Trial Information

Diagnostic Nodal Staging for Melanoma With Nuclear and Near-Infrared (NIR) Molecular Optical Imaging

Indocyanine Green Injections:

IC-Green Injections:

If you are found to be eligible to take part in this study, you will receive a total of
10-16 injections of IC-Green through a needle in your arms or legs, starting in your hands
or feet (5-8 on each arm/leg), depending on the location of the tumor. You may receive
additional injections in the torso, if there is a tumor in the torso area and the study
doctor thinks it is needed. The study doctor will discuss the number of injections that you
will receive in more detail. The injections will be given to you before surgery and all
injections will be given intradermally (into or between layers of the skin).

The IC-Green injections will allow researchers to see how fluid flows through your body
during imaging. This information may help future researchers more easily locate lymph nodes
in patients scheduled for lymph node surgery.

After all of the IC-Green injections have been given, the imaging procedure will begin. To
perform the imaging procedures, 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 and will be performed before and during the surgery.

Before the IC-Green injections and again during the imaging procedure, a member of the
research staff will monitor and record your vital signs (blood pressure, breathing rate,
heart rate, and temperature). Vital sign measurements will be taken every 15 minutes for 1
hour after the IC-Green injections, and every 30 minutes during the second hour. A study
staff member will also closely monitor the injection site at these times for possible side
effects. A study staff member will call you the next day and ask you to take your
temperature. This 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.

Follow-Up Evaluation:

If you spend the night in the hospital after surgery, a study staff member will visit you in
person the day after surgery. At this visit, your temperature will be recorded, you will be
asked how you are feeling, and if you have experienced 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 the surgery and you will be asked what your current temperature is, how you
are feeling, and if you have experienced any side effects. The phone call should last about
10 minutes.

This is an investigational study. IC-Green is FDA approved and commercially available for
assessment of cardiac output, hepatic function, liver blood flow, ophthalmic angiography,
and mapping heart, liver, and eye function. The use of IC-Green for mapping the lymph nodes
in melanoma patients is investigational.

IC-Green is FDA approved to be injected into the vein. Giving IC-Green injections into or
between layers of the skin and the device that is used to give the injections are
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 18 patients will take part in Part 1 of this study. All will be enrolled at MD
Anderson.

Complete Lymph Node Dissection:

If you agree to participate in this part of the study, you will have additional imaging
performed before the surgery and again in your follow-up visit.

The imaging will be performed at MD Anderson just before the surgery and during your
regularly scheduled standard of care follow-up visit about 4-6 months after surgery to learn
what the lymphatic channels look like after completely healing from surgery.

Before each imaging session, you will receive a total of 10-16 injections of IC-Green
through a needle in your arms and hands or legs and feet, (5-8 on each arm/leg), depending
on the location of the tumor. Researchers will use the experimental camera to perform the
imaging procedure. You may receive additional injections in the torso, if there is a tumor
in the torso area and the study doctor thinks it is needed.

The imaging procedures will take up to 2 hours to complete each time.

For all participants, before the IC-Green injections and again during the imaging procedure,
a member of the research staff will monitor and record your vital signs (blood pressure,
breathing rate, heart rate, and temperature). Vital sign measurements will be taken every
15 minutes for 1 hour after the IC-Green injections, and every 30 minutes during the second
hour. A study staff member will also closely monitor the injection site at these times for
possible side effects.

Length of Study:

Your participation will be over after all the images have been taken and the long-term
follow-up is complete.

This is an investigational study. IC-Green is FDA approved and commercially available for
assessment of cardiac output, hepatic function, liver blood flow, ophthalmic angiography,
and mapping heart, liver, and eye function. The use of IC-Green for mapping the lymph nodes
in melanoma patients is investigational.

IC-Green is FDA approved to be injected into the vein. Giving IC-Green injections into or
between layers of the skin and the device that is used to give the injections are
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 6 patients will participate in this part of the study. All will be enrolled at MD
Anderson.