Randomized Study of PET/CT in Pre-Operative Staging of Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 189
- 试验地点
- 1
- 主要终点
- Number of futile thoracotomies
研究概览
简要总结
Patients with possible operable non-small cell lung cancer are randomised to conventional staging, or conventional staging and PET/CT. According to, patients with operable tumor will be referred to surgery, and the number of thoracotomies and futile thoracotomies wil be compared with the two groups in order to asses the possible benefit of PET/CT.
详细描述
Patients with possible operable NSCLC after staging with CT are randomised to PET-CT with FDG or not, prior to mediastinoscopy. All patients are referred to mediastinoscopy unless a positive FDG uptake results in a positive biopsy suggesting stage IV disease.
Biopsies are performed according to the following criteria:
- Lymph nodes are numbered according the Mountain classification, and abnormal lesions must be confirmed histologically, by mediastinoscopy or thoracotomy.
- PET-positive lesions in the liver must be biopsied unless ultrasound or MRI unequivocally indicate the lesions are benign cysts or haemangioma.
- PET-negative adrenal lesions are accepted without biopsy if CT scan indicate the lesion is a benign adenoma.
- PET-positive bone lesions must be evaluated by plain x-ray, CT, MRI, or bone scintigraphy. In case of equivocal findings a biopsy must be performed.
- PET-positive brain lesions must be confirmed by CT or MRI.
Number of patients:
Patients with clinically operable NSCLC after CT-staging are included. All patients must have mediastinoscopy performed.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically operable NSCLC after CT
- •Fit for thoracotomy and lobectomy or pneumectomy after lung function tests
- •CT-scan of thorax, including liver and adrenals with no signs of distant metastases.
- •No medical condition contraindication surgery.
- •No claustrophobia.
- •Negative pregnancy test.
- •No diabetes mellitus.
- •Signed informed consent.
排除标准
- •Radiologically M1 disease.
- •Known claustrophobia.
- •Estimated FEV1 < 30% of expected after surgery.
- •Diabetes mellitus.
结局指标
主要结局
Number of futile thoracotomies
时间窗: Within 1 year
次要结局
- Number of thoracotomies and survival(Within 1 year)