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

Inclusion Criteria

• •1. The subject is a male or female patient at least 18 years old.
• •2. The subject must agree at the time of enrollment to have the following procedures:
• •* A tissue diagnosis of the primary lesion either prior to enrollment or within 15 days of the PET/CT study but before initiation of therapy
• •* A SPECT/CT procedure
• •* A baseline DCCT scan
• •* A whole-body bone scan
• •* A follow-up focused DCCT scan (if indicated)
• •3. 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.
• •4. 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.
• •5. 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.
• •6. 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.
• •7. The patient will have an Eastern Co-operative Oncology Group (ECOG) performance rating \< or = 2.
• •8. 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).
• •9. Females of childbearing potential and males with female sexual partners of childbearing potential must agree to use one of the following acceptable birth control methods:
• •1. Surgically sterile (hysterectomy or bilateral oophorectomy)
• •2. Surgically sterile (bilateral tubal ligation with surgery at least 6 weeks prior to study initiation - documentation is required)
• •3. Intrauterine device (IUD) in place for at least 3 months
• •4. Double-barrier method (condom and diaphragm) with spermicide for at least 14 days prior to screening and through study completion
• •5. Stable hormonal contraceptive (oral, topical, vaginal or implanted/injected) for at least 3 months prior to study and through study completion
• •6. Abstinence
• •7. Single-barrier method for at least 14 days prior to screening and through study completion for vasectomized males or females with vasectomized partners
• •10. The patient will have fasting blood glucose of \< 200 mg/dL at screening.
• •11. The patient will have reported clinical symptoms consistent with a diagnosis of lung cancer.
• •12. The patient must be able to tolerate SPECT/CT and PET/CT imaging. This includes:
• •1. lying in the same position without moving for approximately 45 minutes
• •2. able to tolerate a confined area (ie, not claustrophobic)
• •3. ability to hold their arms overhead for approximately 45 minutes
• •13. The patient must be able to fast and/or follow diet restrictions prior to SPECT/CT and PET/CT imaging.
• •14. Patients must fast for at least 6 hours prior to the injection for the study.
• •15. The patient must be able to eat a high protein/low carbohydrate meal as the last meal before SPECT/CT and PET/CT imaging. However, if the site has its own standard of care requirements for fasting and/or diet restrictions for PET as an alternative to this recommendation, the same fasting and/or diet restrictions used for PET imaging should be applied for the SPECT imaging.
• •16. The patient must be able to make the scheduled appointments within the designated time windows (PET/CT imaging within 7 days of qualifying for the study, the second imaging session with SPECT/CT imaging 1-15 days after the initial imaging visit, with at least 24 hours between PET/CT and SPECT/CT imaging).
• •17. The patient must have safety laboratory values that, in the opinion of the Investigator, do not place the patient at undue risk if the patient were to participate in the study. This includes (but is not limited to):
• •1. alanine aminotransferase \< or = 2.5 × ULN
• •2. aspartate aminotransferase \< or = 2.5 × ULN
• •3. creatinine \< or = 2.5 × ULN
• •4. bilirubin \< or = 2.0 × ULN
• •18. The patient must be able to understand and provide signed informed consent.
• •19. Females of childbearing potential must have a negative urine or serum β-hCG pregnancy test at screening.