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Near-Infrared Imaging of Fluorescent Dyes for Lymph Node Mapping


Phase 1
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

Near-Infrared Imaging of Fluorescent Dyes for Lymph Node Mapping


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Percentage of Nodes Identified by ICG Among All Resected Lymph Nodes for Each Patient

Outcome Time Frame:

Injection and Imaging procedure takes 1+ hour to complete

Safety Issue:

No

Principal Investigator

Funda Meric-Bernstam, MD

Investigator Role:

Study Chair

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

2009-0564

NCT ID:

NCT01095913

Start Date:

March 2010

Completion Date:

Related Keywords:

  • Breast Cancer
  • Near-Infrared Imaging
  • Fluorescent Dyes
  • Lymph Node Mapping
  • Indocyanine green
  • IC-Green
  • nonradioactive optical imaging
  • fluorescent contrast agent
  • ICG
  • lymph nodes
  • axillary nodal dissection
  • Breast Neoplasms

Name

Location
UT MD Anderson Cancer Center Houston, Texas  77030
UT Health Science Center - Houston Houston, Texas  77030