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

Recruiting

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • Non heme iron levels on MRI Other
    Intervention Desc: MRI scans of the head will be performed to determine the amount of Non heme iron in areas of the brain of hemorrhagic stroke patients and hopefully predict the amount of brain damage. Each MRI will take up to 1 hour to complete and will be done on day 3, day 7, day 10, day 14 and day 30. Some of the (MRIs) Magnetic Resonance Imaging will be clinically indicated and sequences will be added to the clinical scan with each sequence adding 10 minutes to the scan. Some sequences will be done only for research.
    ARM 1: Kind: Experimental
    Label: Non heme iron levels on MRI
    Description: Intervention: Multiple MRI To develop a reliable MR based measurement of Non heme iron in brain tissue of patients with hemorrhagic stroke. We propose to intervene with multiple MRIs at various points after the hemorrhage such as at day 3, 7, 10, 14 to assess the non heme iron levels on MRI. To evaluate the role of iron chelators following a hemorrhagic stroke/parenchymal hemorrhage.

Trial Design

  • Masking: Open Label
  • Purpose: Diagnostic
  • Endpoint: Efficacy Study
  • Intervention: Single Group Assignment
  • Sampling: Non-Probability Sample

Trial Population

The study population includes men and women, aged 18-85 who have had a hemorrhagic stroke and who can safely have an MRI scan.

Outcomes

Type Measure Time Frame Safety Issue
Primary Assessment of iron levels in patients with hemorrhagic stroke 30 days No

Sponsors