18F-FSPG PET/CT in Imaging Patients with Newly Diagnosed Lung Cancer or Indeterminate Pulmonary Nodules

Inclusion Criteria

• An indeterminate pulmonary nodule (IPN) (7–30 mm diameter) on CT, or an indeterminate lung mass (> 30 mm diameter), without prior examinations that establish that the lesion has been stable for two or more years
• Untreated; OR
• An adult patient with a newly diagnosed, untreated primary lung cancer diameter 7 mm or more; AND
• The patient must provide informed written consent, which will include a layman’s explanation of the estimated amount of additional radiation that the patient will receive from the investigational PET/CT scan using 18F-FSPG
• The patient must agree at the time of study entry to undergo clinically indicated biopsy(ies) or 24-month period of follow-up, as needed, to resolve the etiology of their IPN(s) or lung mass(es)

Exclusion Criteria

• Pregnant or lactating patients will be excluded, as will females of childbearing potential who refuse to undergo a serum or urinary beta-human chorionic gonadotropin (HCG) pregnancy test the day of either the 18F-FSPG or the 18F-FDG PET/CT scans in accordance with the standard policy of the Medical Imaging Service at our facility; women who have experienced 24 consecutive months of amenorrhea, have reached at least 60 years of age, or have had a tubal ligation or hysterectomy documented in their medical records are considered not to be of childbearing potential for the purposes of this protocol
• Patients with a body weight of 400 pounds or more or a body habitus or disability that will not permit the imaging protocol to be performed, due to the compromise in image quality on both CT and PET/CT; if the standard-of-care 18F-FDG/PET was of diagnostic in quality as determined by the official clinical interpretation, then this will be presumptive evidence that the patient’s body habitus and/or disabilities should not prevent a diagnostic quality 18F-FSPG PET/CT scan, either
• A recognized active lung infection (this will confound the standard-of-care 18F-FDG PET/CT scan)
• Previous systemic or radiation treatment for cancer of any type within 1 year
• For patients who do not have a tissue diagnosis: * Non-oncologic severe co-morbidities suggesting a life span of less than two years if not treated, as determined by the potential subject’s treating physician * If severe co-morbidities are present, the treating physician should indicate that a life span of 2 years is expected if treatments are effective * This exclusion is to prevent loss of the needed 2 year CT follow-up to establish a benign diagnosis for lesions lacking tissue diagnosis if extremely fragile subjects are enrolled and then experience an untimely, unrelated death