Positron Emission Tomography for Detecting Non-Small Cell Lung Cancer - Full Text View

Sponsor:	American College of Surgeons
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00004138

Purpose

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
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer Nuclear Scans

Drug Information available for: Fluorodeoxyglucose F18

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

September 1999

Detailed Description:

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004138

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Locations

United States, California
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, United States, 94143-0128
United States, Florida
Lakeland Regional Medical Center
Lakeland, Florida, United States, 33805-4500
Morton Plant Mease Health Care
Clearwater, Florida, United States, 33756
United States, Illinois
Lutheran General Hospital
Park Ridge, Illinois, United States, 60068
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
United States, Indiana
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202-5289
United States, Iowa
Holden Comprehensive Cancer Center
Iowa City, Iowa, United States, 52242-1009
Veterans Affairs Medical Center - Iowa City
Iowa City, Iowa, United States, 52246-2208
United States, Maryland
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, United States, 21201-1590
United States, Massachusetts
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
United States, Missouri
Barnes-Jewish Hospital
Saint Louis, Missouri, United States, 63110
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Mount Sinai School of Medicine
New York, New York, United States, 10029-6574
United States, North Carolina
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
United States, Pennsylvania
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212-4772
Westmoreland Hospital
Greensburg, Pennsylvania, United States, 15601-2282
Western Pennsylvania Cancer Institute
Pittsburgh, Pennsylvania, United States, 15224
Jameson Memorial Hospital
New Castle, Pennsylvania, United States, 16105
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425-0721
United States, Utah
Latter Day Saints Hospital
Salt Lake City, Utah, United States, 84143
United States, Virginia
Massey Cancer Center
Richmond, Virginia, United States, 23298-0037

Sponsors and Collaborators

American College of Surgeons

National Cancer Institute (NCI)

Investigators

Study Chair:

Carolyn E. Reed, MD

Medical University of South Carolina

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Kozower BD, Meyers BF, Reed CE, Jones DR, Decker PA, Putnam JB Jr. Does positron emission tomography prevent nontherapeutic pulmonary resections for clinical stage IA lung cancer? Ann Thorac Surg. 2008 Apr;85(4):1166-9; discussion 1169-70.

Reed CE, Harpole DH, Posther KE, Woolson SL, Downey RJ, Meyers BF, Heelan RT, MacApinlac HA, Jung SH, Silvestri GA, Siegel BA, Rusch VW; American College of Surgeons Oncology Group Z0050 trial. Results of the American College of Surgeons Oncology Group Z0050 trial: the utility of positron emission tomography in staging potentially operable non-small cell lung cancer. J Thorac Cardiovasc Surg. 2003 Dec;126(6):1943-51.

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

Keywords provided by National Cancer Institute (NCI):

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

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on November 27, 2009