Randomized Study of Positron Emission Tomography - Computed Tomography (PET/CT) in Pre-Operative Staging of Lung Cancer

Study Overview
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Brief Summary
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Patients with possible operable non-small cell lung cancer are randomised to conventional staging, or conventional staging and PET/CT. According to, patients with operable tumor will be referred to surgery, and the number of thoracotomies and futile thoracotomies wil be compared with the two groups in order to asses the possible benefit of PET/CT.

Detailed Description
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Patients with possible operable NSCLC after staging with CT are randomised to PET-CT with FDG or not, prior to mediastinoscopy. All patients are referred to mediastinoscopy unless a positive FDG uptake results in a positive biopsy suggesting stage IV disease. Biopsies are performed according to the following criteria: Lymph nodes are numbered according the Mountain classification, and abnormal lesions must be confirmed histologically, by mediastinoscopy or thoracotomy. PET-positive lesions in the liver must be biopsied unless ultrasound or MRI unequivocally indicate the lesions are benign cysts or haemangioma. PET-negative adrenal lesions are accepted without biopsy if CT scan indicate the lesion is a benign adenoma. PET-positive bone lesions must be evaluated by plain x-ray, CT, MRI, or bone scintigraphy. In case of equivocal findings a biopsy must be performed. PET-positive brain lesions must be confirmed by CT or MRI. Number of patients: Patients with clinically operable NSCLC after CT-staging are included. All patients must have mediastinoscopy performed. All patients referred to mediastinoscopy can be randomised after informed consent. A total of 430 consecutive, non-selected patients are planned. It is anticipated that approximately 60% of the referred patients with clinical stage I-IIIa NSCLC will undergo thoracotomy, and a risk of type I and II error of 5% and 10%, respectively, is accepted. Thus a total of 215 patients are randomised in each arm in order to observe an absolute difference of 15% in the number of thoracotomies. This number seems to be sufficient to evaluate differences in the secondary endpoints. After inclusion of a total of 220 patients, corresponding to 110 PET-scans, an interim analyses are performed. In case of a highly significant difference in the number of thoracotomies (p < 0,001) the study will be closed.

Official Title
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Randomized Study of PET/CT in Pre-Operative Staging of Lung Cancer

Conditions
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Non-Small Cell Lung Cancer, Thoracotomy

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinically operable NSCLC after CT Fit for thoracotomy and lobectomy or pneumectomy after lung function tests CT-scan of thorax, including liver and adrenals with no signs of distant metastases. No medical condition contraindication surgery. Age 18-80 No claustrophobia. Negative pregnancy test. No diabetes mellitus. Signed informed consent. Exclusion Criteria: Radiologically M1 disease. Pregnancy Known claustrophobia. Estimated FEV1 < 30% of expected after surgery. Diabetes mellitus.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Conventional staging<br>Staging with CT, mediastinoscopy and bronchoscopy | |
| Conventional staging and PET/CT<br>Staging with CT, mediastinoscopy and bronchoscopy, and PET/CT performed prior to mediastinoscopy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of futile thoracotomies |  | Within 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of thoracotomies and survival |  | Within 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NSCLC, PET/CT, Surgery, FDG, staging