Non-small-cell Lung Carcinoma Clinical Trial
Official title:
The Impact of Positron Emission Tomography (PET) Imaging in Staging Potentially Surgically Resectable Non-small Cell Lung Cancers: A Prospective Multicentre Randomized Clinical Trial
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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