Non-Heme Iron Load Quantification in the Brain - MRI of Patients With Stroke



Status:Enrolling by invitation
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 85
Updated:4/28/2018
Start Date:January 2013
End Date:December 2019

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Non-Heme Iron Load Quantification in the Brain on MRI in Patients With Hemorrhagic Stroke

This study will determine if MRI imaging can be used to estimate the amount of iron in areas
of the brain affected by a stroke. This may help future patients if the scan can be used to
predict the amount of brain damage and therefore the effects on the patient.

New research treatments are being used to reduce the amount of iron build-up in the brain.
The effects of that treatment may also be estimated using new MRI techniques.

Hemorrhagic stroke has devastating consequences. The mechanisms resulting in early and
delayed brain injury following a hemorrhagic stroke is poorly understood. One of the
mechanisms demonstrated in

animal studies points towards deposition of iron in the brain tissue following hemorrhage.
Preliminary data in animal studies also support a favorable effect of iron chelate agents.
Iron chelate agents are compounds that bind iron to them and may show the extent of neural
tissue damage.

Initial results of human trials based on this hypothesis demonstrated the safety of
increasing amounts of desferroxamine given to human patients. The evaluation of iron chelate
agents for hemorrhagic stroke is entering into phase II/III trials.

There is no modality at this date that can quantify the iron in tissue non invasively. Some
preliminary studies have demonstrated the role of MRI in identifying parenchymal iron
deposition in traumatic brain injury.

We propose to validate an MRI based method to not only identify but also quantify the non
heme iron levels deposited in brain tissue following hemorrhagic stroke. Once validated this
method will be a robust mechanism to reliably quantify tissue iron in the brain which then
can be closely followed through iron chelate therapy in a trial setting.

Inclusion Criteria:

1. Males and females between the age of 18 and 85 who have suffered a stroke confirmed by a
CT of the head.

Exclusion Criteria:

1. You cannot take part in this study unless you have evidence of having a stroke
(hemorrhage in your brain).

2. You cannot take part in this study if you are not able to safely have an MRI exam.

3. Women cannot take part in this study if they are pregnant.

4. Women may not participate in this study if they are attempting to become pregnant or
think they might be pregnant. We will provide a one-time pregnancy test for anyone who
is uncertain about being pregnant.

5. You cannot take part in this study if you have evidence of a large amount of
calcifications found on CT exams that have been performed as part of the clinical
evaluation for your current condition.
We found this trial at
1
site
Ann Arbor, Michigan 48109
Principal Investigator: Neeraj Chaudhary, MD MRCS FRCR
Phone: 734-763-2082
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mi
from
Ann Arbor, MI
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