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

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This trial will evaluate a non-invasive brain imaging technique QUTE-CE MRI and validate the
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.

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.
We found this trial at
1
site
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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mi
from
Boston, MA
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