Imaging Neuroinflammation in Epilepsy With Ferumoxytol MRI (IRONMAN)
Primary Purpose
Epilepsy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ferumoxytol injection after focal epileptic seizure followed by iron-sensitive MRI
Sponsored by
About this trial
This is an interventional diagnostic trial for Epilepsy
Eligibility 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
Sites / Locations
- Dartmouth-Hitchcock Medical Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Ferumoxytol MRI
Arm Description
Ferumoxytol injection after focal epileptic seizure followed by iron-sensitive MRI.
Outcomes
Primary Outcome Measures
Overlap of epileptogenic zone with brain regions that take up ferumoxytol
Ferumoxytol will be injected within one hour of epileptic event and iron-sensitive MRI will be conducted within 48 hours.
Secondary Outcome Measures
Immunohistochemical evidence of neuroinflammation in brain tissue that has taken up ferumoxytol
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.
Full Information
NCT ID
NCT02084303
First Posted
March 5, 2014
Last Updated
March 12, 2018
Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
American Epilepsy Society
1. Study Identification
Unique Protocol Identification Number
NCT02084303
Brief Title
Imaging Neuroinflammation in Epilepsy With Ferumoxytol MRI
Acronym
IRONMAN
Official Title
Imaging Neuroinflammation in Epilepsy With Ferumoxytol MRI
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
March 29, 2015 (Actual)
Study Completion Date
March 2, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
American Epilepsy Society
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ferumoxytol MRI
Arm Type
Other
Arm Description
Ferumoxytol injection after focal epileptic seizure followed by iron-sensitive MRI.
Intervention Type
Other
Intervention Name(s)
Ferumoxytol injection after focal epileptic seizure followed by iron-sensitive MRI
Primary Outcome Measure Information:
Title
Overlap of epileptogenic zone with brain regions that take up ferumoxytol
Description
Ferumoxytol will be injected within one hour of epileptic event and iron-sensitive MRI will be conducted within 48 hours.
Time Frame
up to 48 hours after epileptic seizure
Secondary Outcome Measure Information:
Title
Immunohistochemical evidence of neuroinflammation in brain tissue that has taken up ferumoxytol
Description
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.
Time Frame
Two years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara C Jobst, MD
Organizational Affiliation
Dartmouth-Hitchcock Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Imaging Neuroinflammation in Epilepsy With Ferumoxytol MRI
We'll reach out to this number within 24 hrs