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The Utility of Positron Emission Tomography (PET) in Staging of Patients With Potentially Operable Non-Small Cell Lung Carcinoma


N/A
18 Years
N/A
Not Enrolling
Both
Lung Cancer

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Trial Information

The Utility of Positron Emission Tomography (PET) in Staging of Patients With Potentially Operable Non-Small Cell Lung Carcinoma


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Diagnostic

Principal Investigator

Carolyn E. Reed, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Medical University of South Carolina

Authority:

United States: Federal Government

Study ID:

CDR0000067368

NCT ID:

NCT00004138

Start Date:

September 1999

Completion Date:

Related Keywords:

  • Lung Cancer
  • 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
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
University of Chicago Cancer Research CenterChicago, Illinois  60637
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Medical University of South CarolinaCharleston, South Carolina  29425-0721
Mount Sinai School of MedicineNew York, New York  10029
UCSF Cancer Center and Cancer Research InstituteSan Francisco, California  94115-0128
Barnes-Jewish HospitalSaint Louis, Missouri  63110
Massachusetts General Hospital Cancer CenterBoston, Massachusetts  02114
Massey Cancer CenterRichmond, Virginia  23298-0037
Holden Comprehensive Cancer CenterIowa City, Iowa  52242-1009
Allegheny General HospitalPittsburgh, Pennsylvania  15212-4772
William Beaumont HospitalRoyal Oak, Michigan  48073
Marlene and Stewart Greenebaum Cancer Center, University of MarylandBaltimore, Maryland  21201-1595
Lutheran General HospitalPark Ridge, Illinois  60068
Latter Day Saints HospitalSalt Lake City, Utah  84143
Western Pennsylvania Cancer InstitutePittsburgh, Pennsylvania  15224
Morton Plant Mease Health CareClearwater, Florida  33756
Jameson Memorial HospitalNew Castle, Pennsylvania  16105
Lakeland Regional Medical CenterLakeland, Florida  33804
Veterans Affairs Medical Center - Iowa CityIowa City, Iowa  52246-2208
Westmoreland HospitalGreensburg, Pennsylvania  15601-2282