Quantitative Non-Invasive Brain Imaging Using QUTE-CE MRI
Status: | Enrolling by invitation |
---|---|
Conditions: | Neurology |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | 18 - 80 |
Updated: | 9/14/2018 |
Start Date: | November 8, 2017 |
End Date: | August 2019 |
This trial will evaluate a non-invasive brain imaging technique QUTE-CE MRI and validate the
method with first-in-human studies.
method with first-in-human studies.
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.
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.
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.
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