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临床试验/NCT06483061
NCT06483061招募中2 期

Ferumoxytol Enhanced Hippocampal Vascular Imaging in Epilepsy

University of Alberta2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年5月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
招募中
入组人数
50
试验地点
2
主要终点
Ferumoxytol enhanced cerebral vasculature imaging

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

研究组 & 干预措施

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

干预措施: Ferumoxytol (Drug)

结局指标

主要结局

Ferumoxytol enhanced cerebral vasculature imaging

时间窗: 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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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