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

Group 2:

If the patient agrees to take part in this study, the following information about their
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 the patient may experience
The results of the diagnosis from the biopsy sample Researchers will take appropriate steps
to keep the patient's information private. However, there is no guarantee of absolute
privacy. The patient's 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 the patient's 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:

The patient's 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 the patient agrees to take part in this study, the following information about the
patient's 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 the patient may experience
The results of the diagnosis from the biopsy sample Researchers will take appropriate steps
to keep the patient's information private. However, there is no guarantee of absolute
privacy. The patient's 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 the patient's routine lung biopsy, the doctor will use the MIMIG intervention system
to help guide the needle for the biopsy the lung biopsy. The patient will also have an
intravenous (IV) needle placed in the patient's vein to give the patient indocyanine green
(IC-Green). IC-Green is a dye that allows researchers to see the patient's veins and other
organs during the biopsy.

Length of Study:

After the lung biopsy is complete, the patient's 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:

- 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:

- Age less than 18 years.

- Pregnant or nursing females.

- Known allergy to iodine or intravenous contrast agent.

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

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

- 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

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