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Manganese-Enhanced Magnetic Resonance Imaging in Healthy Volunteers and People With Multiple Sclerosis

This study is currently Recruiting

February 2011 By National Institutes of Health Clinical Center (CC)

First Recieved on March 30, 2011

Last Updated on May 11, 2011

Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)
Collaborators:
Information provided by: National Institutes of Health Clinical Center (CC)
Identifier: NCT01326715

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.

Study Type: Interventional
Study Design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Eligibility

Ages Eligible for Study:18 Years
Genders Eligible for Study:Both
Accepts Healthy Volunteers:Accepts Healthy Volunteers
Criteria

- 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

Investigators

Locations

  • National Institutes of Health Clinical Center, 9000 Rockville Pike

    Bethesda, Maryland 20892 United States

Conditions related to this trial:

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