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Positron Emission Tomography for Detecting Non-Small Cell Lung Cancer

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00004138
First received: December 10, 1999
Last updated: April 6, 2009
Last verified: January 2002
History of Changes
  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: Primary Purpose: 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:

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

  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:

ClinicalTrials.gov Identifier: NCT00004138     History of Changes
Other Study ID Numbers: CDR0000067368, ACOSOG-Z0050
Study First Received: December 10, 1999
Last Updated: April 6, 2009
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:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
 Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on June 18, 2013