Dynamic Perfusion Computed Tomography in Patients With Localized Non-small Cell Lung Cancer

PRIMARY OBJECTIVES:

I. To describe perfusion computed tomography (CT) parameters and their changes in non-small
cell lung cancer (NSCLC) tumors prior to, during, 1 month after, and 3 months after
stereotactic body radiation therapy (SBRT).

SECONDARY OBJECTIVES:

I. To correlate tumor perfusion parameters with clinical tumor response on follow up per
standard of care.

TERTIARY OBJECTIVES:

I. To correlate changes in serum levels of deoxyribonucleic acid (DNA) methylation and
circulating tumor cell (CTC) with clinical response rates and perfusion parameters.

OUTLINE:

Patients undergo dynamic perfusion computed tomography (DPCT) at baseline, during SBRT (after
2 of 3 fractions or 3 of 5 fractions), and then at 1 and 3 months post stereotactic body
radiation therapy.

After completion of study, patients are followed up at 6, 12, 18, and 24 months.

Inclusion Criteria:

- Biopsy proven non-small cell lung cancer

- Minimum tumor dimension >= 1 cm (preferably >= 2 cm)

- No clinical evidence of nodal disease (N1-N3) as assessed by CT and/or positron
emission tomography (PET)/CT

- Zubrod performance status 0-2

- Women of child-bearing potential and men must agree to use adequate contraception
(hormonal or barrier method of birth control; abstinence) prior to study entry, for
the duration of study participation, and for 90 days following completion of therapy;
should a woman become pregnant or suspect she is pregnant while participating in this
study, she should inform her treating physician immediately

- A female of child-bearing potential is any woman (regardless of sexual
orientation, having undergone a tubal ligation, or remaining celibate by choice)
who meets the following criteria:

- Has not undergone a hysterectomy or bilateral oophorectomy; or

- Has not been naturally postmenopausal for at least 12 consecutive months
(i.e., has had menses at any time in the preceding 12 consecutive months)

- No prior radiation to the same area

- No concurrent chemotherapy

- Evaluated by radiation oncologist to be appropriate SBRT candidate and scheduled to
undergo SBRT as part of their care

- Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

- Patients with tumors < 1 cm

- Patients with nodal disease or distant metastatic disease

- Patients may not be receiving any other investigational agents

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements

- Patients must not be pregnant

- Patients with allergies to iodinated contrast not amenable to pre-medication

- Patients who are not able to lie supine with arms raised, and cooperate with
breathholding instructions