Functional Magnetic Resonance Imaging
Conditions
Keywords
brain imaging
Brief summary
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.
Detailed description
Study Design: Translational Medicine - Imaging Platform Development
Interventions
PROCEDUREfMRI with sensory stimulation
BOLD fMRI study with sensory stimulation followed by fMRI in the presence of increasing concentrations of ferumoxytol (Feraheme™)
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
21 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Participant weighs approximately 55-75 kg and has a Body Mass Index (BMI) of 18-25 kg/m\^2 * Participant is in good health * Participant is a nonsmoker and/or has not used nicotine or nicotine-containing products for at least 6 months
Exclusion criteria
* Participant has a contraindication to MRI including cardiac pacemaker, brain aneurysm clip, implanted neurostimulator, insulin pump, cochlear implant, metal slivers in the eyes, or any other MRI-incompatible metal implants that cannot be safely removed * Participant has a condition that would limit his ability to complete MRI procedures, such as claustrophobia or chronic back pain * Participant plans to undergo MRI studies in the 3 months following the post-study visit * Participant has a history of hemochromatosis or other conditions of iron overload or disease of iron metabolism * Participant has a known sensitivity to ferumoxytol or iron-containing products or has a history of severe allergies, anaphylactic reaction, or intolerance to drugs and/or foods * Participant has a history of stroke, chronic seizures, or major neurological disorder * Participant is unable to refrain from the use of any medication, including prescription and non-prescription drugs or herbal remedies from approximately 2 weeks prior to the first dose of ferumoxytol until the post-study visit * Participant has a history of significant head injury/trauma with loss of consciousness lasting for 15 minutes and one or more of the following: a) recurring seizures resulting from head injury; b) persistent neurological or cognitive sequelae of the injury; c) cognitive rehabilitation following the injury
Design outcomes
Primary
| Measure | 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 |
Outcome results
None listed