Recruiting
Phase 2

Ferumoxytol

Sponsor:

University of Alberta

Code:

NCT06483061

Conditions

Epilepsy, Temporal Lobe

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Accepted

Interventions

Ferumoxytol

Study Details

Brief 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.

Conditions

Epilepsy, Temporal Lobe

Study ID

NCT06483061

Start date

May 1, 2025

Status verified date

May, 2026

Completion date

Sep 1, 2029

Anticipated

Primary completion date

Sep 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 64

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

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Ferumoxytol (Feraheme)

Each participant and control will receive Ferumoxytol (Feraheme) 4 mg/kg diluted with 60ml normal saline, administered at 150-200ml/Hr by a registered nurse using a MRI compatible IV infusion pump

Interventions

Ferumoxytol

Ferumoxytol will be injected to enhance MRI images

Primary outcome measure

  • Ferumoxytol enhanced cerebral vasculature imaging [ Time Frame: One injection will be used while the participant is having an MRI ]
  • Ferumoxytol enhanced cerebral vasculature imaging [ Time Frame: One injection will be used while the participant is having an MRI ]

Central Contacts and Locations

Central contacts

Sandy Arcand

7809109585sarcand@ualberta.ca

Locations

Peter S. Allen MRI Unit

Recruiting

Edmonton, Alberta, Canada, T6G 2R3

Contacts

Sandy Arcand

7809109585sarcand@ualberta.ca

Principal Investigator:

Donald Gross, MD

More Information

Sponsor

University of Alberta

Last update posted

May 8, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alberta on 2026-05-08.