Manganese-Enhanced Magnetic Resonance Imaging in Healthy Volunteers and People With Multiple Sclerosis
Status:
Completed
Trial end date:
2019-09-30
Target enrollment:
Participant gender:
Summary
Background:
- Contrast agents are drugs that make certain body areas or abnormalities show up better on
imaging studies, such as magnetic resonance imaging (MRI) scans. Mangafodipir is an MRI
contrast agent with manganese that has been approved for MRI scans of the liver and pancreas.
Because contrast agents with manganese have also been shown to be useful in studying problems
with the nervous system, researchers are interested in determining if mangafodipir may be
used for MRI scans of the brain or eye, two areas that often experience problems caused by
disorders that affect the nervous system, such as multiple sclerosis. However, more
information is needed on whether mangafodipir will be useful for this purpose, or how best to
use it in MRI scans of the eye and brain. To study mangafodipir more closely, researchers are
interested in studying its use in both individuals with multiple sclerosis and healthy
volunteers.
Background:
- Contrast agents are drugs that make certain body areas or abnormalities show up better on
imaging studies, such as magnetic resonance imaging (MRI) scans. Mangafodipir is an MRI
contrast agent with manganese that has been approved for MRI scans of the liver and pancreas.
Because contrast agents with manganese have also been shown to be useful in studying problems
with the nervous system, researchers are interested in determining if mangafodipir may be
used for MRI scans of the brain or eye, two areas that often experience problems caused by
disorders that affect the nervous system, such as multiple sclerosis. However, more
information is needed on whether mangafodipir will be useful for this purpose, or how best to
use it in MRI scans of the eye and brain. To study mangafodipir more closely, researchers are
interested in studying its use in both individuals with multiple sclerosis and healthy
volunteers.
Objectives:
- To evaluate the safety and effectiveness of mangafodipir in imaging studies of nerve
disorders affecting the eye and brain.
Eligibility:
- Individuals between 18 and 70 years of age who either have been diagnosed with multiple
sclerosis or are healthy volunteers.
Design:
- Participants will be screened with a physical examination, medical history, and blood
tests.
- Participants will have up to 10 outpatient visits for screening and MRI scans over a
period of up to 2 months. Participants will be divided into Eye and Brain groups, based
on which area will be studied during the scans. (Participants who have available time
may be eligible for study in both groups.)
- Participants will have an initial MRI scan as part of the screening process.
- At the first visit, participants will have a baseline MRI scan once before receiving
mangafodipir.
- Participants will have up to five MRI scans, with the following procedures:
- Eye imaging group: MRI scans will be scheduled at specific times between 2 and 48 hours
after receiving mangafodipir. Eye MRI participants will wear a dark contact lens and an
eye patch for 30 minutes before receiving mangafodipir, and leave both on for up to 8
hours. The other eye will remain uncovered.
- Brain imaging group: MRI scans will be scheduled at specific times between 48 hours and
7 days after receiving mangafodipir.
- Participants will have a follow-up MRI scan 1 month after receiving mangafodipir. This
scan is done to see how long mangafodipir may affect MRI images of the brain.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)