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NCT02511028 · ClinicalTrials.gov registry record · Phase 1
In Vivo Characterization of Inflammation With Ferumoxytol, an Ultrasmall Superparamagnetic Iron Oxide Nanoparticle, on 7 Tesla Magnetic Resonance Imaging
A Phase 1 study of Multiple Sclerosis, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Completed
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
- 1
- Study location
NCT02511028 is a Phase 1 study of Multiple Sclerosis that has completed, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 14 participants, below the 585-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02511028, a Phase 1 study of Multiple Sclerosis, has completed, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: \- Contrast agents help things show up better on magnetic resonance imaging (MRI) scans. Researchers want to see if the drug ferumoxytol is a good contrast agent. They want to determine that it does not cause prolonged MRI changes in the brain and to see if it helps identify inflammation in multiple sclerosis Objective: \- To learn how ferumoxytol can be used to image inflammation in multiple sclerosis (MS). Eligibility: * Adults ages 18 70 who have MS. * Healthy volunteers ages 18 70. Design: * Participants will have 5 clinic visits over 6 months. * Participants will be screened with a medical history, neurological exam, and blood draw. Full clinical measures will be obtained. * Participants will have a 7 tesla brain MRI scan that may include gadolinium contrast agent. The MRI is a metal cylinder in a strong magnetic field. The participant will lie on a table that can slide in and out of the cylinder. * During visit 2, ferumoxytol with be given through a catheter (a thin plastic tube) that is inserted with a needle into a vessel in the arm. \<TAB\>- Participants will then have a 7 tesla MRI scan of the brain.. * At each of the next 3 clinic visits, participants will have a 7 tesla brain MRI and have blood drawn. The MRIs may include gadolinium. * Participants may have a full neurologic exam at these visits. At the final visit, full clinical measures will be obtained. * Participants may have more MRI scans if a 6-month MRI shows ferumoxytol still in the brain.
Conditions Studied
Interventions
- DRUG Ferumoxytol
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2015-11-27 |
| Est. Completion | 2019-01-29 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02511028
The ClinicalTrials.gov registry entry for NCT02511028 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 585-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (98% lower). The listed sponsor is National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Multiple Sclerosis appearing as the primary indexed condition, and to 1 intervention - of which Ferumoxytol is the first listed.
NCT02511028 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT02511028 about?
NCT02511028 is a clinical study titled "In Vivo Characterization of Inflammation With Ferumoxytol, an Ultrasmall Superparamagnetic Iron Oxide Nanoparticle, on 7 Tesla Magnetic Resonance Imaging". Background: \- Contrast agents help things show up better on magnetic resonance imaging (MRI) scans. Researchers want to see if the drug ferumoxytol is a good contrast agent. They want to determine that it does not cause prolonged MRI changes in the brain and to see if it helps identify inflammatio...
What is the current status of trial NCT02511028?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2015-11-27. Estimated completion is 2019-01-29.
What conditions does trial NCT02511028 study?
This clinical trial studies the following conditions: Multiple Sclerosis.
What interventions are being tested in trial NCT02511028?
The interventions under investigation include: Ferumoxytol (DRUG).
Who is sponsoring clinical trial NCT02511028?
This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02511028 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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