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

Sponsors and Collaborators:	American College of Surgeons 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

MedlinePlus related topics: Cancer Lung Cancer Nuclear Scans

Drug Information available for: Fluorodeoxyglucose F18

U.S. FDA Resources

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

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

Show 23 Study Locations

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

Study placed in the following topic categories:

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

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 May 07, 2009