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临床试验/NCT00188422
NCT00188422已完成1 期

Surveillance Low Dose Computed Tomography of the Thorax in Patients With High Grade Extremity Soft Tissue Sarcoma

University Health Network, Toronto1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2003年8月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
70
试验地点
1
主要终点
Detection of metastases

研究概览

简要总结

The primary outcome of this study is the detection of lung metastases comparing Low dose CT (LDCT) and Minimum dose CT (MnDCT) with CXR.

Hypothesis

  1. LDCT and MnDCT have similar sensitivity for the detection of lung nodules (metastases).
  2. MnDCT of the thorax detects a larger number of nodules (metastases) than CXR.

详细描述

A 3-year prospective phase II non-randomized study commenced May 2003 enrolling 60 high-risk patients with Intermediate and High Grade STS. Each patient is kept under radiological surveillance for 3 years unless lung metastases are detected. Conventional thoracic imaging for staging and surveillance of STS patients is shown in Figure 1. In the trial, LDCT and MnDCT are added to each imaging visit (Figure 1). A 2-view CXR (CR) is performed (Direct View, Kodak, Rochester) followed by thoracic CT scans performed on a Siemens 16 row MDCT (Sensation 16, Siemens, Erlangen), CT acquisition; 120kVp, 5/2.5/2.5mm. Images are reconstructed with high and low spatial frequency filters and soft copy viewing is performed on a standalone PACS workstation using standard mediastinal (w 350, l 40) and lung (w 1500, l -600) settings. Examinations are performed with varying mAs; SDCT 120 mAs, LDCT 40 mAs and MnDCT 20 mAs. The examinations are evaluated, blinded to the results of the alternative and previous studies, for the presence of nodules (defined as a non-calcified focal opacity ≥3 mm < 3 cm). Surveillance imaging is commenced 3 months post surgery.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • High Grade Soft tissue sarcoma

排除标准

  • 未提供

结局指标

主要结局

Detection of metastases

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (1)

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