The utility of positron emission tomography (PET)in staging patients with potentially operable non-small cell carcinoma
Originating Group
ACSOG Z0050
Surgical P.I.: Dr. Carolyn E. Reed
Participating Groups
TBA
Objectives
This is a study of 2-FDG positron emission tomography (FDG-PET) staging in patients with suspected or histologically confirmed stage I, stage II, or stage IIIa (N2) non-small cell lung cancer (NSCLC) by clinical assessment and for whom precise staging is to be done in order to make a surgical decision regarding pulmonary resection.
- Primary: To ascertain whether FDG-PET scanning can detect lesions that would preclude pulmonary resection in patients found to be surgical candidates by standard imaging precedures.
- Secondary: 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.
Eligibility Criteria
- Patient has either strongly suspected, or histologically or cytologically confirmed, newly diagnosed, untreated, single lesion bronchogenic NSCLC (adenocarcinoma, non-lobar/non-diffuse bronchioloalveolar carcinoma,large cell carcinoma, or squamous cell carcinoma). 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.
- Patient may be eligible without histologic or cytologic proof if 1) 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); 2) tumor is clinically resectable; and 3) an exploratory thoracotomy is planned.
- Patient must be medically fit for sugical staging procedures follwing the thoracic surgeon's evaluation of general medical fitness and pulmonary function, or be a candidate for resection of the clinical stage I, II, or IIIa lesion.
- Patient must have completed the standard staging procedures: diagnostic imaging with chest x-ray, CT of chest, CT of upper abdomen to include adrenals, a bone scan, and a brian image (either CT with contrast or MRI), without evidence of Stage IIIb or IV disease.
- Patient must have baseline alkaline phosphatase and calcium serum levels.
- Patient must not have had a prior PET scan for evaluation of their NSCLC.
- Patients must be able to tolerate PET, (i.e. not claustrophobic and able to lie supine for 1.5 hrs).
- Patient must be 18 yrs of age or older.
- Patient must not be pregnant. This is in order to avoid unnecessary fetal radiation exposure and because the optional use of furosemide is contraindicated in pregnancy. Pregnancy tests must be done if there is a possibility of pregnancy.
- Patient who has controlled diabetes mellitus is eligible, as evidenced by a fasting blood glucose value <150mg/dL without administration of any diabetic medications to control glucose level.
- A cancer survivor is eligible provided that the following criteria are met:(a) the patient has undergone potentially curative therapy for all prior malignancies,(b)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 (c) the patient is deemed by their treating physician to be at low risk for recurrene from prior malignancies.
Schema
Comments
Opened to accrual 10/99
Sample size 120 patients for the first stage of the study.
