Improving MRI Imaging for Patients with Temporal Lobe Epilepsy
Ferumoxytol Enhanced Hippocampal Vascular Imaging in Epilepsy
This study is testing a new MRI technique using a special contrast agent to see if it can help doctors find important details in the brains of people with temporal lobe epilepsy, which might improve their chances of successful surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 64 Years |
| Sex | All |
| Sponsor | University of Alberta Academic / other |
| Locations | 1 site (Edmonton, Alberta) |
| Trial ID | NCT06483061 on ClinicalTrials.gov |
What this trial studies
This study aims to enhance MRI imaging techniques to better visualize the hippocampal subregions in patients with temporal lobe epilepsy (TLE) and healthy participants. By using ferumoxytol as a contrast agent, researchers hope to identify specific vascular abnormalities that could predict surgical outcomes for patients with TLE who are resistant to medication. The study will involve both healthy controls and patients with documented hippocampal sclerosis, focusing on the relationship between imaging biomarkers and surgical success. The goal is to improve the selection process for surgical candidates by providing more accurate imaging data.
Who should consider this trial
Good fit: Ideal candidates include healthy individuals aged 18-64 and patients with temporal lobe epilepsy aged 18-64 who have hippocampal sclerosis evident on MRI.
Not a fit: Patients outside the age range of 18-64, those with contraindications to MRI, or those who cannot provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better surgical outcomes for patients with temporal lobe epilepsy by improving the selection criteria for surgery.
How similar studies have performed: While the use of ferumoxytol for MRI imaging is a novel approach, previous studies have shown promise in enhancing imaging techniques for better surgical outcomes in epilepsy.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Edmonton, Alberta
- Peter S. Allen MRI Unit — Edmonton, Alberta, Canada (Recruiting)
Study contacts
- Principal investigator: Donald Gross, MD — University of Alberta
- Study coordinator: Sandy Arcand
- Email: sarcand@ualberta.ca
- Phone: 7809109585
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.