NCT00136890

PET Imaging in Potentially Surgically Resectable Non-small Cell Lung Cancers

The Impact of Positron Emission Tomography (PET) Imaging in Staging Potentially Surgically Resectable Non-small Cell Lung Cancers: A Prospective Multicentre Randomized Clinical Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 337 (actual)
• Sponsor: Ontario Clinical Oncology Group (OCOG) · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Non-small-cell Lung Carcinoma

Interventions

Type	Name	Description
PROCEDURE	PET Imaging	Patients randomized to PET staging will undergo FDG-PET or PET-CT as well as some form of cranial imaging (CT or MRI)

Timeline

• Start date: 2004-07-01
• Primary completion: 2008-11-01
• Completion: 2013-01-01
• First posted: 2005-08-29
• Last updated: 2013-01-15

Locations

8 sites across 1 country: Canada