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

Part of paid clinical trials in Madison, Wisconsin.

Sponsor
University of Wisconsin, Madison
Study ID
NCT04867954
Status
Recruiting
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Conditions

  • Cirrhosis, Liver
  • Fontan Procedure
  • Gastroesophageal Varices

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Ensure Plus® — OTHER
    In-between two MRI exams, patients will ingest a standardized meal of two cans (16oz) of Ensure Plus® (Abbott Laboratories), providing a 700cal meal (13g protein, 11g fat, 50g carbohydrates), proven to elicit a strong hyperemic splanchnic response.
  • Pre-clinical validation contrast enhanced MRI — OTHER
    Participants will be asked to complete a single research visit that will include a contrast enhanced MRI scan lasting up to 1 hour. Participants will be asked to fast for at least 5 hours prior to the exam. Participants will be screened a final time for contraindications to contrast enhanced MR imaging; an IV will be placed; and participants will be positioned in the MR scanner, asked to lie as still as possible and to follow some breath hold instructions.
  • Clinical validation MRI — OTHER
    Participants will be screened for any previous reactions to Ferumoxytol or GBCAs and dosing will be consistent with standard of care. Participants will then undergo a research MRI lasting approximately 1.5 hours. * All participants will be positioned in the MRI scanner for the initial scanning session (30 min) during which a 1/2 or 3/4 of the full dose of gadolinium based contrast agent (GBCA) or the total dose of Ferumoxytol will be administered. * The first 50 participants will be removed from the scanner bore, repositioned, and scanned for an additional 15 minutes (repeatability testing). * All participants will then be removed from the scanner and asked to consume 16 ounces of Ensure Plus®. After 20 minutes, they will be repositioned in the scanner for an additional scanning session (15 minutes) during which, the remaining 1/4 or 1/2 dose of GBCA will be administered, if required.
  • Pre-clinical validation contrast enhanced MRI + fasting — OTHER
    Participants will be asked to complete a single research visit that will include a contrast enhanced MRI scan lasting up to 1.5 hours. Participants will be asked to fast for at least 5 hours prior to the exam. Participants will be screened a final time for contraindications to contrast enhanced MR imaging; an IV will be placed; and participants will be positioned in the MR scanner, asked to lie as still as possible and to follow some breath hold instructions.

Study Details

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.

Key Dates

Start date
Oct 28, 2021
Status verified
Dec 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
146 participants (estimated)

Arms

  • Arm: Healthy volunteers
    7 healthy participants will be recruited.
  • Arm: Patients with small, low-risk GEV
    Patients with small, low-risk Gastroesophageal varices (GEV) will be recruited.
  • Arm: Patients with large, high-risk GEV
    Patients with large, high-risk Gastroesophageal varices (GEV) will be recruited.
  • Arm: 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
  • Arm: Obese patients
    20 obese patients will be recruited
  • Arm: Participants with Fontan repair and diagnosed Fontal associated liver disease (FALD)
    5 participants with Fontan repair and diagnosed FALD will be recruited.

Primary Outcome Measure

Receiver operation characteristic (ROC) curve analysis to determine diagnostic accuracy [ Time Frame: 2 hours ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Wisconsin, MadisonMadisonWisconsin53704
Scott Reeder, MD, PhD (PRINCIPAL_INVESTIGATOR)

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