NCT06483061RecruitingPhase 2
Enhanced MRI Imaging in Healthy Participants and Participants With Epilepsy
Ferumoxytol Enhanced Hippocampal Vascular Imaging in Epilepsy
Source: ClinicalTrials.gov · Last updated 8 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 25 Jun 2024
- Start date
- 1 May 2025
- Primary completion date
- 1 Sept 2029
- Lead sponsor
- University of Alberta
- Diseases
- Epilepsy
- NCT number
- NCT06483061
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 50
- From 1 May 2025 to the primary completion date, 1 Sept 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Contraindication of Ferumoxytol -known hypersensitivity to Feraheme or any of its components -History of allergic reaction to any intravenous iron product
Age
- Contraindications to MRI Age \< 17 years / \>65 years
Other
- Non-English speaking participants will be excluded as we cannot provide translation services.
- Inability to provide informed consent.
- 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
Who the study is looking for
- Healthy controls aged 18-64.
- Patients with temporal lobe epilepsy aged 18-64 and hippocampal sclerosis demonstrated on clinical MRI scan
Age in the registry: 18 years to 64 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peter S. Allen MRI Unit Coordinator of this site? Confirm its status | Edmonton | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.