Computed Tomography (CT) Perfusion Imaging of Lung Cancer

Drug/Device Information

1) Contrast

30 cc bolus of a low osmolar, iodinated CT contrast agent, which is FDA approved and used in
the clinical CT Imaging procedure.

2) Scanner

The 64 row-multidetector row CT unit (LightSpeed VCT, GE Healthcare, Milwaukee, WI) is FDA
approved for clinical CT imaging

Research Design and Methods

1) Primary Endpoint

1. Diagnostic yield of tumor perfusion measurements using a contrast assisted computed
tomography technique.

2) Secondary Endpoints

1. Reproducibility of tumor blood flow estimates derived by CT.

2. Assessment of the association between tumor vascularity responses after two cycles of
chemotherapy and subsequent best tumor response according to standard anatomic response
evaluation criteria (RECIST).

3. Predictive value of tumor blood flow for patient survival, compared to the predictive
power of tumor size determinations.

Inclusion Criteria:

- Patient with any stage non-small cell lung cancer (NSCLC) who will undergo imaging
with CT of the chest with intravenous contrast as standard of care. Other imaging
tests will be performed as clinically indicated.

- Patient should be receiving, or planning to receive, or have received systemic
therapy (chemotherapy and/or novel agents) treatment with or without radiotherapy.
Patients should not be receiving adjuvant or postoperative treatment but neoadjuvant
treatment is allowed.

- Histologically or cytologically proven NSCLC.

- At least one measurable primary or other intrathoracic/supraclavicular lesion ≥ 1 cm,
according to Response Evaluation Criteria in Solid Tumors (RECIST); this lesion
should be either proven to be malignant by biopsy or be considered malignant based on
its evolution on previous imaging studies. A scan within 3-6 months prior to
registration can be used as the baseline scan.

- Age 18 years or older and ability to provide informed consent.

- Subjects must use medically appropriate contraception if sexually active; women of
childbearing potential must not be pregnant or breastfeeding

- Subjects must have normal renal function to participate. Standard laboratory testing
to evaluate renal function will be performed prior to administering IV contrast and
will be available as standard of care. Renal impairment is defined as a glomerular
filtration rate of less than 60 ml/min/1.73 m2 BSA, derived from the patients' serum
creatinine concentration.

Exclusion Criteria:

- Subjects of reproductive potential, who are sexually active but unwilling and/or
unable to use medically appropriate contraception, or women who are pregnant or
breastfeeding;

- Established allergy to iodine containing contrast media