Multi-Disciplinary Study: Magnetic Resonance, Histologic And Electron Microscopy Imaging Of Intravenous Superparamagnetic Crystalline Particles (Ferumoxytol) In CNS Inflammation
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 255
- 试验地点
- 1
- 主要终点
- Internal Morphology of Lesions
研究概览
简要总结
This exploratory study utilizes ferumoxytol, an iron oxide nanoparticle MR contrast agent for imaging various inflammatory processes in the head and neck region, spine, including the central nervous system. The protocol enrolls subjects with radiological or histological diagnosis of unknown, dural, or parenchymal CNS lesions, multiple sclerosis, TIA or stroke, vasculitis, or other vascular lesions; arterial vasculopathy and venous thrombosis; or enlarged cervical lymph nodes. The main purpose of this study is to better understand the underlying cellular mechanisms, contrast agent extravasation, uptake into macrophages and to assess its value in clinical MR imaging.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must have a clinical, radiological or established histological diagnosis of dural or central nervous system (CNS) parenchymal based inflammatory, vascular or demyelinating lesions, radiological suspected diagnosis of vascular CNS lesions such as ischemic stroke, TIA with suspected carotid embolic origin, or vasculopathy involving the carotids (including diagnosed carotid stenosis >50%), the aorta, the arteries of the extremities, or diagnosed thrombosis of the intraabdominal, pelvic or extremity veins, or clinical or radiological diagnosis of enlarged cervical lymph nodes in which inflammatory processes (reactive lymph nodes) is part of the differentials.
- •Subjects must be 18 years or older
- •Subjects will be followed for at least 1 month after the infusion of ferumoxytol.
- •All subjects or their authorized representative must sign a written informed consent and give HIPAA authorization in accordance with institutional guidelines.
- •Female subjects of child-bearing potential must be postmenopausal, surgically sterile, or using a reliable form of contraception for at least a month. These criteria can be waved at the discretion of the investigator if the one-month wait required is not in the best interest of the patient.
- •Karnofsky must be 30% or greater
排除标准
- •Subjects with clinically significant signs of uncal herniation
- •Subjects who have a contraindication for MRI: metal in their bodies (a cardiac pacemaker or other incompatible device), are severely agitated, or have an allergy to Gd contrast material.
- •Subjects with known allergic or hypersensitivity reactions to parenteral iron, parenteral dextran, parenteral iron-dextran, or parenteral iron-polysaccharide preparations
- •Subjects with known hepatic insufficiency or cirrhosis
- •Subjects with known or suspected iron overload
- •HIV-positive subjects on combination anti-retroviral therapy are ineligible because of the potential for pharmacokinetic interactions with ferumoxytol
- •Pregnant or lactating women are excluded from this study because of possible risk to the fetus or infant.
研究组 & 干预措施
Inflammatory lesions
Subjects with dural, central nervous system (CNS) parenchymal based inflammatory, vascular or demyelinating lesions.
干预措施: Ferumoxytol (Drug)
Vascular lesions
subjects will include those with vascular CNS lesions such as ischemic stroke, transient ischemic attack (TIA) with suspected carotid embolic origin, or vasculopathy involving the carotids, (including diagnosed carotid stenosis >50%) the aorta, or the arteries of the extremities, or diagnosed thrombosis of the intraabdominal, pelvic or extremity veins.
干预措施: Ferumoxytol (Drug)
Lymph nodes
Subjects with enlarged cervical lymph nodes in which inflammatory processes (reactive lymph nodes) is part of the differentials.
干预措施: Ferumoxytol (Drug)
结局指标
主要结局
Internal Morphology of Lesions
时间窗: 72hrs
The scoring parameters were: (1=poor, 2=moderate, 3=good).
Assessment of Border Delineation
时间窗: 72hrs
The scoring parameters were: (1=none, 2=moderate, 3=good, 4=excellent).
Number of Lesions
时间窗: 72 hours
Degree of Contrast Enhancement
时间窗: 72 hours
Scoring system for parameters: Degree of contrast enhancement (1=none, 2=moderate, 3=good, 4=excellent)
次要结局
- Ferumoxytol Particles With Histology and Electron Microscopy in Biopsy Samples(72 hours)
- Iron Uptake and Clearance in Abdominal Organs, Such as the Liver, Spleen, Pancreas and Bone Marrow by Applying Usual Abdominal MR Sequences at Multiple Time Points(6 months)
- Side Effects/Safety of Ferumoxytol When Given During MRI.(30 days)
研究者
Edward Neuwelt
Professor
Oregon Health and Science University