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 sites322 target enrollmentNovember 5, 2007

Overview

No summary available.

Registry

who.int

Start Date

November 5, 2007

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional

Sex

All

Sponsor

McMaster University (Canada)

•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