MR Imaging of Inflammatory Responses in the Central Nervous System With Ferumoxytol-Enhanced MRI (Pediatric Brain Tumor Protocol)
试验速览
- 阶段
- 早期 1 期
- 状态
- 撤回
- 发起方
- 主要终点
- Iron concentration measurements
研究概览
简要总结
This pilot early phase I trial studies how well ferumoxytol-enhanced magnetic resonance imaging (MRI) correlates with inflammatory (macrophage) responses in pediatric patients with malignant brain tumors. If there is good correlation, ferumoxytol-enhanced MRI can serve as a noninvasive imaging biomarker of inflammation.
详细描述
PRIMARY OBJECTIVE:
I. To establish the magnetic resonance (MR) imaging signal characteristics of macrophages in pediatric patients (>= 2 years old) with newly diagnosed malignant brain tumors using ferumoxytol, an ultrasmall superparamagnetic iron oxide (USPIO) particle.
SECONDARY OBJECTIVES:
I. To correlate the MRI signal of ferumoxytol uptake in macrophages with the number of macrophages in surgical tumor specimen at histopathology.
OUTLINE:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any patient with suspected malignant brain tumor on diagnostic MR imaging who will undergo a resection
排除标准
- •Informed consent cannot be obtained either from the patient or legal representative
- •Severe coexisting or terminal systemic disease that may interfere with the conduct of the study
- •Contraindication to MRI (metal implants)
- •Hemosiderosis/hemochromatosis
- •Iron overload from any cause (not just hemosiderosis or hemochromatosis), even if secondary to frequent blood transfusions, severe chronic hemolysis, excess dietary or parenteral iron, or any other etiology
- •Known hypersensitivity to ferumoxytol or any of its components
- •Pregnant patients
研究组 & 干预措施
Diagnostic (ferumoxytol-enhanced MRI)
All subjects in the experimental arm will have a single intravenous dose of ferumoxytol (5 mg Fe/kg), to be administered 24 hours before the subject undergoes ferumoxytol-enhanced magnetic resonance imaging (MRI). These subjects will subsequently undergo surgery, and tissue analysis of surgically resected samples (specifically the number of iron-containing and non-iron-containing macrophages) will be correlated with imaging features on ferumoxytol-enhanced MRI.
干预措施: Diagnostic (ferumoxytol-enhanced MRI) (Diagnostic Test)
Diagnostic (ferumoxytol-enhanced MRI)
All subjects in the experimental arm will have a single intravenous dose of ferumoxytol (5 mg Fe/kg), to be administered 24 hours before the subject undergoes ferumoxytol-enhanced magnetic resonance imaging (MRI). These subjects will subsequently undergo surgery, and tissue analysis of surgically resected samples (specifically the number of iron-containing and non-iron-containing macrophages) will be correlated with imaging features on ferumoxytol-enhanced MRI.
干预措施: Surgery (Procedure)
Diagnostic (ferumoxytol-enhanced MRI)
All subjects in the experimental arm will have a single intravenous dose of ferumoxytol (5 mg Fe/kg), to be administered 24 hours before the subject undergoes ferumoxytol-enhanced magnetic resonance imaging (MRI). These subjects will subsequently undergo surgery, and tissue analysis of surgically resected samples (specifically the number of iron-containing and non-iron-containing macrophages) will be correlated with imaging features on ferumoxytol-enhanced MRI.
干预措施: Ferumoxytol (Drug)
Diagnostic (ferumoxytol-enhanced MRI)
All subjects in the experimental arm will have a single intravenous dose of ferumoxytol (5 mg Fe/kg), to be administered 24 hours before the subject undergoes ferumoxytol-enhanced magnetic resonance imaging (MRI). These subjects will subsequently undergo surgery, and tissue analysis of surgically resected samples (specifically the number of iron-containing and non-iron-containing macrophages) will be correlated with imaging features on ferumoxytol-enhanced MRI.
干预措施: Tissue Analysis (Other)
结局指标
主要结局
Iron concentration measurements
时间窗: Day 1
Obtain susceptibility measurements and relaxation times (R2, R2\*, R2') in patients receiving ferumoxytol.
次要结局
- Macrophages on histopathology(Days 2-4)
研究者
Michael Iv
Clinical Assistant Professor
Stanford University