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临床试验/NCT01336803
NCT01336803已完成2 期

Pilot Differentiation of Bone Sarcomas and Osteomyelitis With Ferumoxytol-Enhanced MRI

Heike E Daldrup-Link1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2011年8月最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
32
试验地点
1
主要终点
T2* Relaxation Time of Bone Sarcomas and Osteomyelitis Subjects

研究概览

简要总结

This pilot trial studies the differentiation of bone sarcomas and osteomyelitis with ferumoxytol-enhanced magnetic resonance imaging (MRI). Imaging procedures that allow doctors to more accurately differentiate between malignant bone sarcomas and osteomyelitis may help in diagnosing patients correctly and may result in more timely treatment.

详细描述

BACKGROUND; In this study, T1, T2, and T2* represent parameters of magnetic resonance imaging (MRI).

The T1 relaxation time, also known as the spin-lattice relaxation time, is a measure of how quickly the net magnetization vector (NMV) recovers to its ground state in the direction of B0. T1 is assessed immediately post-contrast. A T1-weighted image (T1WI ) is one of the basic pulse sequences in MRI and demonstrates differences in the T1 relaxation times of tissues. A T1WI relies upon the longitudinal relaxation of a tissue's net magnetization vector (NMV).

T2 is a time constant for the decay of transverse magnetization arising from natural interactions at the atomic or molecular levels, and be considered the "natural" or "true" T2 of the tissue. However, in any nuclear magnetic resonance (NMR) experiment, transverse magnetization decays much faster than would be predicted by natural atomic and molecular mechanisms. Accordingly, T2 * is the time constant for the decay of transverse magnetization as observed in a tissue during a MRI scan, and be considered the"effective T2" (represented as T2*). T2* is always ≤ T2. In this study, T2 * is assessed after 24 hours.

OUTLINE:

Patients receive ferumoxytol intravenously (IV) and then undergo ferumoxytol-enhanced MRI up to 1 hour after infusion and up to 24 hours post-infusion.

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
10 Years 至 21 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Feraheme

Experimental

Intravenous injection of Feraheme, 5 mg Fe/kg

干预措施: Feraheme (Drug)

Feraheme

Experimental

Intravenous injection of Feraheme, 5 mg Fe/kg

干预措施: Magnetic Resonance Imaging (MRI) scan (Procedure)

结局指标

主要结局

T2* Relaxation Time of Bone Sarcomas and Osteomyelitis Subjects

时间窗: 24 hours

Differentiation of bone sarcomas and osteomyelitis with ferumoxytol-enhanced magnetic resonance imaging (MRI) was assessed as the difference of mean T2 \* relaxation time of bone sarcoma and osteomyelitis subjects. The outcome is reported as the difference of the mean T2 \* values, with standard deviation.

次要结局

  • Differentiation of CD163-positive Tumor-associated Macrophages (TAM) in Lymphomas and Bone Sarcomas(24 hours)
  • Differentiation of Bone Sarcomas Pre-ferumoxytol and Post-ferumoxytol Contrast(Baseline and Post-Treatment-24 hours)
  • Differentiation of Lymphoma and Bone Sarcomas With Ferumoxytol-enhanced MRI(24 hours)
  • Differentiation of CD68-positive Tumor-associated Macrophages (TAM) in Lymphomas and Bone Sarcomas(24 hours)

研究者

发起方
Heike E Daldrup-Link
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Heike E Daldrup-Link

Professor of Radiology (General Radiology)

Stanford University

研究点 (1)

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