A Multimodality Image-guided System for Peripheral Lung Cancer Diagnosis and Therapy

Group 2:

If you agree to take part in this study, the following information about your routine
standard of care lung biopsy will be collected:

- The accuracy of the procedure

- How long it takes to complete the procedure

- How long the needle is inserted to collect the biopsy sample

- The number of CT scans used during the procedure

- The radiation dose level used

- Any complications and/or side effects you may experience

- The results of the diagnosis from the biopsy sample

Researchers will take appropriate steps to keep your information private. However, there is
no guarantee of absolute privacy. Your information will be kept in a password-protected
computer at MD Anderson for up to 7 years and will only be permitted to be viewed by the
study doctor and members of the research staff.

During your routine lung biopsy, the doctor will use the MIMIG intervention system to help
guide the needle for the biopsy the lung biopsy.

Length of Study:

Your active participation on this study will be over after the lung biopsy procedure is
over.

Description of Procedure:

The first CT scan will be used as a map to guide a needle into the tumor with the MIMIG
intervention system. After that, a second CT scan will be done to confirm that the needle
tip has been properly inserted inside the lung tumor. Based on the results from these
images, the tumor will then be biopsied the same way it would be as part of normal routine
care.

This is an investigational study. The use of the MIMIG intervention system to help guide
the needle for the lung biopsy is not FDA approved or commercially available. The use of the
MIMIG intervention system is investigational.

Up to 24 patients will take part in this study. All will be enrolled at MD Anderson.

Group 3:

If you agree to take part in this study, the following information about your routine
standard of care lung biopsy will be collected:

- The accuracy of the procedure

- How long it takes to complete the procedure

- How long the needle is inserted to collect the biopsy sample

- The number of CT scans used during the procedure

- The radiation dose level used

- Any complications and/or side effects you may experience

- The results of the diagnosis from the biopsy sample

Researchers will take appropriate steps to keep your information private. However, there is
no guarantee of absolute privacy. Your information will be kept in a password-protected
computer at MD Anderson and will only be permitted to be viewed by the study doctor and
members of the research staff.

During your routine lung biopsy, the doctor will use the MIMIG intervention system to help
guide the needle for the biopsy the lung biopsy. You will also have an intravenous (IV)
needle placed in your vein to give you indocyanine green (IC-Green). IC-Green is a dye that
allows researchers to see your veins and other organs during the biopsy.

Length of Study:

After the lung biopsy is complete, your active participation on this study will be over.

Description of Procedure:

The first CT scan will be used as a map to guide a needle into the tumor with the MIMIG
intervention system. After that, a second CT scan will be done to confirm that the needle
tip has been properly inserted inside the lung tumor. A fiberoptic endoscope (a small
camera with a light) will be inserted through the CT guided needle to the tumor to help
doctors see the tumor blood vessels. IC-Green will also be given by IV to allow doctors to
see the blood vessels of the tumor. Based on the results from these images, the tumor will
then be biopsied the same way it would be as part of normal routine care.

This is an investigational study. The use of the MIMIG intervention system to help guide
the needle for the lung biopsy is not FDA approved or commercially available. The use of the
MIMIG intervention system is investigational. The use of fiberoptic endoscope for lung
tumor vessels imaging is not FDA approved or commercially available. The use of fiberoptic
endoscope is investigational. The use of IC-Green in combination with fiberoptic endoscope
for lung tumor vessels imaging is not FDA approved or commercially available. The use of
IC-Green in combination with fiberoptic endoscope is investigational.

Up to 24 patients will take part in this study. All will be enrolled at MD Anderson.

Inclusion Criteria:

1. Adult (age ≥ 18 years) subjects with peripheral lung lesions that are <1.5 cm in size
who are planning to undergo percutaneous image guided lung biopsy as part of their
routine medical care.

2. Ability to understand and willingness to sign Informed Consent Document (ICD)

Exclusion Criteria:

1. Age less than 18 years.

2. Pregnant or nursing females.

3. Known allergy to iodine or intravenous contrast agent.

4. Known allergy or anaphylactic reaction to indocyanine green (ICG).

5. Patients with renal dysfunction (GFR <60) or patients on dialysis

6. Patients with liver dysfunction: total bilirubin > 2.5 mg/dl; albumin < 2.5 mg/dl;
alanine aminotransferase (ALT), aspartate aminotransferase (AST) > 5 times upper
limits of normal

7. Uncorrectable coagulopathy prohibiting biopsy. (INR > 1.5 and/ or platelets < 50,000)