04867954 study?

This clinical trial studies the following conditions: Cirrhosis, Liver, Gastroesophageal Varices, Fontan Procedure.

What interventions are being tested in trial NCT04867954?

The interventions under investigation include: Ensure Plus® (OTHER), Pre-clinical validation contrast enhanced MRI (OTHER), Clinical validation MRI (OTHER), Pre-clinical validation contrast enhanced MRI + fasting (OTHER).

Who is sponsoring clinical trial NCT04867954?

This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04867954 being conducted?

This trial has 1 study location across Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Cirrhosis, Liver

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04867954's enrollment target sits among peer trials

146 15th of 34 higher than 20 of 34 other Cirrhosis, Liver trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Cirrhosis, Liver trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT04867954

Source: ClinicalTrials.gov NCT04867954, the US trial registry maintained by the National Library of Medicine. NCT04867954 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.