Can a special MRI spot seizure hotspots in the brain?
NCT ID NCT02531880
First seen Jun 27, 2026 · Last updated Sep 17, 2026 · Updated 17 times
Summary
This early-stage study is testing whether a contrast agent called mangafodipir can safely highlight areas where the blood-brain barrier is broken in people with drug-resistant epilepsy. Forty adults will undergo MRI scans with mangafodipir and gadolinium to see if these scans can pinpoint the brain region where seizures start. The goal is to improve understanding of epilepsy, not to treat it directly.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Mangafodipir and gadolinium (contrast agents for MRI)
- What this could lead to
- If successful, this could lead to a new way to identify seizure-causing brain areas using MRI, potentially improving surgical planning for epilepsy.
- What could go wrong
- This is a very early phase 1 safety and imaging study with only 40 participants. It is not designed to test treatment effects, and the imaging technique may not prove useful in practice.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2024
- Expected to finish
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Jul 2030
An estimate. End dates often move.
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* INCLUSION CRITERIA: * Age 18-60. * Able to give written informed consent directly. * Drug resistant epilepsy participants will be defined as having clinically documented seizures with consistent EEG evidence as defined by the 1981 International Classification of Epileptic Seizures, refractory to standard anti-seizure treatment for at least one year prior to enrolling in this study and with an average of at least one seizure per month. This criterion will be established by preliminary screening NINDS Epilepsy Service under protocol 18-N-0066. Seizure focus localization will be determined by standard clinical, neurophysiologic, and imaging studies. Prior or concurrent enrollment in 18-N-0066 is required. EXCLUSION CRITERIA: General exclusions: * Patients with epilepsy who are not surgical candidates * Significant structural brain abnormality such as a brain tumor, stroke, brain damage from head trauma or blood vessel abnormalities, on the baseline MRI scan. * Positive test for HIV * Pregnancy or breast-feeding * Claustrophobia to a degree that the subject would feel uncomfortable in the MRI machine. * Cannot lie on their back for at least two hours. * Risk for MRI scan, (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, or history of being a welder or metal worker due to small metal fragments in the eye) * Unwilling to allow sharing and/or use in future studies of coded data that are collected for this study MEMRI component specific exclusions (applicable only to patients participating in this arm of the study): * History of post-ictal psychosis or post-ictal aggression * Planning to get pregnant in the next 2 months * History of clinically significant liver or kidney disease that could potentially increase the risk of CNS damage due to manganese exposure * A history of drug or alcohol abuse/dependence (subjects scoring 8 or higher on the AUDIT scale) * Screening lab abnormalities demonstrating values more than 2 times the upper limit of normal for AST, ALT, bilirubin, alkaline phosphatase, BUN, creatinine * Previous presumed occupational exposure to manganese (i.e., having worked in a mine, foundry, smelter, dry cell battery manufacturing facility, or agriculture) * Allergy to manganese * On-going treatment with calcium-channel blocker * Iron-deficiency anemia * Personal history of Parkinson s Disease or Parkinsonism or presence of this disease in a 1st degree relative Gadolinium enhanced MRI component specific exclusions (applicable only to patients participating in this arm of the study): * Estimated GFR \<60, tested within 1 week of scan * Allergy to gadolinium Of note, patients who are ineligible for one arm of the study may still be eligible for and participate in the other arm of the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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National Institutes of Health Clinical Center
RECRUITINGBethesda, Maryland, 20892, United States
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