NCT06127810

MRI Gadopiclenol Enhanced Imaging of CNS Tumors

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

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Image

Interventions

Type	Name	Description
DEVICE	CE MRI on 0.064T Scanner	Pt will undergo contrast enhanced images using Gadopiclenol on Hyperfine MRI
DRUG	Gadopiclenol	Subjects will receive Gadopiclenol instead of standard of care contrast

Timeline

• Start date: 2024-12-30
• Primary completion: 2024-12-30
• Completion: 2024-12-30
• First posted: 2023-11-13
• Last updated: 2025-02-04

Regulatory

• FDA-regulated drug study
• FDA-regulated device study