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Imaging Neuroinflammation in Epilepsy With Ferumoxytol MRI (IRONMAN)

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ClinicalTrials.gov Identifier: NCT02084303
Recruitment Status : Completed
First Posted : March 11, 2014
Last Update Posted : March 14, 2018
Sponsor:
Collaborator:
American Epilepsy Society
Information provided by (Responsible Party):
Barbara Jobst, Dartmouth-Hitchcock Medical Center

Brief Summary:
The investigators plan to study inflammation in the brain (neuroinflammation) in human patients with epilepsy using a novel, non-invasive technique that has been proven successful in humans with other neuroinflammatory diseases. This technique uses ferumoxytol, a drug with minimal side effects that is FDA-approved for the treatment of iron deficiency anemia, as the contrast agent in magnetic resonance imaging (MRI). The study will recruit epilepsy patients who are admitted to Dartmouth-Hitchcock Medical Center (DHMC) for video-electroencephalography (video-EEG) monitoring in order to evaluate their candidacy for curative brain surgery. During the hospital stay and after informed consent, the patient will receive a standard-dose intravenous injection of ferumoxytol, and undergo one session of MRI at 24-48 hours after the injection. The patient will also undergo a separate "baseline" MRI session (if not already done at DHMC) at admission or at more than four weeks after the injection but before any brain surgery. Brain regions that preferentially uptake ferumoxytol are localized by subtracting the post-injection MRI session from the "baseline" MRI session. The investigators will investigate whether these regions overlap with the epileptogenic focus, namely the region that generates epilepsy and is localized by video-EEG and other diagnostic measures. Lastly, for those patient participants who thereafter undergo brain surgery, DHMC neuropathologists will use special stains to detect and quantify neuroinflammation in brain tissue removed, and the results will serve as the reference for the investigators to measure the sensitivity and specificity of ferumoxytol-based MRI in detecting neuroinflammation.

Condition or disease Intervention/treatment Phase
Epilepsy Other: Ferumoxytol injection after focal epileptic seizure followed by iron-sensitive MRI Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Imaging Neuroinflammation in Epilepsy With Ferumoxytol MRI
Study Start Date : March 2014
Actual Primary Completion Date : March 29, 2015
Actual Study Completion Date : March 2, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Iron
Drug Information available for: Ferumoxytol

Arm Intervention/treatment
Ferumoxytol MRI
Ferumoxytol injection after focal epileptic seizure followed by iron-sensitive MRI.
Other: Ferumoxytol injection after focal epileptic seizure followed by iron-sensitive MRI



Primary Outcome Measures :
  1. Overlap of epileptogenic zone with brain regions that take up ferumoxytol [ Time Frame: up to 48 hours after epileptic seizure ]
    Ferumoxytol will be injected within one hour of epileptic event and iron-sensitive MRI will be conducted within 48 hours.


Secondary Outcome Measures :
  1. Immunohistochemical evidence of neuroinflammation in brain tissue that has taken up ferumoxytol [ Time Frame: Two years ]
    Brain tissue removed from those patients who undergo curative epilepsy surgery contains the epileptic focus. Histochemical analysis of abnormal areas of this brain tissue will be analyzed for correlation with areas of ferumoxytol uptake.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient has a plan of hospital stay at Dartmouth-Hitchcock Medical Center for video-EEG monitoring for standard presurgical evaluation for epilepsy.
  • Between the ages of 18 and 70 years old.
  • Patient or patient's legal guardian is able and willing to sign the informed consent prior to the ferumoxytol injection.
  • Able to undergo routine MRI.

Exclusion Criteria:

  • Absence of epileptic seizure event that is detected by video-EEG monitoring and/or by a board-certified epileptologist during the hospital stay
  • History of central nervous system conditions other than seizure, including but not limited to history of brain surgeries, cerebral vascular accidents, encephalitis or meningitis, or diagnosis of brain tumors, cerebral aneurysms, multiple sclerosis or Alzheimer's disease.
  • History of medical conditions that may influence iron metabolism, including but not limited to diagnosis of hemochromatosis, hyperbilirubinemia, hepatitis, cirrhosis or liver tumors, physical exam finding of jaundice or hepatomegaly, history of abnormal liver function test (LFT) results, or significant family history of hemochromatosis.
  • Medical history of adverse reaction to ferumoxytol
  • Pregnant or breast feeding

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): NCT02084303


Locations
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United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
American Epilepsy Society
Investigators
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Principal Investigator: Barbara C Jobst, MD Dartmouth-Hitchcock Medical Center

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Responsible Party: Barbara Jobst, Neurologist, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT02084303     History of Changes
Other Study ID Numbers: D14089
First Posted: March 11, 2014    Key Record Dates
Last Update Posted: March 14, 2018
Last Verified: March 2018
Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Ferrosoferric Oxide
Hematinics
Parenteral Nutrition Solutions
Pharmaceutical Solutions