141
Participants
Start Date
October 28, 2021
Primary Completion Date
April 30, 2026
Study Completion Date
April 30, 2026
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.
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.
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."
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.
RECRUITING
University of Wisconsin, Madison, Madison
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
University of Wisconsin, Madison
OTHER