Cerebrovascular Disorders
Conditions
Keywords
Magnetic Resonance Imaging, Ferumoxytol
Brief summary
This trial will evaluate a non-invasive brain imaging technique QUTE-CE MRI and validate the method with first-in-human studies.
Detailed description
This trial will evaluate a non-invasive brain imaging technique QUTE-CE MRI using Ferumoxytol as a contrast agent, and validate the method with first-in-human studies. Subjects who are already scheduled to receive ferumoxytol infusion will undergo MRI scans after the infusion. The ferumoxytol infusion itself is not a part of the study. The project will provide brain angiograms and establish a human cerebrovascular atlas that will enable future quantitative diagnosis of cerebrovascular abnormalities by revealing abnormal regions of the brain that characterize disease, a tool which doesn't currently exist, and which could lead to many exciting discoveries and clinical applications in neurology.
Interventions
DIAGNOSTIC_TESTQuantitative Magnetic Resonance Imaging
Radiological diagnosis
Sponsors
Massachusetts General Hospital
Northeastern University
National Institute on Drug Abuse (NIDA)
Theranano LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Between the ages of 18 to 80; * Able to understand written consent document and HIPAA authorization prior to initiation of study related procedures.
Exclusion criteria
* Known allergy to ferumoxytol or any intravenous iron preparation; * Iron saturation above the upper limit of normal; * Individuals with a contraindication to MRI, such as the presence of metallic prostheses or implanted metal device (e.g., infusion pump, defibrillator); * Individuals with known clinical conditions that may lead to iron overload including hemochromatosis, cirrhosis, or sickle cell disease; * Individuals with any serious medical condition that the investigator believes may place them at increased risk for an adverse event.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cerebrovascular Angiography | 0-4 hours after ferumoxytol infusion | Obtain angiograms of the cerebral vasculature from the MRI intensity data |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quantitative cerebral blood volume atlas | 0-4 hours after ferumoxytol infusion | Create cerebral blood volume atlas from the quantitative MRI intensity data |
Countries
United States
Outcome results
None listed