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

August 24, 2023 updated by: Neeraj Chaudhary MD MRCS FRCR, University of Michigan

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

34

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Neeraj Chaudhary, MD MRCS FRCR
  • Phone Number: 734-763-2082

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Collaborators

National Institute of Neurological Disorders and Stroke (NINDS)

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

August 23, 2022

Study Completion (Actual)

August 23, 2022

Study Registration Dates

First Submitted

April 8, 2013

First Submitted That Met QC Criteria

April 10, 2013

First Posted (Estimated)

April 11, 2013

Study Record Updates

Last Update Posted (Actual)

August 25, 2023

Last Update Submitted That Met QC Criteria

August 24, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00067651
  • R21NS099684 (U.S. NIH Grant/Contract)
  • R21NS104663 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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