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This study will identify a dose of ferumoxytol that can reliably detect changes in blood flow/volume in response to non-drug stimuli. The study will determine whether signal detection for functional magnetic resonance imaging (fMRI) using ferumoxytol is better than that for blood oxygen level-dependent (BOLD) fMRI in response to sensory stimulation. The following procedures will be conducted in each of two study periods: arterial spin labeling (ASL) imaging study with increasing exposure to carbon dioxide (CO2); BOLD fMRI study with sensory stimulation; MRI studies with sensory stimulation in the presence of increasing doses of ferumoxytol; MRI study with increasing exposure to CO2 in the presence of ferumoxytol. There will be a 3-week interval between the two study periods. The study will enroll 8 subjects, but an additional 4 subjects are permitted to enroll to preserve study power.
Study Design: Translational Medicine - Imaging Platform Development
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All Participants | Experimental | fMRI studies with sensory stimulation in the presence of 0 mg, 250 mg, 350 mg, and 510 mg cumulative doses of ferumoxytol |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fMRI with sensory stimulation | Procedure | BOLD fMRI study with sensory stimulation followed by fMRI in the presence of increasing concentrations of ferumoxytol (Ferahemeâ„¢) |
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| Measure | Description | Time Frame |
|---|---|---|
| Magnitude of the MRI percent signal change in response to sensory stimulation without administration of ferumoxytol (BOLD fMRI) | 45 minutes after initiation of imaging procedures | |
| Magnitude of the MRI percent signal change in response to sensory stimulation following administration of the first dose of ferumoxytol (250 mg) | 55 minutes after initiation of imaging procedures | |
| Magnitude of the MRI percent signal change in response to sensory stimulation following administration of the second dose of ferumoxytol (100 mg, total cumulative dose of 350 mg) | 70 minutes after initiation of imaging procedures | |
| Magnitude of the MRI percent signal change in response to sensory stimulation following administration of the third dose of ferumoxytol (180 mg, total cumulative dose of 510 mg) | 85 minutes after initiation of imaging procedures |
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Inclusion Criteria:
Exclusion Criteria:
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