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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Melanoma

Thank you

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.


Inclusion Criteria:



1. Subjects must be 18 years of age or older

2. Diagnosis of invasive melanoma with (ARM A) biopsy documenting a T2 (greater than 1
mm thickness) primary tumor undergoing standard of care sentinel lymph node biopsy
(SLN) for definitive pathologic staging, OR (ARM B) documented node-positive (stage
III) disease undergoing standard-of-care axillary or inguinofemoral lymph node
dissection for regional disease control.

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

4. Female of childbearing potential who agrees to use a medically accepted method of
contraception for a period of one (1) month following the study. Medically acceptable
contraceptives include (i) hormonal contraceptives such as birth control pills,
Depo-Provera, or Lupron Depot) if such 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). 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).

5. For patients undergoing a complete axillary or inguinofemoral lymph node dissection a
positive previous sentinel lymph node or a positive fine needle aspirate or core
biopsy of their axillary or inguinofemoral lymph 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 or femoral surgery not including previous sentinel
lymph node biopsy procedure.

5. Persons who do not meet inclusion criteria.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Percentage of Nodes Identified by Indocyanine Green (ICG) Among All Resected Lymph Nodes

Outcome Time Frame:

18-24 hours after procedure

Safety Issue:

No

Principal Investigator

Janice N. Cormier, MD, MPH, BS

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

2010-0577

NCT ID:

NCT01295931

Start Date:

February 2011

Completion Date:

Related Keywords:

  • Melanoma
  • Near-infrared
  • NIR
  • Indocyanine green
  • ICG
  • Melanoma
  • Fluorescent dyes
  • Lymph nodes
  • Experimental camera
  • Melanoma

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030