A Phase 3 Study of 99mTC-EC-DG SPECT/CT Versus PET/CT in Lung Cancer

Inclusion criteria

• . The subject is a male or female patient at least 18 years old.
• . The subject must agree at the time of enrollment to have the following procedures:
• . The patient has had a non incisional biopsy demonstrating definitive evidence for lung cancer OR have clinical evidence and CT scan results consistent with a diagnosis of lung cancer. Cytology results confirming lung cancer from a bronchoscope procedure will also be acceptable. A copy of the actual report (biopsy/cytology or CT scan) must be requested by the patient through a medical release form if not already done. The copy must be available to the study doctor within 15 days of the PET imaging study.
• . The patient will not be receiving treatment for lung cancer (surgery, radiation, and/or chemotherapy), or, if the patient has had lung cancer in the past, all previous therapy was completed at least 3 months prior to being enrolled in the study.
• . If a tissue diagnosis of the primary lesion was not done prior to enrollment, the patient must agree to have a tissue diagnosis of the primary lesion within 15 days of the PET/CT study but prior to initiation of therapy, independent of the PET/CT results.
• . The patient must be referred for a PET/CT scan on the basis of clinical and radiological (CT) evidence for a diagnosis of lung cancer.
• . The patient will have an Eastern Co-operative Oncology Group (ECOG) performance rating \< or = 2.
• . The patients will be males or non-pregnant, non-lactating females who are postmenopausal, naturally or surgically sterile, or who agree to use effective contraceptive methods throughout the course of the study. Postmenopausal is defined as at least 12 months natural spontaneous amenorrhea, or at least 6 weeks following surgical menopause (bilateral oophorectomy).