Investigation of Blood-Brain-Barrier Breakdown Using Manganese Magnetic Resonance Imaging in Drug-Resistant Epilepsy
Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)
This observational or N/A phase trial investigates Epilepsy and is currently actively recruiting participants. National Institute of Neurological Disorders and Stroke (NINDS) leads this study, which shows 81 recorded versions since 2024 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.
Study Description(click to expand)Objective: The primary goals of this pilot study are to (1) describe the safety profile of administration of mangafodipir in patients with epilepsy and (2) investigate the prevalence of blood-brain barrier disruption (BBBD) in patients with drug-resistant focal epilepsy using peri-ictal manganese enhanced magnetic resonance imaging (MEMRI) and interictal gadolinium dynamic contrast-enhanced MRI (DCE-MRI) and determine if these methods will allow for visualization of seizure foci. Secondary objectives are further exploration of MEMRI and DCE-MRI properties in patients with epilepsy. Study population: 40 patients with drug-resistant epilepsy. Design: Screening of enrolled participants will include a medical history, physical exam, blood and urine laboratory testing. There are two arms of this study; patients may be enrolled in either arm or both. For one arm, patients will be imaged interictally with a gadolinium enhanced MRI session (DCE-MRI). For the other arm, patients will be imaged peri-ictally with manganese enhanced MRI (MEMRI) 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...
Objective:
The primary goals of this pilot study are to (1) describe the safety profile of administration of mangafodipir in patients with epilepsy and (2) investigate the prevalence of blood-brain barrier disruption (BBBD) in patients with drug-resistant focal epilepsy using peri-ictal manganese enhanced magnetic resonance imaging (MEMRI) and interictal gadolinium dynamic contrast-enhanced MRI (DCE-MRI) and determine if these methods will allow for visualization of seizure foci. Secondary objectives are further exploration of MEMRI and DCE-MRI properties in patients with epilepsy.
Study population:
40 patients with drug-resistant epilepsy.
Design:
Screening of enrolled participants will include a medical history, physical exam, blood and urine laboratory testing. There are two arms of this study; patients may be enrolled in either arm or both. For one arm, patients will be imaged interictally with a gadolinium enhanced MRI session (DCE-MRI). For the other arm, patients will be imaged peri-ictally with manganese enhanced MRI (MEMRI) 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 utility of MEMRI and/or DCE-MRI in identifying focal BBBD in the seizure onset zone identified by standard clinical, EEG, and imaging studies, and the homologous contralateral region.
Status Flow
Change History
81 versions recorded-
May 4, 2026 — Present [daily]
Recruiting
-
Apr 28, 2026 — May 4, 2026 [daily]
Recruiting
Phase: PHASE1 → None
-
Mar 2026 — Apr 2026 [monthly]
Recruiting PHASE1
-
Feb 2026 — Mar 2026 [monthly]
Recruiting PHASE1
-
Jan 2026 — Feb 2026 [monthly]
Recruiting PHASE1
▶ Show 76 earlier versions
-
Dec 2025 — Jan 2026 [monthly]
Recruiting PHASE1
-
Nov 2025 — Dec 2025 [monthly]
Recruiting PHASE1
-
Oct 2025 — Nov 2025 [monthly]
Recruiting PHASE1
-
Sep 2025 — Oct 2025 [monthly]
Recruiting PHASE1
-
Aug 2025 — Sep 2025 [monthly]
Recruiting PHASE1
-
Jul 2025 — Aug 2025 [monthly]
Recruiting PHASE1
-
Jun 2025 — Jul 2025 [monthly]
Recruiting PHASE1
-
May 2025 — Jun 2025 [monthly]
Recruiting PHASE1
-
Apr 2025 — May 2025 [monthly]
Recruiting PHASE1
-
Mar 2025 — Apr 2025 [monthly]
Recruiting PHASE1
-
Feb 2025 — Mar 2025 [monthly]
Recruiting PHASE1
-
Jan 2025 — Feb 2025 [monthly]
Recruiting PHASE1
-
Dec 2024 — Jan 2025 [monthly]
Recruiting PHASE1
-
Nov 2024 — Dec 2024 [monthly]
Recruiting PHASE1
-
Oct 2024 — Nov 2024 [monthly]
Recruiting PHASE1
-
Sep 2024 — Oct 2024 [monthly]
Recruiting PHASE1
-
Aug 2024 — Sep 2024 [monthly]
Recruiting PHASE1
-
Jul 2024 — Aug 2024 [monthly]
Recruiting PHASE1
-
Jun 2024 — Jul 2024 [monthly]
Recruiting PHASE1
-
May 2024 — Jun 2024 [monthly]
Recruiting PHASE1
Status: Not Yet Recruiting → Recruiting
-
Apr 2024 — May 2024 [monthly]
Not Yet Recruiting PHASE1
-
Feb 2024 — Apr 2024 [monthly]
Not Yet Recruiting PHASE1
-
Jan 2024 — Feb 2024 [monthly]
Not Yet Recruiting PHASE1
-
Dec 2023 — Jan 2024 [monthly]
Not Yet Recruiting PHASE1
-
Nov 2023 — Dec 2023 [monthly]
Not Yet Recruiting PHASE1
-
Oct 2023 — Nov 2023 [monthly]
Not Yet Recruiting PHASE1
-
Sep 2023 — Oct 2023 [monthly]
Not Yet Recruiting PHASE1
-
Aug 2023 — Sep 2023 [monthly]
Not Yet Recruiting PHASE1
-
Jul 2023 — Aug 2023 [monthly]
Not Yet Recruiting PHASE1
-
Jun 2023 — Jul 2023 [monthly]
Not Yet Recruiting PHASE1
-
May 2023 — Jun 2023 [monthly]
Not Yet Recruiting PHASE1
-
Apr 2023 — May 2023 [monthly]
Not Yet Recruiting PHASE1
-
Mar 2023 — Apr 2023 [monthly]
Not Yet Recruiting PHASE1
-
Feb 2023 — Mar 2023 [monthly]
Not Yet Recruiting PHASE1
-
Jan 2023 — Feb 2023 [monthly]
Not Yet Recruiting PHASE1
-
Dec 2022 — Jan 2023 [monthly]
Not Yet Recruiting PHASE1
-
Nov 2022 — Dec 2022 [monthly]
Not Yet Recruiting PHASE1
-
Sep 2022 — Nov 2022 [monthly]
Not Yet Recruiting PHASE1
-
Jul 2022 — Sep 2022 [monthly]
Not Yet Recruiting PHASE1
-
Jun 2022 — Jul 2022 [monthly]
Not Yet Recruiting PHASE1
-
May 2022 — Jun 2022 [monthly]
Not Yet Recruiting PHASE1
-
Apr 2022 — May 2022 [monthly]
Not Yet Recruiting PHASE1
-
Jan 2022 — Apr 2022 [monthly]
Not Yet Recruiting PHASE1
-
Dec 2021 — Jan 2022 [monthly]
Not Yet Recruiting PHASE1
-
Nov 2021 — Dec 2021 [monthly]
Not Yet Recruiting PHASE1
-
Oct 2021 — Nov 2021 [monthly]
Not Yet Recruiting PHASE1
-
Sep 2021 — Oct 2021 [monthly]
Not Yet Recruiting PHASE1
-
Jun 2021 — Sep 2021 [monthly]
Not Yet Recruiting PHASE1
-
May 2021 — Jun 2021 [monthly]
Not Yet Recruiting PHASE1
-
Apr 2021 — May 2021 [monthly]
Not Yet Recruiting PHASE1
-
Mar 2021 — Apr 2021 [monthly]
Not Yet Recruiting PHASE1
-
Feb 2021 — Mar 2021 [monthly]
Not Yet Recruiting PHASE1
-
Jan 2021 — Feb 2021 [monthly]
Not Yet Recruiting PHASE1
-
Dec 2020 — Jan 2021 [monthly]
Not Yet Recruiting PHASE1
-
Nov 2020 — Dec 2020 [monthly]
Not Yet Recruiting PHASE1
-
Oct 2020 — Nov 2020 [monthly]
Not Yet Recruiting PHASE1
-
Sep 2020 — Oct 2020 [monthly]
Not Yet Recruiting PHASE1
-
Aug 2020 — Sep 2020 [monthly]
Not Yet Recruiting PHASE1
Status: Active Not Recruiting → Not Yet Recruiting
-
Jul 2020 — Aug 2020 [monthly]
Active Not Recruiting PHASE1
Status: Recruiting → Active Not Recruiting
-
Jun 2020 — Jul 2020 [monthly]
Recruiting PHASE1
-
Apr 2020 — Jun 2020 [monthly]
Recruiting PHASE1
-
Mar 2020 — Apr 2020 [monthly]
Recruiting PHASE1
-
Jan 2020 — Mar 2020 [monthly]
Recruiting PHASE1
-
Dec 2019 — Jan 2020 [monthly]
Recruiting PHASE1
-
Oct 2019 — Dec 2019 [monthly]
Recruiting PHASE1
-
Aug 2019 — Oct 2019 [monthly]
Recruiting PHASE1
-
Jul 2019 — Aug 2019 [monthly]
Recruiting PHASE1
-
Jun 2019 — Jul 2019 [monthly]
Recruiting PHASE1
-
Apr 2019 — Jun 2019 [monthly]
Recruiting PHASE1
Status: Suspended → Recruiting
-
Mar 2019 — Apr 2019 [monthly]
Suspended PHASE1
-
Feb 2019 — Mar 2019 [monthly]
Suspended PHASE1
-
Aug 2018 — Feb 2019 [monthly]
Suspended PHASE1
-
Jul 2018 — Aug 2018 [monthly]
Suspended PHASE1
-
Jun 2018 — Jul 2018 [monthly]
Suspended PHASE1
-
Feb 2017 — Jun 2018 [monthly]
Suspended PHASE1
-
Jan 2017 — Feb 2017 [monthly]
Suspended PHASE1
First recorded
Eligibility Summary
Background: \- 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. Objective: \- 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. Eligibility: * People ages 18-60 who: * Have epilepsy not controlled by drugs * Prior or concurrent enrollment in 18-N-0066 is required Design: * 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 * 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....
Contact Information
- National Institute of Neurological Disorders and Stroke (NINDS)
For direct contact, visit the study record on ClinicalTrials.gov .