Fluorescent Dyes for Lymph Node Mapping
Fluorescent Dyes for Lymph Node Mapping
The goal of this clinical research study is to find lymph nodes before surgery using a dye
 called indocyanine green (IC-Green).

 Objectives:

 1. To determine the feasibility of using nonradioactive optical imaging techniques with
 indocyanine green (ICG) as a fluorescent contrast agent to identify all axillary lymph
 nodes.

 2. To determine the feasibility of using nonradioactive optical imaging techniques with ICG
 as a fluorescent contrast agent to characterize lymphatic architecture and function in
 women with breast cancer who are scheduled for axillary node dissection.
IC-Green Injections:

 If you are found to be eligible to take part in this study, a member of the study staff will
 give you between 6-16 injections of IC-Green through a needle in your hand, arm, and breast.
 The study doctor will discuss the number of injections that you will receive in more detail.
 The injections will be given after you are under anesthesia.

 These IC-Green injections will allow researchers to see the flow of the liquid through your
 body during imaging and locate the lymph nodes that will be removed during your standard of
 care surgery. After all of the IC-Green injections have been given, the imaging procedure
 will begin. Researchers will use an experimental camera that shines a special red light onto
 your skin causing the IC-Green to glow when the images are taken. The red light is like the
 red light in a grocery store scanner. The imaging procedure will take about 1 hour to
 complete.

 Before the IC-Green injections and during imaging, a member of the research staff will
 monitor and record your vital signs (blood pressure, breathing rate, heart rate, and
 temperature).

 After the IC-Green injections, a study staff member will closely monitor the injection site
 for possible side effects every 15 minutes during the first hour, and then every 30 minutes
 during the second hour. A study staff member will call you the next day and ask you to take
 your temperature. This phone call should last about 5 minutes.

 Follow-Up Evaluation:

 If you spend the night in the hospital after your surgery, a study staff member will visit
 you for a follow-up the day after surgery. At this visit, your temperature will be recorded
 and you will be asked how you are feeling and if you have had any side effects. The visit
 should last about 10 minutes.

 If you do not spend the night in the hospital after surgery, you will be contacted by phone
 the day after surgery. You will be asked the same questions described above, as well as what
 your temperature is. The phone call should last about 10 minutes.

 Length of Study:

 After all of the images have been taken, and the follow-up evaluation is complete, your
 participation in this study will be over.

 This is an investigational study. IC-Green is FDA approved and commercially available for
 mapping heart, liver, and eye function. The use of IC-Green for mapping the lymph nodes in
 breast cancer patients is investigational.

 The experimental camera, and the images taken with it, are being used for research purposes
 only and will not be used to manage your treatment.

 Up to 20 patients will be take part in this study. All will be enrolled at MD Anderson.
Inclusion Criteria:

 1. Subjects must be 18 years of age or older

 2. Diagnosis of breast cancer requiring axillary nodal dissection

 3. Negative urine pregnancy test within 72 hours prior to study drug administration, if
 female of childbearing potential

 4. Females of childbearing potential who agree to use a medically accepted method of
 contraception for a period of one month following the study. Medically acceptable
 contraceptives include (i) hormonal contraceptives (such as birth control pills,
 Depo-Provera, or Lupron Depot) if such use is approved by the subject's Oncologist;
 (ii) barrier methods (such as a condom or diaphragm) used with a spermicide, or (iii)
 an intrauterine device (IUD).

 5. Continuation of Inclusion #4: Non-childbearing potential is defined as physiologically
 incapable of becoming pregnant, including any female who is post-menopausal;
 postmenopausal is defined as the time after which a woman has experienced 12
 consecutive months of amenorrhea (lack of menstruation).

 6. Patients with a positive fine needle aspirate or core biopsy of their axillary nodes

 Exclusion Criteria:

 1. Women who are pregnant or breast-feeding

 2. Persons who are allergic to iodine

 3. A female of child-bearing potential who does not agree to use an approved
 contraceptive for one month after study participation

 4. History of ipsilateral axillary surgery including sentinel node biopsy

 5. Any patient who does not meet inclusion criteria for study