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Development of 4D Flow MRI for Risk Stratification of Variceal Bleeding in Cirrhosis
NCT04867954 · View on ClinicalTrials.gov ↗
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 146 participants |
| Start Date | 2021-10-28 |
| Est. Completion | 2026-04 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04867954
The ClinicalTrials.gov registry entry for NCT04867954 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 146 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Wisconsin, Madison, which has 943 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04867954 reports 1 study location spanning 1 distinct geographic area — top geographies include Wisconsin. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04867954?
This trial is sponsored by University of Wisconsin, Madison, which has 943 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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