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

Summary

Participation Requirements

Description

The overall goal of this research is to implement advanced non-invasive 4D flow MRI biomarkers to predict the presence of treatable but potentially lethal GEV in patients with cirrhosis. This would facilitate the triage of patients with high-risk GEV to therapeutic EGD, while reducing unnecessary EG...

The overall goal of this research is to implement advanced non-invasive 4D flow MRI biomarkers to predict the presence of treatable but potentially lethal GEV in patients with cirrhosis. This would facilitate the triage of patients with high-risk GEV to therapeutic EGD, while reducing unnecessary EGD procedures in patients without them. The primary biological mechanism for development of GEV is elevated portal pressure and reversal of flow in the left gastric vein (LGV). Applying 4D flow MRI, investigators aim to detect and quantify reversed flow in the LGV to detect GEV at risk for bleeding. Aim 1: Perform pre-clinical validation of an optimized, accelerated radial 4D flow MRI strategy. Aim 2: Determine the diagnostic performance of radial 4D flow MRI, in cirrhotic adults including diagnostic accuracy to identify high-risk GEV using EGD as reference standard, and test-retest repeatability Aim 3: Evaluate the effects and added value of a meal challenge to assess for high-risk GEV. Aim 4: Compare the accuracy of 4D flow MRI to current non-invasive markers of liver disease. Research Procedures Pre-Clinical Validation (Phase 1): A total of 21 participants (7 healthy volunteers, 7 patients with small, low-risk, and 7 with large, high-risk GEV) will be enrolled. 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 screening 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 (Phase 2-3): A total of 100 patients diagnosed with cirrhosis will be enrolled. Participants will be asked to complete a single research visit, lasting approximately 2 hours, that will include the following procedures: Participants will be asked to fast for 12 hours prior to arriving. An IV will be placed and a blood sample collected (~11mL, if necessary). Participants will undergo a research MRI lasting approximately 1.5 hours (up to 1 hour of total scan time) All participants will be positioned in the MRI scanner for the initial scanning session (30 min) during which the first dose of GBCA (3/4 of total dose) 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 min) during which, a second dose of GBCA (1/4 of total dose) will be administered if required.

Tracking Information