Follow-up of Patients With Curative-intent Surgical Resection for NSCLC : CT Scanning Versus 18 FDG Imaging.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Disease-free survival from the date of operation to the date of recurrence or censured at the date of last follow-up visit or date of the death.
研究概览
简要总结
The guidelines and institutional practices recommended more frequent visits the two years following curative-intent therapy for non-small cell lung cancer (NSCLC).No international consensus is published concerning follow-up of resected NSCLC patients.Recent studies have outlined that positron emission tomography (PET) scanning may be accurate in early detection of recurrences by comparison to computed tomography (CT). The aim of this study is to compare follow-up by conventional methods versus PET. Patients are randomly assigned to two arms. In the first arm, thorax CT with liver and adrenal gland sections, abdominal ultrasonography and nuclear bone scintigraphy are performed every 6 months after surgery for two years. In the second arm, PET scanning is only. For brain metastasis detection, CT is performed in the two arms. Recurrences are detected during scheduled or unscheduled procedure in asymptomatic patients. PET and CT are interpreted separately by two nuclear physicians and two radiologists. The direct cost of follow-up procedure is determined in the two groups. The calculated sample is composed of 60 patients in each arm to detect significant difference. The Ethics Committee of Universitary Hospital of Limoges approves the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients who underwent resection for NSCLC
- •Informed consent
排除标准
- •Patients with a mixed histology profile that included small cell carcinoma or neuroendocrine tumor cells.
- •Patients with non-resected NSCLC or with metastasis
- •Patients who have previous malignancy, except basal cell carcinoma of the skin -
结局指标
主要结局
Disease-free survival from the date of operation to the date of recurrence or censured at the date of last follow-up visit or date of the death.
次要结局
- - Overall survival from the date of the operation to the death
- - Specificity, sensibility and accuracy of TEP to detect recurrence
- - Direct cost of follow-up from the Frenc Healthcare insurance