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

Study Overview
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Brief Summary
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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.

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

Conditions
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Non-small-cell Lung Carcinoma

Intervention / Treatment
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* Procedure: PET Imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histological or cytological proof of NSCLC Stage I, II, or IIIA NSCLC based upon clinical staging The primary lesion appears technically appropriate for surgical resection, based on information from the chest x-ray (CXR) and CT thorax. Age over 18 years Exclusion Criteria: Poor pulmonary function precluding radical surgery (inadequate pulmonary reserve for radical surgery) with predicted post-resection forced expiratory volume in 1 second (FEV1) < 0.8 liter or < 40% predicted, and diffusing capacity of the lung for carbon monoxide (DLCO) < 40% predicted Poor performance status (Eastern Cooperative Oncology Group [ECOG] 3-4) Significant concurrent medical problems (e.g. uncontrolled diabetes, active cardiac problems, significant chronic obstructive pulmonary disease) making the patient unfit for surgery Pregnant or lactating females Unable to lie supine for imaging with PET Patients with previously treated cancer other than non-melanotic skin cancer or carcinoma in situ of the cervix, unless disease-free for 5 years or greater 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 randomization will be excluded. However, patients who have had a CT scan of the thorax with abdomen are not excluded. Failure to provide informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1<br>Conventional Staging | |
| Experimental: 2<br>PET Imaging | Procedure: PET Imaging<br>* Patients randomized to PET staging will undergo FDG-PET or PET-CT as well as some form of cranial imaging (CT or MRI)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients correctly upstaged by PET versus conventional staging |  | November 2007 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients erroneously understaged by PET versus conventional staging |  | November 2008 | 
| Overall survival |  | August 2012 | 
| Prognostic ability of PET standard uptake value |  | August 2011 | 
| Sensitivity and specificity of PET in the mediastinum |  | November 2008 | 
| Cost-effectiveness of using PET versus conventional staging |  | August 2012 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Positron-Emission Tomography, PET Scan, Lung Cancer, Thoracic Surgery, Diagnostic, Randomized Controlled Trial, Oncology