Investigation of Blood-Brain-Barrier Breakdown Using Manganese Magnetic Resonance Imaging in Drug-Resistant Epilepsy
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|ClinicalTrials.gov Identifier: NCT02531880|
Recruitment Status : Recruiting
First Posted : August 25, 2015
Last Update Posted : July 12, 2019
- The blood-brain barrier separates the brain from the rest of the body. Epilepsy is a neurological disease that causes seizures. It can affect this barrier. Researchers think a contrast agent called mangafodipir might be better able to show areas of the brain that epilepsy affects.
- To see if mangafodipir is well tolerated and safe. To see if it can show, on an MRI, areas of the brain that epilepsy affects.
- People ages 18-60 who:
- Have epilepsy not controlled by drugs
- Are enrolled in protocol 01-N-0139
- Participants will be screened with:
- Medical history
- Physical exam
- Blood and urine tests
- Participants will have up to 6 visits in 1 3 months. Those with epilepsy will have an inpatient stay lasting 2 10 days. Visits may include:
- Video-EEG monitoring for participants with epilepsy (not for healthy volunteers)
- An IV catheter put in place: a needle guides a thin plastic tube into an arm vein.
- Getting mangafodipir through the IV.
- 5 MRI scans over a 10-day period: a magnetic field and radio waves take pictures of the brain. Participants lie on a table that slides into a metal cylinder. They are in the cylinder for 45 90 minutes, lying still for up to 10 minutes at a time. The scanner makes loud knocking sounds. Participants will get earplugs.
- A final MRI at least 2 weeks after receiving mangafodipir. Gadolinium is given through an IV catheter.
|Condition or disease||Intervention/treatment||Phase|
|Epilepsy||Drug: Mangafodipir||Phase 1|
Objective: The primary goals of this pilot study is to (1) describe the safety profile of administration of mangafodipir patients with epilepsy and (2) determine if peri-ictal administration will allow focal entry of mangafodipir through the blood-brain-barrier and manganese enhanced magnetic resonance imaging (MEMRI) visualization of seizure foci. Secondary objectives are further exploration of MEMRI properties in patients with epilepsy.
Study population: 16 patients with drug-resistant epilepsy.
Design: Screening of enrolled participants will include a medical history, physical exam, blood and urine laboratory testing. Patients will be imaged interictally with a gadolinium enhanced MRI session. The administration of mangafodipir will be done as an inpatient during long-term video EEG recording, to ensure administration in the peri-ictal period. Patients will receive a baseline MRI scan, IV mangafodipir injection and will then be serially scanned with non-contrast MRI scans.
Outcome measures: The primary outcomes are (1) description of the safety profile of mangafodipir administration in patients with epilepsy, and (2) evaluation of the difference between T1-weighted signal intensity in the brain measured after mangafodipir administration in the seizure onset zone identified by standard clinical, EEG, and imaging studies, and the homologous contralateral region.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Investigation of Blood-Brain-Barrier Breakdown Using Manganese Magnetic Resonance Imaging in Drug-Resistant Epilepsy|
|Study Start Date :||August 22, 2015|
|Estimated Primary Completion Date :||August 31, 2021|
|Estimated Study Completion Date :||August 31, 2021|
Patients will be given the study drug
A contrast agent previously approved for liver imaging with MRI, which contains manganese.
- description of the safety profiIe of mangafodipir administration in patients with epiIepsy [ Time Frame: after mangafodipir administration ]safety profile
- evaluation of the difference between T1-weighted signal intensity in the brain measured after mangafodipir administration in the seizure onset zone identified by standard clinical, EEG, and imaging studies, and the homologous contralateral regio... [ Time Frame: after mangafodipir administration ]evaluation of the difference between T1-weighted signal intensity in the brain measured after mangafodipir administration in the seizure onset zone identified by standard clinical, EEG, and imaging studies, and the homologous contralateral region.
- MEMRI Comparison of MEMRI localization with standard presurgical localization. [ Time Frame: ongoing ]MEMRI
- DSC/DCE MRI-Permeability parameters (Ktrans, K2) in homologous brain regions. [ Time Frame: ongoing ]DSC/DCE MRI
- DSC/DCE MRI Comparison between permeability measures and presurgical localization. [ Time Frame: ongoing ]DSC/DCE MRI
- MEMRI-Spatiotemporal evolution of enhancement over scans at baseline and days 0-35. [ Time Frame: baseline, days 0-35 ]MEMR
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02531880
|Contact: Aaliyah H Hamidullah-Thiam||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 email@example.com|
|Principal Investigator:||Sara K Inati, M.D.||National Institute of Neurological Disorders and Stroke (NINDS)|