Manganese-Enhanced Magnetic Resonance Imaging in Healthy Volunteers and People With Multiple Sclerosis
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Sclerosis Optic Neuritis |
Drug: Mangafodipir (Teslascan) |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Manganese-Enhanced Magnetic Resonance Imaging in Healthy Volunteers and People With Multiple Sclerosis |
- MRI changes after mangafodipir administration MRI changes after mangafodipir administration [ Time Frame: 1 day - 1 week ] [ Designated as safety issue: No ]
- MRI changes in the brain after mangafodipir administration [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
- Optimum scanning times [ Time Frame: 1 day - 1 week ] [ Designated as safety issue: No ]
- Correlation w/ Vision Measures [ Time Frame: 1 day - 1 week ] [ Designated as safety issue: No ]
- Assessment of lesion visualization [ Time Frame: 1 day - 1 week ] [ Designated as safety issue: No ]
- Differences in MRI Enhancement Pattern between healthy volunteers and people with MS [ Time Frame: 1 day - 1 week ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 25 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | December 2014 |
-
Drug: Mangafodipir (Teslascan)
Objective
The goals of this pilot study are to assess whether: (1) manganese-enhanced magnetic resonance imaging (MEMRI) using mangafodipir trisodium (Teslascan(Trademark)) can detect multiple sclerosis-related tissue damage in the retina, optic nerve, and brain; and (2) the MRI effects of manganese are detectable in the basal ganglia one month following administration.
Study Population
Up to 10 healthy volunteers and up to 15 participants with multiple sclerosis.
Design
The first phase of the study will involve healthy volunteers and will focus on optimizing our imaging protocol. The second phase will study participants with multiple sclerosis.
Outcome Measures
The primary outcome measure is T1-weighted signal intensity, measured: (1) in the retina, optic nerve, and brain at early time points after mangafodipir administration; and (2) in the basal ganglia, cerebral cortex, and whole brain one month following administration.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
- INCLUSION CRITERIA:
HEALTHY VOLUNTEER:
Age between 18 and 70
Vital signs within normal range at the time of the screening visit
Normal complete blood count and normal kidney and liver function tests
Able to give informed consent
For retinal imaging studies, corrected visual acuity of 20/30 or better
For retinal imaging studies, intraocular pressure between 11 and 19 mm Hg
Normal screening brain MRI
PATIENT:
Age between 18 and 70
Vital signs within normal range at the time of the screening visit
Normal complete blood count and normal kidney and liver function tests
Able to give informed consent
For retinal imaging studies, intraocular pressure between 11 and 19 mm Hg
Diagnosis of multiple sclerosis according to revised McDonald Criteria
Expanded disability status scale (EDSS) 0-6
EXCLUSION CRITERIA:
HEALTHY VOLUNTEER:
Reported history of systemic, ocular, or central-nervous-system disorders
Screening labs demonstrating any value for hepatic or biliary function out of the range of normal, to include AST, ALT, bilirubin, gammaGT, alkaline phosphatase
Previous or current alcohol and/or substance abuse
Previous presumed occupational exposure to manganese (i.e., having worked in a mine, foundry, smelter, dry cell battery manufacturing facility, or agriculture)
Medical contraindications for MRI (e.g., any non-organic implant or other device such as a cardiac pacemaker or infusion pump or other metallic implants, objects or body piercings that cannot be removed)
Psychological contraindications for MRI (e.g., claustrophobia), to be assessed at the time the medical history is collected
Pregnancy or current breastfeeding
Allergy to manganese
Reported history of impaired hearing, because people with impaired hearing are at increased risk of sound-induced damage from the MRI scanner
Family history of Parkinson's Disease or other neurodegenerative disease
Ongoing treatment with calcium-channel blockers
Iron-deficiency anemia
PATIENT:
Reported history of clinically significant medical disorders, such as liver or kidney disease, that could potentially increase the risk of CNS damage due to manganese exposure
Screening labs demonstrating any value for hepatic or biliary function out of the range of normal, to include AST, ALT, bilirubin, gammaGT, alkaline phosphatase
Reported history of ocular disorders
Previous or current alcohol and/or substance abuse
Previous presumed occupational exposure to manganese (i.e., having worked in a mine, foundry, smelter, dry cell battery manufacturing facility, or agriculture)
Medical contraindications for MRI (e.g., any non-organic implant or other device such as a cardiac pacemaker or infusion pump or other metallic implants, objects or body piercings that cannot be removed)
Psychological contraindications for MRI (e.g., claustrophobia), to be assessed at the time the medical history is collected
Pregnancy or current breastfeeding
Allergy to manganese
Reported history of impaired hearing, because people with impaired hearing are at increased risk of sound-induced damage from the MRI scanner
Greater than 1 contrast-enhancing lesion on screening MRI performed within one week of administration of mangafodipir
On-going treatment with calcium-channel blocker
Iron-deficiency anemia
Contacts and Locations| United States, Maryland | |
| National Institutes of Health Clinical Center, 9000 Rockville Pike | |
| Bethesda, Maryland, United States, 20892 | |
| Principal Investigator: | Daniel S Reich, M.D. | National Institutes of Health Clinical Center (CC) |
More Information
Additional Information:
Publications:
| Responsible Party: | National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) ) |
| ClinicalTrials.gov Identifier: | NCT01326715 History of Changes |
| Other Study ID Numbers: | 110116, 11-N-0116 |
| Study First Received: | March 30, 2011 |
| Last Updated: | May 1, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institutes of Health Clinical Center (CC):
|
Multiple Sclerosis MRI Manganese Enhanced MRI Optic Neuritis Healthy Volunteer |
Additional relevant MeSH terms:
|
Multiple Sclerosis Neuritis Optic Neuritis Sclerosis Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases Peripheral Nervous System Diseases |
Neuromuscular Diseases Optic Nerve Diseases Cranial Nerve Diseases Eye Diseases Pathologic Processes Manganese Trace Elements Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013