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

Completed

• Conditions: Stroke
• Interventions: Other: MRI scans with non heme iron levels

• Registration Number: NCT01829386
• Lead Sponsor: University of Michigan

Brief Summary

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.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-04-08
• Study First Submitted QC: 2013-04-10
• Study First Posted: 2013-04-11
• Primary Completion: 2022-08-23
• Study Completion: 2022-08-23
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-24
• Last Update Posted: 2023-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non heme iron levels on MRI	MRI scans with non heme iron levels	Intervention: MRI scans To develop a reliable MR based measurement of Non-heme iron in brain tissue of patients with hemorrhagic stroke : on day 1, 14 and 30 after stroke to assess the non heme iron levels on MRI. To evaluate the role of iron chelators following a hemorrhagic stroke/parenchymal hemorrhage.

Primary Outcome Measures

Name	Time	Method
Assessment of iron levels in patients with hemorrhagic stroke	30 days	Create a non-invasive imaging modality to assess for iron levels in patients with hemorrhagic stroke. Validation of quantification of non heme iron in the brain.

Trial Locations

Locations (1)

University of Michigan Hospital; 🇺🇸 Ann Arbor, Michigan, United States