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NCT02084303 · ClinicalTrials.gov registry record · NA
Imaging Neuroinflammation in Epilepsy With Ferumoxytol MRI
A NA study, sponsored by Dartmouth-Hitchcock Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 10
- Enrollment target
NCT02084303 is a NA study that has completed, run by Dartmouth-Hitchcock Medical Center. The registered enrollment target is 10 participants.
The verdict
NCT02084303, a NA study, has completed, sponsored by Dartmouth-Hitchcock Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 10 participants
- Enrollment target
Study 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.
Interventions
- OTHER Ferumoxytol injection after focal epileptic seizure followed by iron-sensitive MRI
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2014-03 |
| Est. Completion | 2018-03-02 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02084303
The ClinicalTrials.gov registry entry for NCT02084303 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Dartmouth-Hitchcock Medical Center, which has 427 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Ferumoxytol injection after focal epileptic seizure followed by iron-sensitive MRI is the first listed.
NCT02084303 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02084303 about?
NCT02084303 is a clinical study titled "Imaging Neuroinflammation in Epilepsy With Ferumoxytol MRI". 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 ...
What is the current status of trial NCT02084303?
This trial is currently completed. It is a NA study. The enrollment target is 10 participants. The study started on 2014-03. Estimated completion is 2018-03-02.
What interventions are being tested in trial NCT02084303?
The interventions under investigation include: Ferumoxytol injection after focal epileptic seizure followed by iron-sensitive MRI (OTHER).
Who is sponsoring clinical trial NCT02084303?
This trial is sponsored by Dartmouth-Hitchcock Medical Center, which has 427 total clinical trials registered on ClinicalTrials.gov.
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