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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 (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00004138
First received: December 10, 1999
Last updated: July 12, 2016
Last verified: July 2016

December 10, 1999
July 12, 2016
September 1999
December 2002   (final data collection date for primary outcome measure)
Proportion of patients with negative findings from FDG-PET scan [ Time Frame: Up to 1 month post-FDG-PET scan ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00004138 on ClinicalTrials.gov Archive Site
Proportion of false-positive lesions found by FDG-PET [ Time Frame: Up to 6 months post-surgery ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
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:

Primary Objective: To ascertain whether FDG-PET scanning can detect lesions that would preclude pulmonary resection in patients found to be surgical candidates by standard imaging procedures.

Secondary Objectives: To use the data collected to generate hypotheses to be used in future studies, such as which types of previously undetected lesions FDG-PET is best able to identify.

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Lung Cancer
  • Procedure: positron emission tomography
  • Procedure: radionuclide imaging
  • Radiation: fludeoxyglucose F 18
Experimental: FDG-PET scan + surgery

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.

Interventions:
  • Procedure: positron emission tomography
  • Procedure: radionuclide imaging
  • Radiation: fludeoxyglucose F 18

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
303
December 2002
December 2002   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Patient must be ≥ 18 years of age.
  2. a) Patient must have histologically or cytologically confirmed, newly diagnosed, untreated, single lesion bronchogenic NSCLC (adenocarcinoma, non-lobar/non- diffuse bronchioloalveolor cell carcinoma, large cell carcinoma, or squamous cell carcinoma). OR b) Patient is eligible based upon mediastinal node histology diagnosed by transbronchial biopsy, and if a separate ipsilateral lung lesion is clearly evident on radiographs, biopsy of the lung tumor is not required for this patient. OR c) Patient may be eligible without histologic or cytologic proof if;

    • The patient is strongly suspected to have primary bronchogenic carcinoma (e.g., heavy smoker with a new peripheral mass with typical appearance of lung cancer on chest radiograph although bronchoscopy and/or fine needle aspiration is nondiagnostic), and
    • The tumor is clinically resectable, and
    • An exploratory thoracotomy is planned.
  3. Patient must be medically fit for surgical staging procedures following the thoracic surgeon's evaluation of general medical fitness.
  4. Patient must be a candidate for resection of the clinical stage I, II, or IIIa lesion.
  5. Patient must be able to tolerate PET, (i.e., not claustrophobic and able to lie supine for 1.5 hrs).
  6. A signed and dated written informed consent must be obtained from the patient or the patient's legally acceptable representative prior to study participation.
  7. Female patient of childbearing potential must have a negative serum or urine pregnancy test, 72 hours prior to FDG-PET.

    • NOTE: This is in order to avoid unnecessary fetal radiation exposure and because the use of furosemide is contraindicated in pregnancy.
  8. Patient must complete the following standard staging procedures 60 days prior to registration.

    • CT scan of the chest and upper abdomen (include adrenals) with contrast
    • NOTE: Non-contrast CT scan may be used for patients with a peripheral suspicious nodule and no evidence of hilar or mediastinal adenopathy or invasion of central structures. All other lesions require IV contrast.
    • Bone scan
    • CT scan of the brain with and without contrast or MRI of brain
  9. A cancer survivor is eligible provided that ALL the following criteria are met and documented:

    • the patient has undergone potentially curative therapy for all prior malignancies, and
    • there has been no evidence of any prior malignancies for at least five years (except for completely resected cervical or non-melanoma skin cancer), and
    • the patient is deemed by their treating physician to be at low risk for recurrence from prior malignancies.

Exclusion Criteria:

  1. Patient has had a prior PET scan for evaluation of their NSCLC.
  2. Patient has evidence of stage IIIB or IV disease confirmed by diagnostic imaging such as chest X-ray, CT chest, CT abdomen, CT brain or MRI brain, and bone scan.
  3. Patient has uncontrolled diabetes mellitus, as evidenced by a fasting blood glucose value >200 mg/dL, within 12 hours of PET scan.
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00004138
ACOSOG-Z0050, CDR0000067368
No
Not Provided
Not Provided
Alliance for Clinical Trials in Oncology
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Study Chair: Carolyn E. Reed, MD Medical University of South Carolina
Alliance for Clinical Trials in Oncology
July 2016

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