Non-Heme Iron Load Quantification in the Brain - MRI of Patients With Stroke
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01829386|
Recruitment Status : Enrolling by invitation
First Posted : April 11, 2013
Last Update Posted : April 16, 2019
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.
|Condition or disease||Intervention/treatment|
|Stroke||Other: MRI scans with non heme iron levels|
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.
|Study Type :||Observational|
|Estimated Enrollment :||10 participants|
|Official Title:||Non-Heme Iron Load Quantification in the Brain on MRI in Patients With Hemorrhagic Stroke|
|Study Start Date :||January 2013|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
Non heme iron levels on MRI
Intervention: MRI scans To develop a reliable MR based measurement of Non-heme iron in brain tissue of patients with hemorrhagic stroke : on day 3, 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.
Other: MRI scans with non heme iron levels
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 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.
- Assessment of iron levels in patients with hemorrhagic stroke [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01829386
|United States, Michigan|
|University of Michigan Hospital|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Neeraj Chaudhary, MD MRCS FRCF||University of Michigan|