The impact of Positron Emission Tomography (PET) imaging in staging potentially surgically resectable non-small cell lung cancers: a prospective, multicentre randomised clinical trial

McMaster University (Canada)0 个研究点目标入组 322 人开始时间: 2007年11月5日最近更新: 2015年1月13日

适应症

试验速览

暂无简介。

•1. Histological or cytological proof of NSCLC
•2. Stage I, II, or IIIA NSCLC based upon clinical staging
•3. The primary lesion appears technically appropriate for surgical resection, based on information from the Chest X-Ray (CXR) and CT thorax
•4. Male or female NSCLC patients, 18 years and older

•1. Poor pulmonary function precluding radical surgery (inadequate pulmonary reserve for radical surgery) with predicted post-resection Forced Exipiratory Volume in One second (FEV1) less than 0.8 l or less than 40% predicted, and Diffusing capacity of the Lung for Carbon Monoxide (DLCO) less than 40 % predicted
•2. Poor performance status (Eastern Cooperative Oncology Group [ECOG] grade 3 - 4)
•3. Significant concurrent medical problems (e.g. uncontrolled diabetes, active cardiac problems, significant chronic obstructive pulmonary disease) making the patient unfit for surgery
•4. Pregnant or lactating females
•5. Unable to lie supine for imaging with PET
•6. Patients with previously treated cancer other than nonmelanotic skin cancer or carcinoma in situ of the cervix, unless disease-free for 5 years or greater
•7. Patients who, at the time of the initial evaluation, have already undergone a whole body PET/PET-CT, CT brain, MRI brain, total body bone scan or mediastinoscopy within 8 weeks prior to randomisation will be excluded. However, patients who have had a CT scan of the thorax with abdomen are not excluded
•8. Failure to provide informed consent

发起方

McMaster University (Canada)