Lung cancer remains the leading cause of cancer deaths in men and women. Although overall survival remains poor, early stage non-small cell lung cancer (NSCLC) is potentially curable. Improved staging has led to stage-specific therapies such that patients with early stage NSCLC are potential candidates for surgical resection, and those with more advanced disease are spared the morbidity and risk of mortality from thoracotomy and pulmonary resection. Despite contemporary staging techniques, 25-50% of patients who appear to have limited disease amenable to surgical resection go on to die from metastatic lung cancer. If occult micro-metastatic disease that becomes evident later could be detected reliably during the pre-operative assessment, patients harboring such disease could be spared a non-curative thoracotomy. PET imaging has the potential to detect mediastinal and extrathoracic metastatic disease not detected by conventional imaging modalities. This prospective, multicenter trial will enroll patients with biopsy-proven clinical stage I-IIIA NSCLC who are considered to be candidates for surgical resection with curative intent. Preoperatively, patients will be randomized to conventional staging for metastatic disease (CT liver/adrenals, total body bone scan, and CT with contrast or MRI with gadolinium of the brain) versus whole body PET or PET-CT and brain CT or MRI with contrast/gadolinium.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
337
Patients randomized to PET staging will undergo FDG-PET or PET-CT as well as some form of cranial imaging (CT or MRI)
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada
London Health Sciences Centre
London, Ontario, Canada
Credit Valley
Mississauga, Ontario, Canada
The Ottawa Hospital - General Campus
Ottawa, Ontario, Canada
Scarborough Hospital
Scarborough Village, Ontario, Canada
Sunnybrook/TEGH
Toronto, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
St. Joseph's Health Care
Toronto, Ontario, Canada
Patients correctly upstaged by PET versus conventional staging
Time frame: November 2007
Patients erroneously understaged by PET versus conventional staging
Time frame: November 2008
Overall survival
Time frame: August 2012
Prognostic ability of PET standard uptake value
Time frame: August 2011
Sensitivity and specificity of PET in the mediastinum
Time frame: November 2008
Cost-effectiveness of using PET versus conventional staging
Time frame: August 2012
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