CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 17 enrolled
Drug / intervention
Mangafodipir (Teslascan)drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01326715
NCT01326715Phase 1Completed

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

National Institute of Neurological Disorders and Stroke (NINDS)·interventional·Posted Mar 31, 2011·Updated Sep 16, 2022

In Brief

A Phase 1 clinical trial evaluating Mangafodipir (Teslascan) for Multiple Sclerosis. Completed, enrolled 17 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 31, 2011
Enrollment StartOct 17, 2013
Primary CompletionSep 18, 2019
Study CompletionSep 13, 2022
TodayJul 2, 2026
Enrollment to primary: 5.9 yearsPosted 15.3 years ago

Interventions

Mangafodipir (Teslascan)drug

gadolinium enhancement on contrast enhanced brain MRI.