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

PRIMARY OBJECTIVES:

I. To compare the imaging characteristics of 18F-FSPG PET/CT with standard-of-care, 18F-FDG
PET/CT.

II. To compare the imaging characteristics of 18F-FSPG PET/CT to standard-of-care 18F-FDG
PET/CT in patients with newly diagnosed lung cancer.

III. To determine whether 18F-FSPG uptake in lung cancer can be predicted based on
correlation with CD44 and amino acid transport system xc- (xC-) expression in surgical
pathology specimens.

OUTLINE:

Patients undergo 18F-FDG PET/CT scan per standard of care. Within 15 working days, patients
also undergo 18F-FSPG PET scan over 60 minutes followed by an 18F-FSPG PET/CT scan over 30
minutes.

After completion of study, patients are followed up for 2 years if needed for diagnosis.

Inclusion Criteria:

- Have an indeterminate untreated 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

- Have a newly diagnosed, untreated primary lung cancer diameter 7 mm or more.

- Be able to give informed 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

- Must agree at the time of study entry to undergo clinically indicated biopsy(ies) or a
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-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

- A recognized active lung infection

- 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.