Positron Emission Tomography for Detecting 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.

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.