Fluorescent Dyes for Lymph Node Mapping

Launched by M.D. ANDERSON CANCER CENTER · Mar 26, 2010

Keywords

ClinConnect Summary

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...

Gender

FEMALE

Eligibility criteria

• 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