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Clinical Trials in Canada / NCT06483061
Recruiting Phase 2

Enhanced MRI Imaging in Healthy Participants and Participants With Epilepsy

NCT06483061 · tracked via the Priya Life Science Canada tracker
Sponsor
University of Alberta
Phase
Phase 2
Started
2025-05-01
Last updated
2026-05-08

Condition(s) studied

Epilepsy, Temporal Lobe

Investigational drug(s) / intervention(s)

Ferumoxytol →

Ferumoxytol: Ferumoxytol will be injected to enhance MRI images

Study summary

Temporal lobe epilepsy (TLE) is a common type of epilepsy and one of the most likely to not be controlled by medication. For patients who do not respond to medication, surgery can result in a cure of seizures. Given the fact that around 50% of patients who undergo surgery are seizure free at 10 years there is a need to improve the understanding of what factors best predict surgical outcomes in order to improve our ability to select candidates for surgery.

The demonstration of abnormalities in the temporal lobe on MRI is one of the best predictors of seizure free surgical outcomes. Recent studies suggest that changes in specific subregions of the hippocampus could be the strongest predictors of surgical success, however the small size of these regions, (millimeters) make them very difficult to study with standard clinical MRI.

Recently new MRI methods have been developed at Wayne State University to image hippocampal blood vessels using ferumoxytol infusion. Feraheme (ferumoxytol) is a drug that is approved in the United States for the treatment of iron deficiency anemia and is currently being studied as an MRI contrast agent in 8 active clinical trials in the United States as well as a Parkinson's Disease study in Canada.

Eligibility

Sex
ALL
Min age
18 Years
Max age
64 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Healthy controls aged 18-64. * Patients with temporal lobe epilepsy aged 18-64 and hippocampal sclerosis demonstrated on clinical MRI scan Exclusion Criteria: * Non-English speaking participants will be excluded as we cannot provide translation services. * Inability to provide informed consent. * Contraindications to MRI Age \< 17 years / \>65 years * Weight \> 127.5kg (which is the maximum weight of which a single 510mg vial of Ferumoxytol would accommodate a 4mg/kg dose). * Women of childbearing capacity with a positive pregnancy test * Women who are actively breast feeding * Contraindication of Ferumoxytol -known hypersensitivity to Feraheme or any of its components -History of allergic reaction to any intravenous iron product

Primary outcome measure(s)

  • Ferumoxytol enhanced cerebral vasculature imaging — One injection will be used while the participant is having an MRI
    Comparison of MRI image acquisition quality with existing images obtained using an established imaging protocol
  • Ferumoxytol enhanced cerebral vasculature imaging — One injection will be used while the participant is having an MRI
    Comparison of microvasculature density of hippocampal subregions between participants with TLE and hippocampal sclerosis and control subjects

Trial sites (1)

FacilityCityRegionStatus
Peter S. Allen MRI Unit Edmonton Alberta Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06483061 on ClinicalTrials.gov ↗ ← All trials in Canada