Viewing Study NCT00136890



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Study NCT ID: NCT00136890
Status: COMPLETED
Last Update Posted: 2013-01-15
First Post: 2005-08-25

Brief Title: PET Imaging in Potentially Surgically Resectable Non-small Cell Lung Cancers
Sponsor: Ontario Clinical Oncology Group OCOG
Organization: Ontario Clinical Oncology Group OCOG

Study Overview

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
Status: COMPLETED
Status Verified Date: 2013-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: ELPET
Brief 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 liveradrenals 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 contrastgadolinium
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None