18F-FSPG PET/CT in Diagnosing Early Lung Cancer in Patients With Lung Nodules

PRIMARY OBJECTIVES:

I. Comparison of fluorine F 18 L-glutamate derivative BAY94-9392 (18F-FSPG) accumulation with
fludeoxyglucose F-18 (18F-FDG) accumulation to assess whether
(4S)-4-(3-18F-Fluoropropyl)-L-Glutamate (18F-FSPG)-PET is better at discriminating between
benign and malignant nodules.

SECONDARY OBJECTIVES:

I. To develop and validate early lung cancer detection biomarkers that would directly impact
the growing need to integrate imaging and non-invasive molecular diagnostics for
indeterminate pulmonary nodules and allow physicians to avoid unnecessary invasive procedures
in patients with benign lung disease.

OUTLINE:

Patients receive 18F-FSPG intravenously (IV) and, undergo a PET/CT scan over 30-60 minutes.
Within 24 hours-14 days, patients receive 18F-FDG and undergo a second PET/CT scan over 30-60
minutes.

After completion of study, patients are followed up within 24-72 hours.

Inclusion Criteria:

- Pulmonary nodule between the size of 7 to 30 mm. Subjects with multiple nodules may be
eligible if the dominant nodule is 7 to 30 mm

- Undergoing standard of care 18F-FDG PET imaging (for indeterminate pulmonary nodule)

- Current or former cigarette smoker, with >= 20 pack years

- Documented informed consent

Exclusion Criteria:

- History or previous diagnosis of lung cancer

- Cancer diagnosis within the last 5 years

- Pregnant or nursing