MRI Gadopiclenol Enhanced Imaging of CNS Tumors
- Registration Number
- NCT06127810
- Lead Sponsor
- Medical University of South Carolina
- Brief 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
- Detailed 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- 10
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description 3T Contrast Enhanced Images First CE MRI on 0.064T Scanner - 3T Contrast Enhanced Images First Gadopiclenol - 0.064 Contrast Enhanced Images First CE MRI on 0.064T Scanner - 0.064 Contrast Enhanced Images First Gadopiclenol -
- Primary Outcome Measures
Name Time Method Visibility of lesions 1 Day Visibility of lesions and diagnostic capabilities of 0.068T MRI
- Secondary Outcome Measures
Name Time Method