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Positron Emission Tomography for Detecting Non-small Cell Lung Cancer



Positron Emission Tomography for Detecting Non-small Cell Lung Cancer

For Condition: squamous cell lung cancer,stage 3A non-small cell lung cancer,adenocarcinoma of the lung,stage 1 non-small cell lung cancer,stage 2 non-small cell lung cancer,large cell lung cancer,bronchoalveolar cell lung cancer
Status: No longer recruiting
Sponsor(s): American College of Surgeons , National Cancer Institute (NCI)
Synopsis: 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.
Details: OBJECTIVES: - Determine the efficacy of fludeoxyglucose F 18 positron emission tomography (FDG-PET) in detecting lesions that would preclude pulmonary resection in patients with non-small cell lung cancer. 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.
Eligibility:
Study Type:
  Interventional, Diagnostic
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically proven clinical stage I, II, or IIIA single lesion bronchogenic non-small cell lung cancer (NSCLC) - Adenocarcinoma - Nonlobar/nondiffuse bronchoalveolar cell carcinoma - Large cell carcinoma - Squamous cell carcinoma - Mediastinal node histology diagnosed by transbronchial biopsy - Biopsy not required if separate ipsilateral lung lesion clearly evident on radiograph - 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: - Tumor clinically resectable - Exploratory thoracotomy planned - Newly diagnosed, untreated disease amenable to curative surgery - No prior positron emission tomography (PET) scan for NSCLC PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Not specified Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - Not specified Renal: - Not specified Other: - Able to tolerate PET - Not claustrophobic - Able to lie supine for 1.5 hours - Medically fit for surgical staging procedures or clinical resection - Not pregnant or nursing - Negative pregnancy test - No uncontrolled diabetes mellitus as evidenced by fasting blood glucose greater than 200 mg/dL - No prior malignancy within the past 5 years except completely resected cervical cancer or nonmelanoma skin cancer or cancer that has been treated with potentially curative therapy and is deemed to be at low risk for recurrence PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - Not specified Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - See Disease Characteristics
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
CarolynReed,  Study Chair,  Medical University of South Carolina

University of Chicago Cancer Research Center
Chicago,  Illinois,  60637-1470
United States
 

Mount Sinai School of Medicine
New York City,  New York,  10029-6574
United States
 

Morton Plant Mease Health Care
Clearwater,  Florida,  33756
United States
 

UCSF Cancer Center and Cancer Research Institute
San Francisco,  California,  94143-0128
United States
 

Western Pennsylvania Cancer Institute
Pittsburgh,  Pennsylvania,  15224
United States
 

Lutheran General Hospital
Park Ridge,  Illinois,  60068
United States
 

Holden Comprehensive Cancer Center
Iowa City,  Iowa,  52242-1009
United States
 

Massey Cancer Center
Richmond,  Virginia,  23298-0037
United States
 

Indiana University Cancer Center
Indianapolis,  Indiana,  46202-5289
United States
 

Duke Comprehensive Cancer Center
Durham,  North Carolina,  27710
United States
 

Lakeland Regional Medical Center
Lakeland,  Florida,  33805-4500
United States
 

Latter Day Saints Hospital
Salt Lake City,  Utah,  84143
United States
 

Marlene and Stewart Greenebaum Cancer Center, University of Maryland
Baltimore,  Maryland,  21201-1590
United States
 

Massachusetts General Hospital Cancer Center
Boston,  Massachusetts,  02114
United States
 

Jonsson Comprehensive Cancer Center, UCLA
Los Angeles,  California,  90095-1781
United States
 

Medical University of South Carolina
Charleston,  South Carolina,  29425-0721
United States
 

Jameson Memorial Hospital
New Castle,  Pennsylvania,  16105
United States
 

Allegheny General Hospital
Pittsburgh,  Pennsylvania,  15212-4772
United States
 

Veterans Affairs Medical Center - Iowa City
Iowa City,  Iowa,  52246-2208
United States
 

Memorial Sloan-Kettering Cancer Center
New York City,  New York,  10021
United States
 

William Beaumont Hospital
Royal Oak,  Michigan,  48073
United States
 

Barnes-Jewish Hospital
St. Louis,  Missouri,  63110
United States
 

Westmoreland Hospital
Greensburg,  Pennsylvania,  15601-2282
United States
 


Additional Information:
Study ID Numbers:
  CDR0000067368;  ACOSOG-Z0050
Study Start Date: 
Record last reviewed: February 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004138

Other Squamous Cell Lung Cancer Studies:
1. Chemotherapy and Radiation Therapy With or Without Epoetin alfa in Treating Patients With Stage IIIA or Stage IIIB Non-Small Cell Lung Cancer

2. Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With Stage IIIA Non-small Cell Lung Cancer

3. Genetic Changes in Patients With Non-Small Cell Lung Cancer Who Are Receiving Vinorelbine and Gemcitabine Before Surgery

4. Combination Chemotherapy Plus Radiation Therapy With or Without AE-941 in Treating Patients With Stage III Non-small Cell Lung Cancer That Cannot Be Removed By Surgery

5. Paclitaxel, Carboplatin, and Radiation Therapy With or Without Adjuvant Paclitaxel and Carboplatin in Treating Patients With Stage II or Stage III Unresectable Non-Small Cell Lung Cancer

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