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临床试验/NCT00188279
NCT00188279已完成2 期

Minimum Dose Computed Tomography of the Thorax for Follow-up in Patients With Resected Lung Carcinoma

University Health Network, Toronto1 个研究点 分布在 1 个国家目标入组 311 人开始时间: 2005年6月21日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
311
试验地点
1
主要终点
Detection of local recurrent disease

研究概览

简要总结

This study is designed to help decide whether a CAT scan performed at a very low dose of radiation (Minimum dose CT scan) is better than a Chest X-Ray in detecting recurrence of lung cancer in the chest (after surgery).

详细描述

Lung Carcinoma is expected to kill 18,900 men and women in Canada in 2004. This is more than the combined total for the next three common cancers. The most important factor that determines patient survival is the stage of disease at presentation. Surgical resection is the best chance of cure. However, patients who undergo lung resection with curative intent have a significant incidence of a second lung cancer at 2% per year and a recurrence rate of 38% at 5 years. The current follow-up of these patients relies on periodic physical examination and chest radiography(CXR). However, CXR is insensitive in the detection of lung nodules when compared to standard Computed Tomography of the thorax (SDCT). Computed Tomography detects smaller lung nodules than CXR however, the radiation dose from a SDCT is roughly equivalent to 20 CXR examinations. Screening studies using Low Dose CT of the Thorax (LDCT) in subjects at high risk for lung cancer have demonstrated that LDCT detects three times as many nodules as CXR and four times as many primary lung cancers at one-third the dose of SDCT. Phantom and clinical work with LDCT performed at UHN/MSH suggests that a further reduction in radiation dose (Minimum Dose CT -MnDCT) is possible for nodule detection. Minimum dose CT is performed at a dose one sixth of a SDCT.In addition, if MnDCT is confirmed to be a more sensitive nodule detection technique, it could be used to

  1. Increase the interval between repeat out-patient assessment and thereby 2. Reduce the overall cost of surveillance and inconvenience to the patient and 3. Free up clinic time for the surgeon to review more patients and reduce waiting lists

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •lung cancer patients undergoing resection with intent to cure

排除标准

  • •age < 18 years

研究组 & 干预措施

MnDCT

Experimental

干预措施: Minimum Dose Computed Tomography (MnDCT) scan (Procedure)

结局指标

主要结局

Detection of local recurrent disease

时间窗: 5 years

Evaluate the incidence and significance of sub-5mm lung nodules in this patient population

时间窗: 5 years

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 (1)

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