Near-Infrared Imaging of Fluorescent Dyes for Lymph Node Mapping
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
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
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.
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.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Percentage of Nodes Identified by ICG Among All Resected Lymph Nodes for Each Patient
Injection and Imaging procedure takes 1+ hour to complete
Funda Meric-Bernstam, MD
UT MD Anderson Cancer Center
United States: Food and Drug Administration
|UT MD Anderson Cancer Center||Houston, Texas 77030|
|UT Health Science Center - Houston||Houston, Texas 77030|