MRI Gadopiclenol Enhanced Imaging of CNS Tumors

Image Clinical Trial

Official title: A Pilot Study of Gadopiclenol for Imaging Central Nervous System (CNS) Tumors at Point of Care Magnetic Resonance Imaging (MRI)

Status Not yet recruiting

Clinical Trial Summary

The purpose of this pilot study is to compare a standard of care MRI scan to a non-standard of care MR imaging with portable (0.064 Tesla) MRI following the administration of non-SOC contrast called Gadopiclenol on 10 subjects with known brain tumors. Participants will be randomized to receive either standard MRI or portable MRI first following contrast injection

Clinical Trial Description

This study compares a routine MRI scan with a new portable MRI scanner known as the "Hyperfine" using a contrast dye called Gadopiclenol, the contrast is FDA approved. If participants choose to participate in this study, they will receive two MRI scans on the same day. One on the traditional standard of care MRI scanner and the other on the new portable Hyperfine MRI. The Hyperfine MRI scanner is not FDA approved due to being a very low risk medical device. However, the device is compliant with all of the FDA requirements regarding design control regulations and risk analysis. Participants will only receive one contrast injection that will be used for both scans. The selection of which scan is given first will be randomly selected (50/50 chance). Participation in this study will last two days. The first day participants will receive both MRI scans and the second day participants will receive a phone call from the research staff to check on them. ;

Related Conditions & MeSH terms

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• NCT number: NCT06127810
• Study type: Observational
• Source: Medical University of South Carolina
• Contact: Samuel L Bidwell
• Phone: 843-792-2305
• Email: bidwells@musc.edu
• Status: Not yet recruiting
• Start date: June 1, 2024
• Completion date: November 30, 2024