Actively Recruiting

Phase 2
Age: 18Years - 64Years
All Genders
Healthy Volunteers
ID06483061

Ferumoxytol Enhanced Hippocampal Vascular Imaging in Epilepsy

Led by University of Alberta · Updated on 2026-05-08

50

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University of Alberta

Lead Sponsor

C

Canadian Institutes of Health Research (CIHR)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Temporal lobe epilepsy (TLE) is a common form of epilepsy that often does not respond to medication. Surgery can potentially cure seizures for some patients, but only about 50% remain seizure-free after 10 years. This research aims to better understand which factors predict surgical success, focusing on detailed imaging of tiny regions in the hippocampus, a brain area affected in TLE. New MRI techniques using a drug called ferumoxytol are being studied to improve imaging of small blood vessels in these hippocampal areas. Participants will receive ferumoxytol (Feraheme), an iron-based contrast agent approved for anemia treatment and now being tested to enhance MRI images of brain vessels. The study involves administering ferumoxytol diluted with saline via an IV pump during MRI scans. The first phase includes scanning healthy control subjects to match imaging quality from previous studies. The second phase compares the hippocampal microvasculature between control subjects and patients with TLE and hippocampal sclerosis using the same imaging method. Participants will undergo MRI scans while receiving one injection of ferumoxytol. Researchers will evaluate the quality of vascular images and measure vessel density in hippocampal subregions. Safety during infusion and scanning will be monitored closely. The study includes adults aged 18 to 64, both healthy and those with TLE. The main outcome is the enhanced imaging of cerebral vasculature using ferumoxytol during MRI. Participant involvement lasts for the duration of the scan and infusion procedure.

CONDITIONS

Brief Title

Enhanced MRI Imaging in Healthy Participants and Participants With Epilepsy

Who Can Participate

Age: 18Years - 64Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Healthy controls aged 18 to 64 years
  • Patients aged 18 to 64 years with temporal lobe epilepsy and hippocampal sclerosis confirmed by clinical MRI scan
Not Eligible

You will not qualify if you...

  • Non-English speaking participants
  • Unable to provide informed consent
  • Contraindications to MRI
  • Age younger than 18 years or older than 65 years
  • Weight over 127.5 kg
  • Women who are pregnant or breastfeeding
  • Known hypersensitivity to ferumoxytol (Feraheme) or any intravenous iron product

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single treatment visit

Participants receive an injection of Ferumoxytol to enhance MRI images while undergoing MRI scanning to assess cerebral vasculature.

1 visit (in-person) during which the injection and MRI scan occur

Trial Site Locations

Total: 1 location

1

Peter S. Allen MRI Unit

Edmonton, Alberta, Canada, T6G 2R3

Actively Recruiting

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Research Team

S

Sandy Arcand

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Published Research Related To This Trial

Longitudinal hippocampal diffusion-weighted imaging and T2 relaxometry demonstrate regional abnormalities which are stable and predict subfield pathology in temporal lobe epilepsy.

Seyed Amir Ali Adel, Sarah Treit, Wasan Abd Wahab...

https://pubmed.ncbi.nlm.nih.gov/36461649

International consensus classification of hippocampal sclerosis in temporal lobe epilepsy: a Task Force report from the ILAE Commission on Diagnostic Methods.

Ingmar Blümcke, Maria Thom, Eleonora Aronica...

https://pubmed.ncbi.nlm.nih.gov/23692496