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

• ClinicalTrials.gov Identifier: NCT01829386
• Recruitment Status: Recruiting
• First Posted: April 11, 2013
• Last Update Posted: December 29, 2020
• Sponsor: University of Michigan
• Collaborator: National Institute of Neurological Disorders and Stroke (NINDS)
• Information provided by (Responsible Party): Neeraj Chaudhary MD MRCS FRCR, University of Michigan

Tracking Information

• First Submitted Date: April 8, 2013
• First Posted Date: April 11, 2013
• Last Update Posted Date: December 29, 2020
• Study Start Date: January 2013
• Estimated Primary Completion Date: October 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 10, 2013)

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.

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Non-Heme Iron Load Quantification in the Brain - MRI of Patients With Stroke
• Official Title: Non-Heme Iron Load Quantification in the Brain on MRI in Patients With Hemorrhagic Stroke

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.

• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study 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.
• Condition: Stroke

Intervention

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.

Study Groups/Cohorts

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.

Intervention: Other: MRI scans with non heme iron levels

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: April 10, 2013): 10
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: October 2021
• Estimated Primary Completion Date: October 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 85 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Neeraj Chaudhary, MD MRCS FRCR; 734-763-2082

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01829386
• Other Study ID Numbers: HUM00067651; R21NS099684 ( U.S. NIH Grant/Contract ); R21NS104663 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Neeraj Chaudhary MD MRCS FRCR, University of Michigan
• Study Sponsor: University of Michigan
• Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)

Investigators

• Principal Investigator: Neeraj Chaudhary, MD MRCS FRCF; University of Michigan

• PRS Account: University of Michigan
• Verification Date: December 2020