The Utility of Positron Emission Tomography (PET) in Staging of Patients With Potentially Operable Non-Small Cell Lung Carcinoma
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Lung Cancer
- Sponsor
- Alliance for Clinical Trials in Oncology
- Enrollment
- 303
- Locations
- 23
- Primary Endpoint
- Proportion of patients with negative findings from FDG-PET scan
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient must be ≥ 18 years of age.
- •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.
- •Patient must be medically fit for surgical staging procedures following the thoracic surgeon's evaluation of general medical fitness.
- •Patient must be a candidate for resection of the clinical stage I, II, or IIIa lesion.
- •Patient must be able to tolerate PET, (i.e., not claustrophobic and able to lie supine for 1.5 hrs).
- •A signed and dated written informed consent must be obtained from the patient or the patient's legally acceptable representative prior to study participation.
- •Female patient of childbearing potential must have a negative serum or urine pregnancy test, 72 hours prior to FDG-PET.
Exclusion Criteria
- •Patient has had a prior PET scan for evaluation of their NSCLC.
- •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.
- •Patient has uncontrolled diabetes mellitus, as evidenced by a fasting blood glucose value \>200 mg/dL, within 12 hours of PET scan.
Outcomes
Primary Outcomes
Proportion of patients with negative findings from FDG-PET scan
Time Frame: Up to 1 month post-FDG-PET scan
Secondary Outcomes
- Proportion of false-positive lesions found by FDG-PET(Up to 6 months post-surgery)