Positron Emission Tomography for Detecting Non-Small Cell Lung Cancer

This study has been completed.
Sponsor:
Collaborator:
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

December 10, 1999
April 6, 2009
September 1999
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Complete list of historical versions of study NCT00004138 on ClinicalTrials.gov Archive Site
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Positron Emission Tomography for Detecting Non-Small Cell Lung Cancer
The Utility of Positron Emission Tomography (PET) in Staging of Patients With Potentially Operable Non-Small Cell Lung Carcinoma

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.

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.

Interventional
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Primary Purpose: Diagnostic
Lung Cancer
  • Procedure: positron emission tomography
  • Procedure: radionuclide imaging
  • Radiation: fludeoxyglucose F 18
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00004138
CDR0000067368, ACOSOG-Z0050
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American College of Surgeons
National Cancer Institute (NCI)
Study Chair: Carolyn E. Reed, MD Medical University of South Carolina
National Cancer Institute (NCI)
January 2002

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP