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Sponsors and Collaborators: |
American College of Surgeons National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00004138 |
RATIONALE: Imaging procedures, such as positron emission tomography (PET), may improve the ability to detect the extent of non-small cell lung cancer.
PURPOSE: Diagnostic trial to study the effectiveness of PET for detecting lesions in patients who have newly diagnosed stage I, stage II, or stage IIIA non-small cell lung cancer.
Condition | Intervention |
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Lung Cancer |
Procedure: positron emission tomography Procedure: radionuclide imaging Radiation: fludeoxyglucose F 18 |
Study Type: | Interventional |
Study Design: | Diagnostic |
Official Title: | The Utility of Positron Emission Tomography (PET) in Staging of Patients With Potentially Operable Non-Small Cell Lung Carcinoma |
Study Start Date: | September 1999 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive fludeoxyglucose F 18 (FDG) IV followed 45-60 minutes later by positron emission tomography (PET) imaging. Confirmatory studies, such as biopsy, fine needle aspiration, or other imaging studies are then conducted to confirm the PET findings.
Patients with no mediastinal nodal or distant metastases identified by FDG-PET scan may undergo thoracotomy and pulmonary resection within 1 month of evaluation.
Patients are followed at 5-6 months after surgery.
PROJECTED ACCRUAL: A total of 120-235 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically proven clinical stage I, II, or IIIA single lesion bronchogenic non-small cell lung cancer (NSCLC)
Suspected primary bronchogenic carcinoma allowed without histologic or cytologic proof (e.g., heavy smoker with new peripheral mass with typical appearance of lung cancer on x-ray) if:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
Able to tolerate PET
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Study Chair: | Carolyn E. Reed, MD | Medical University of South Carolina |
Study ID Numbers: | CDR0000067368, ACOSOG-Z0050 |
Study First Received: | December 10, 1999 |
Last Updated: | April 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00004138 History of Changes |
Health Authority: | United States: Federal Government |
stage I non-small cell lung cancer stage II non-small cell lung cancer squamous cell lung cancer large cell lung cancer |
stage IIIA non-small cell lung cancer adenocarcinoma of the lung bronchoalveolar cell lung cancer |
Thoracic Neoplasms Respiratory Tract Diseases Adenocarcinoma, Bronchiolo-Alveolar Lung Neoplasms Lung Diseases Non-small Cell Lung Cancer |
Adenocarcinoma of Lung Adenocarcinoma Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Neoplasms by Histologic Type Respiratory Tract Diseases |
Lung Neoplasms Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |