Additive Value of Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration (EBUS-TBNA) for Staging Non-Small Cell Lung Cancer in Patients Evaluated for Stereotactic Body Radiation Therapy

EBUS-TBNA:

If participant agrees to take part in this study, as a part of participant's
standard-of-care, participant will have an EBUS-TBNA before SBRT. Participant will have this
performed as an out-patient procedure while under general anesthetic. Participant will
receive a separate consent for this that will explain the procedure and the risks.

The samples collected from the EBUS-TBNA will be tested and compared with the results of
participant's standard PET/CT scans.

Follow-Up:

As a part of participant's standard-of-care, after SBRT participant will have a physical exam
and chest CT scan to check the status of the disease every 3 months for the first 2 years,
and then twice a year for the following year. After 3 years, participant will have these
visits 1 time a year.

Participant's medical information from these follow-up visits will be collected for this
study. All the information for the study will be stored in a password-protected system.

Length of Study Participation:

Participant's active participation in this study will be over after participant's tissue
samples are collected by EBUS-TBNA. Participant's medical information will continue to be
collected as long as participant is coming for follow-up visits.

This is an investigational study. The EBUS-TBNA is performed using FDA-approved and
commercially available methods. It is investigational to compare the results of EBUS-TBNA and
PET/CT scans to learn about the accuracy of these ways to find evidence of early stage lung
cancer.

Up to 150 participants will be enrolled in this study. All will take part at MD Anderson.

Inclusion Criteria:

1. Patient must be > 18 years old Age 18 years or older

2. Patient must have proven or suspected non small cell lung cancer (NSCLC) and be
clinical Stage I or IIa, according to the 7th edition staging system of the American
Joint Commission on Cancer for lung cancer (T1or T2a, N0 or N1, M0)

3. Patient must have a PET/CT obtained within 40 days of having the EBUS-TBNA

4. Patient is being considered for SBRT

5. Patient or the patient's legally authorized representative must provide written
informed consent prior to registration and any study-related procedures

6. If the patient is a survivor of a prior invasive cancer, all of the following criteria
must apply: a) Patient has undergone potentially curative therapy for all prior
malignancies b) No evidence of active / recurrent disease within 5 years

Exclusion Criteria:

1. Patient has received prior chemotherapy or radiotherapy for this cancer

2. Patients already scheduled to receive conventional radiotherapy, chemotherapy,
biological therapy, vaccine therapy, or surgery as treatment (except at disease
progression)

3. Patients malignancy is consistent with well differentiated neuroendocrine (carcinoid)
histology

4. Patients who are planning to undergo treatment in a different institutionMalignancy
consistent with a neuroendocrine histology