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The sponsor backed out of the trial.
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| Name | Class |
|---|---|
| Guerbet | INDUSTRY |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3T Contrast Enhanced Images First |
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| 0.064 Contrast Enhanced Images First |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CE MRI on 0.064T Scanner | Device | Pt will undergo contrast enhanced images using Gadopiclenol on Hyperfine MRI |
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| Measure | Description | Time Frame |
|---|---|---|
| Visibility of lesions | Visibility of lesions and diagnostic capabilities of 0.068T MRI | 1 Day |
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Inclusion Criteria
Exclusion Criteria
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Patient presenting, at the time of inclusion, with known or highly suspected focal areas of disrupted Blood Brain Barrier (BBB) due to primary or secondary tumor/s.
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| ID | Term |
|---|---|
| C000656634 | gadopiclenol |
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| Gadopiclenol | Drug | Subjects will receive Gadopiclenol instead of standard of care contrast |
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