Epilepsy, Temporal LobePhase 2NCT06483061
Enhanced MRI Imaging in Healthy Participants and Participants With Epilepsy
A Phase 2 study testing Ferumoxytol in people with Epilepsy, Temporal Lobe, run by University of Alberta at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Epilepsy, Temporal Lobe
- What is being tested?
- Ferumoxytol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 1 May 2025to 1 Sep 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy controls aged 18-64.
- Patients with temporal lobe epilepsy aged 18-64 and hippocampal sclerosis demonstrated on clinical MRI scan
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Peter S. Allen MRI Unit
Edmonton, Alberta, T6G 2R3
Sandy Arcand, 7809109585, sarcand@ualberta.ca
Donald Gross, MD
About this study
Official title: Ferumoxytol Enhanced Hippocampal Vascular Imaging in Epilepsy
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.
Read the detailed description
Hippocampal sclerosis is the most common pathological finding in temporal lobe epilepsy.
While CA1 and CA4 subregions are typically affected, considerable variability in the involvement of the different subregions has been recognized between patients with specific hippocampal subfield pathology being demonstrated to predict surgical outcomes in medically refractory patients. Developing novel imaging biomarkers for hippocampal subfield pathology that can be obtained in vivo has the potential to allow more accurate prediction of surgical outcomes prior to surgery.
A major challenge in studying hippocampal subregions is the small size of the structures which are often smaller than the resolution of conventional MRI techniques. Cerebral blood vessels can be visualized with MRI using a variety of methods, some which do not require MRI contrast and others that do. The advantage of non-contrast methods is that subjects do not require intravenous contrast injections while the disadvantage is that the non-contrast methods are not capable of visualizing smaller vessels.
Recently high-resolution vascular imaging of the hippocampus using ferumoxytol as an MRI contrast agent has been reported by researchers at Wayne State University. It is believed that this method would provide the detail required to address the hypothesis that the microvasculature of hippocampal subregions is disrupted in temporal lobe epilepsy.
OBJECTIVES
The Specific Aims of this study are:
Aim 1: Implement ferumoxytol enhanced MRI imaging of cerebral vasculature with similar quality as compared to work conducted at Wayne State University. Aim 2: Compare hippocampal microvasculature density of hippocampal subregions between participants with TLE and hippocampal sclerosis and control subjects.
HYPOTHESES
- Successful acquisition of susceptibility weighted imaging (SWI) vascular imaging, with similar quality as compared to work conducted at Wayne State University, will be possible.
- Participants with temporal lobe epilepsy and hippocampal sclerosis will demonstrate reduced microvasculature in hippocampal subfields that will correlate with previously reported regional MRI changes.
METHODS /DATA ANALYSIS
AIM 1:
10 control subjects will be scanned using the Wayne State University SWI acquisition protocol. Participants will receive ferumoxytol diluted with normal saline administered by a Registered Nurse using an MRI compatible IV infusion pump. Any adverse events during the infusion / scan will be documented and compared to previous ferumoxytol MRI safety data. Data quality will be assessed both qualitatively and quantitatively. Maps of the hippocampal microvasculature will be obtained and reviewed in order to confirm that the quality of the maps is comparable to the Wayne State University data. Fractional vessel density (FVD) of microvasculature, major arteries and major veins will be obtained, and comparisons will be made to ensure that the mean values and standard deviations are comparable.
AIM 2:
20 control subjects, and 20 participants with temporal lobe epilepsy and hippocampal sclerosis, will be studied. Participants will receive ferumoxytol diluted with normal saline administered by a Registered Nurse using a MRI compatible IV infusion pump. Any adverse events will be documented.
Microvasculature density of hippocampal subregions will be evaluated based on the same image analysis approach as the Wayne State University Group.
- Conditions
- Epilepsy, Temporal Lobe
- Being tested
- Ferumoxytol
- Medical subject headings
- Epilepsy, Temporal Lobe
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FerumoxytolDrug
Also called Feraheme
Ferumoxytol will be injected to enhance MRI images
| Study group | Role | What they receive |
|---|---|---|
| Ferumoxytol (Feraheme) | Experimental | 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 Receives: Drug: Ferumoxytol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ferumoxytol enhanced cerebral vasculature imaging
Comparison of MRI image acquisition quality with existing images obtained using an established imaging protocol
Measured: One injection will be used while the participant is having an MRI
Ferumoxytol enhanced cerebral vasculature imaging
Comparison of microvasculature density of hippocampal subregions between participants with TLE and hippocampal sclerosis and control subjects
Measured: One injection will be used while the participant is having an MRI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2024
- Study start1 May 2025
- Primary completion1 Sep 2029 (estimated)
- Study completion1 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Epilepsy, Temporal LobeStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Donald Gross, MD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06483061
- Sponsor's protocol ID
- Pro00132487
- Status last verified
- May 2026
- First submitted
- 25 Jun 2024
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Finn JP, Nguyen KL, Hu P. Ferumoxytol vs. Gadolinium agents for contrast-enhanced MRI: Thoughts on evolving indications, risks, and benefits. J Magn Reson Imaging. 2017 Sep;46(3):919-923. doi: 10.1002/jmri.25580. Epub 2017 Feb 3. No abstract available.
PubMed 28160356Vasanawala SS, Nguyen KL, Hope MD, Bridges MD, Hope TA, Reeder SB, Bashir MR. Safety and technique of ferumoxytol administration for MRI. Magn Reson Med. 2016 May;75(5):2107-11. doi: 10.1002/mrm.26151. Epub 2016 Feb 18.
PubMed 26890830Adams LC, Jayapal P, Ramasamy SK, Morakote W, Yeom K, Baratto L, Daldrup-Link HE. Ferumoxytol-Enhanced MRI in Children and Young Adults: State of the Art. AJR Am J Roentgenol. 2023 Apr;220(4):590-603. doi: 10.2214/AJR.22.28453. Epub 2022 Oct 5.
PubMed 36197052Toth GB, Varallyay CG, Horvath A, Bashir MR, Choyke PL, Daldrup-Link HE, Dosa E, Finn JP, Gahramanov S, Harisinghani M, Macdougall I, Neuwelt A, Vasanawala SS, Ambady P, Barajas R, Cetas JS, Ciporen J, DeLoughery TJ, Doolittle ND, Fu R, Grinstead J, Guimaraes AR, Hamilton BE, Li X, McConnell HL, Muldoon LL, Nesbit G, Netto JP, Petterson D, Rooney WD, Schwartz D, Szidonya L, Neuwelt EA. Current and potential imaging applications of ferumoxytol for magnetic resonance imaging. Kidney Int. 2017 Jul;92(1):47-66. doi: 10.1016/j.kint.2016.12.037. Epub 2017 Apr 20.
PubMed 28434822Nguyen KL, Yoshida T, Kathuria-Prakash N, Zaki IH, Varallyay CG, Semple SI, Saouaf R, Rigsby CK, Stoumpos S, Whitehead KK, Griffin LM, Saloner D, Hope MD, Prince MR, Fogel MA, Schiebler ML, Roditi GH, Radjenovic A, Newby DE, Neuwelt EA, Bashir MR, Hu P, Finn JP. Multicenter Safety and Practice for Off-Label Diagnostic Use of Ferumoxytol in MRI. Radiology. 2019 Dec;293(3):554-564. doi: 10.1148/radiol.2019190477. Epub 2019 Oct 22.
PubMed 31638489Buch S, Chen Y, Jella P, Ge Y, Haacke EM. Vascular mapping of the human hippocampus using Ferumoxytol-enhanced MRI. Neuroimage. 2022 Apr 15;250:118957. doi: 10.1016/j.neuroimage.2022.118957. Epub 2022 Feb 2.
PubMed 35122968Treit S, Little G, Steve T, Nowacki T, Schmitt L, Wheatley BM, Beaulieu C, Gross DW. Regional hippocampal diffusion abnormalities associated with subfield-specific pathology in temporal lobe epilepsy. Epilepsia Open. 2019 Sep 13;4(4):544-554. doi: 10.1002/epi4.12357. eCollection 2019 Dec.
PubMed 31819910Adel SAA, Treit S, Abd Wahab W, Little G, Schmitt L, Wilman AH, Beaulieu C, Gross DW. Longitudinal hippocampal diffusion-weighted imaging and T2 relaxometry demonstrate regional abnormalities which are stable and predict subfield pathology in temporal lobe epilepsy. Epilepsia Open. 2023 Mar;8(1):100-112. doi: 10.1002/epi4.12679. Epub 2022 Dec 11.
PubMed 36461649Blumcke I, Pauli E, Clusmann H, Schramm J, Becker A, Elger C, Merschhemke M, Meencke HJ, Lehmann T, von Deimling A, Scheiwe C, Zentner J, Volk B, Romstock J, Stefan H, Hildebrandt M. A new clinico-pathological classification system for mesial temporal sclerosis. Acta Neuropathol. 2007 Mar;113(3):235-44. doi: 10.1007/s00401-006-0187-0. Epub 2007 Jan 13.
PubMed 17221203Blumcke I, Thom M, Aronica E, Armstrong DD, Bartolomei F, Bernasconi A, Bernasconi N, Bien CG, Cendes F, Coras R, Cross JH, Jacques TS, Kahane P, Mathern GW, Miyata H, Moshe SL, Oz B, Ozkara C, Perucca E, Sisodiya S, Wiebe S, Spreafico R. International consensus classification of hippocampal sclerosis in temporal lobe epilepsy: a Task Force report from the ILAE Commission on Diagnostic Methods. Epilepsia. 2013 Jul;54(7):1315-29. doi: 10.1111/epi.12220. Epub 2013 May 20.
PubMed 23692496
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ferumoxytol Enhanced Hippocampal Vascular Imaging in Epilepsy
- ClinicalTrials.gov ID
- NCT06483061
- Acronym / sponsor ID
- Pro00132487
- Conditions
- Epilepsy, Temporal Lobe
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 Sep 2029 (estimated)
- Study completion
- 1 Sep 2029 (estimated)
- First posted
- 1 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Hippocampal sclerosis is the most common pathological finding in temporal lobe epilepsy.
While CA1 and CA4 subregions are typically affected, considerable variability in the involvement of the different subregions has been recognized between patients with specific hippocampal subfield pathology being demonstrated to predict surgical outcomes in medically refractory patients. Developing novel imaging biomarkers for hippocampal subfield pathology that can be obtained in vivo has the potential to allow more accurate prediction of surgical outcomes prior to surgery.
A major challenge in studying hippocampal subregions is the small size of the structures which are often smaller than the resolution of conventional MRI techniques. Cerebral blood vessels can be visualized with MRI using a variety of methods, some which do not require MRI contrast and others that do. The advantage of non-contrast methods is that subjects do not require intravenous contrast injections while the disadvantage is that the non-contrast methods are not capable of visualizing smaller vessels.
Recently high-resolution vascular imaging of the hippocampus using ferumoxytol as an MRI contrast agent has been reported by researchers at Wayne State University. It is believed that this method would provide the detail required to address the hypothesis that the microvasculature of hippocampal subregions is disrupted in temporal lobe epilepsy.
OBJECTIVES
The Specific Aims of this study are:
Aim 1: Implement ferumoxytol enhanced MRI imaging of cerebral vasculature with similar quality as compared to work conducted at Wayne State University. Aim 2: Compare hippocampal microvasculature density of hippocampal subregions between participants with TLE and hippocampal sclerosis and control subjects.
HYPOTHESES
- Successful acquisition of susceptibility weighted imaging (SWI) vascular imaging, with similar quality as compared to work conducted at Wayne State University, will be possible.
- Participants with temporal lobe epilepsy and hippocampal sclerosis will demonstrate reduced microvasculature in hippocampal subfields that will correlate with previously reported regional MRI changes.
METHODS /DATA ANALYSIS
AIM 1:
10 control subjects will be scanned using the Wayne State University SWI acquisition protocol. Participants will receive ferumoxytol diluted with normal saline administered by a Registered Nurse using an MRI compatible IV infusion pump. Any adverse events during the infusion / scan will be documented and compared to previous ferumoxytol MRI safety data. Data quality will be assessed both qualitatively and quantitatively. Maps of the hippocampal microvasculature will be obtained and reviewed in order to confirm that the quality of the maps is comparable to the Wayne State University data. Fractional vessel density (FVD) of microvasculature, major arteries and major veins will be obtained, and comparisons will be made to ensure that the mean values and standard deviations are comparable.
AIM 2:
20 control subjects, and 20 participants with temporal lobe epilepsy and hippocampal sclerosis, will be studied. Participants will receive ferumoxytol diluted with normal saline administered by a Registered Nurse using a MRI compatible IV infusion pump. Any adverse events will be documented.
Microvasculature density of hippocampal subregions will be evaluated based on the same image analysis approach as the Wayne State University Group.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ferumoxytol (Feraheme) | Experimental | Drug: FerumoxytolEach 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 |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy controls aged 18-64.
- Patients with temporal lobe epilepsy aged 18-64 and hippocampal sclerosis demonstrated on clinical MRI scan
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FerumoxytolAlso: FerahemeFerumoxytol will be injected to enhance MRI images | Drug | Ferumoxytol (Feraheme) |
Primary outcome
Ferumoxytol enhanced cerebral vasculature imaging
Time frame: 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
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Background: PubMed 28160356Finn JP, Nguyen KL, Hu P. Ferumoxytol vs. Gadolinium agents for contrast-enhanced MRI: Thoughts on evolving indications, risks, and benefits. J Magn Reson Imaging. 2017 Sep;46(3):919-923. doi: 10.1002/jmri.25580. Epub 2017 Feb 3. No abstract available.
- Background: PubMed 26890830Vasanawala SS, Nguyen KL, Hope MD, Bridges MD, Hope TA, Reeder SB, Bashir MR. Safety and technique of ferumoxytol administration for MRI. Magn Reson Med. 2016 May;75(5):2107-11. doi: 10.1002/mrm.26151. Epub 2016 Feb 18.
- Background: PubMed 36197052Adams LC, Jayapal P, Ramasamy SK, Morakote W, Yeom K, Baratto L, Daldrup-Link HE. Ferumoxytol-Enhanced MRI in Children and Young Adults: State of the Art. AJR Am J Roentgenol. 2023 Apr;220(4):590-603. doi: 10.2214/AJR.22.28453. Epub 2022 Oct 5.
- Background: PubMed 28434822Toth GB, Varallyay CG, Horvath A, Bashir MR, Choyke PL, Daldrup-Link HE, Dosa E, Finn JP, Gahramanov S, Harisinghani M, Macdougall I, Neuwelt A, Vasanawala SS, Ambady P, Barajas R, Cetas JS, Ciporen J, DeLoughery TJ, Doolittle ND, Fu R, Grinstead J, Guimaraes AR, Hamilton BE, Li X, McConnell HL, Muldoon LL, Nesbit G, Netto JP, Petterson D, Rooney WD, Schwartz D, Szidonya L, Neuwelt EA. Current and potential imaging applications of ferumoxytol for magnetic resonance imaging. Kidney Int. 2017 Jul;92(1):47-66. doi: 10.1016/j.kint.2016.12.037. Epub 2017 Apr 20.
- Background: PubMed 31638489Nguyen KL, Yoshida T, Kathuria-Prakash N, Zaki IH, Varallyay CG, Semple SI, Saouaf R, Rigsby CK, Stoumpos S, Whitehead KK, Griffin LM, Saloner D, Hope MD, Prince MR, Fogel MA, Schiebler ML, Roditi GH, Radjenovic A, Newby DE, Neuwelt EA, Bashir MR, Hu P, Finn JP. Multicenter Safety and Practice for Off-Label Diagnostic Use of Ferumoxytol in MRI. Radiology. 2019 Dec;293(3):554-564. doi: 10.1148/radiol.2019190477. Epub 2019 Oct 22.
- Background: PubMed 35122968Buch S, Chen Y, Jella P, Ge Y, Haacke EM. Vascular mapping of the human hippocampus using Ferumoxytol-enhanced MRI. Neuroimage. 2022 Apr 15;250:118957. doi: 10.1016/j.neuroimage.2022.118957. Epub 2022 Feb 2.
- Background: PubMed 31819910Treit S, Little G, Steve T, Nowacki T, Schmitt L, Wheatley BM, Beaulieu C, Gross DW. Regional hippocampal diffusion abnormalities associated with subfield-specific pathology in temporal lobe epilepsy. Epilepsia Open. 2019 Sep 13;4(4):544-554. doi: 10.1002/epi4.12357. eCollection 2019 Dec.
- Background: PubMed 36461649Adel SAA, Treit S, Abd Wahab W, Little G, Schmitt L, Wilman AH, Beaulieu C, Gross DW. Longitudinal hippocampal diffusion-weighted imaging and T2 relaxometry demonstrate regional abnormalities which are stable and predict subfield pathology in temporal lobe epilepsy. Epilepsia Open. 2023 Mar;8(1):100-112. doi: 10.1002/epi4.12679. Epub 2022 Dec 11.
- Background: PubMed 17221203Blumcke I, Pauli E, Clusmann H, Schramm J, Becker A, Elger C, Merschhemke M, Meencke HJ, Lehmann T, von Deimling A, Scheiwe C, Zentner J, Volk B, Romstock J, Stefan H, Hildebrandt M. A new clinico-pathological classification system for mesial temporal sclerosis. Acta Neuropathol. 2007 Mar;113(3):235-44. doi: 10.1007/s00401-006-0187-0. Epub 2007 Jan 13.
- Background: PubMed 23692496Blumcke I, Thom M, Aronica E, Armstrong DD, Bartolomei F, Bernasconi A, Bernasconi N, Bien CG, Cendes F, Coras R, Cross JH, Jacques TS, Kahane P, Mathern GW, Miyata H, Moshe SL, Oz B, Ozkara C, Perucca E, Sisodiya S, Wiebe S, Spreafico R. International consensus classification of hippocampal sclerosis in temporal lobe epilepsy: a Task Force report from the ILAE Commission on Diagnostic Methods. Epilepsia. 2013 Jul;54(7):1315-29. doi: 10.1111/epi.12220. Epub 2013 May 20.
- Individual participant dataSharing planned: No
Related trials for Epilepsy, Temporal Lobe
RecruitingPhase 1
A Phase I Clinical Trial of UX-GIP001 in the Treatment of Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy
Epilepsy
RecruitingPhase 3
Study of NRTX-1001 Neural Cell Therapy in Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy (EPIC (EPIlepsy Cell Therapy))
Mesial Temporal Lobe Epilepsy
RecruitingObservational study
Surgery as a Treatment for Medically Intractable Epilepsy
Epilepsy, Epilepsy, Temporal Lobe
RecruitingObservational study
Investigating Epilepsy: Screening and Evaluation
Seizures, Epilepsy
Recruiting
Overnight TI in TLE
Temporal Lobe Epilepsy (TLE), Drug Resistant Epilepsy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Donald Gross, MD principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ferumoxytol in people with Epilepsy, Temporal Lobe, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sandy Arcand (7809109585, sarcand@ualberta.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ferumoxytol enhanced cerebral vasculature imaging (time frame: One injection will be used while the participant is having an MRI). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06483061, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.