Enhanced MRI Imaging in Healthy Participants and Participants With Epilepsy

NCT06483061 | Recruiting Phase 2 FDA Drug

• 1 other identifier: Pro00132487
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Ferumoxytol enhanced cerebral vasculature imaging

  Comparison of MRI image acquisition quality with existing images obtained using an established imaging protocol

  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

  One injection will be used while the participant is having an MRI

Study Arms (1)

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

Drug: Ferumoxytol

Interventions

Ferumoxytol DRUG

Ferumoxytol will be injected to enhance MRI images

Also known as: Feraheme

Ferumoxytol (Feraheme)

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy controls aged 18-64.
• Patients with temporal lobe epilepsy aged 18-64 and hippocampal sclerosis demonstrated on clinical MRI scan

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alberta: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Peter S. Allen MRI Unit

Edmonton, Alberta, T6G 2R3, Canada

RECRUITING

Related Publications (10)

• 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.

  PMID: 28160356 BACKGROUND

• Vasanawala 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.

  PMID: 26890830 BACKGROUND

• Adams 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.

  PMID: 36197052 BACKGROUND

• Toth 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.

  PMID: 28434822 BACKGROUND

• Nguyen 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.

  PMID: 31638489 BACKGROUND

• Buch 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.

  PMID: 35122968 BACKGROUND

• Treit 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.

  PMID: 31819910 BACKGROUND

• Adel 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.

  PMID: 36461649 BACKGROUND

• Blumcke 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.

  PMID: 17221203 BACKGROUND

• Blumcke 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.

  PMID: 23692496 BACKGROUND

MeSH Terms

Conditions

Epilepsy, Temporal Lobe

Interventions

Ferrosoferric Oxide

Condition Hierarchy (Ancestors)

Epilepsies, Partial; Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epileptic Syndromes

Intervention Hierarchy (Ancestors)

Ferric Compounds; Iron Compounds; Inorganic Chemicals; Ferrous Compounds; Minerals

Study Officials

• Donald Gross, MD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sandy Arcand

CONTACT

7809109585; sarcand@ualberta.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2024
• First Posted: July 1, 2024
• Study Start: May 1, 2025
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2029
• Last Updated: May 6, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)