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

RecruitingOBSERVATIONAL
Enrollment

141

Participants

Timeline

Start Date

October 28, 2021

Primary Completion Date

April 30, 2026

Study Completion Date

April 30, 2026

Conditions
Cirrhosis, LiverGastroesophageal Varices
Interventions
OTHER

Ensure Plus®

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.

OTHER

Pre-clinical validation contrast enhanced MRI

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.

OTHER

Clinical validation MRI

"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."

OTHER

Pre-clinical validation contrast enhanced MRI + fasting

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.

Trial Locations (1)

53704

RECRUITING

University of Wisconsin, Madison, Madison

All Listed Sponsors
collaborator

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

NIH

lead

University of Wisconsin, Madison

OTHER