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

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ClinicalTrials.gov Identifier: NCT01829386
Recruitment Status : Enrolling by invitation
First Posted : April 11, 2013
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Neeraj Chaudhary MD MRCS FRCR, 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.


Condition or disease Intervention/treatment
Stroke Other: MRI scans with non heme iron levels

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.


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Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron

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 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.





Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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.

Information from the National Library of Medicine

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


Locations
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United States, Michigan
University of Michigan Hospital
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
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Principal Investigator: Neeraj Chaudhary, MD MRCS FRCF University of Michigan

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Responsible Party: Neeraj Chaudhary MD MRCS FRCR, Principal Investigator, University of Michigan
ClinicalTrials.gov Identifier: NCT01829386     History of Changes
Other Study ID Numbers: HUM00067651
First Posted: April 11, 2013    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Iron
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs