Fluorescent Dyes for Lymph Node Mapping

Breast Cancer Clinical Trial

Official title:

Near-Infrared Imaging of Fluorescent Dyes for Lymph Node Mapping

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01095913
• Other study ID #: 2009-0564
• Status: Completed
• Phase: Phase 1
• First received: March 26, 2010
• Last updated: January 7, 2015
• Start date: March 2010
• Est. completion date: January 2014

Study information

• Verified date: January 2015
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical research study is to find lymph nodes before surgery using a dye called indocyanine green (IC-Green).

Objectives:

1. To determine the feasibility of using nonradioactive optical imaging techniques with indocyanine green (ICG) as a fluorescent contrast agent to identify all axillary lymph nodes.

2. To determine the feasibility of using nonradioactive optical imaging techniques with ICG as a fluorescent contrast agent to characterize lymphatic architecture and function in women with breast cancer who are scheduled for axillary node dissection.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Drug:
• Indocyanine green (ICG)
Injections performed after induction of anesthesia for surgery; 25 µg ICG/injection, with injections of 0.1 cc each to be made starting in the hand, arm, and areolar regions of the breast.

Locations

Country	Name	City	State
United States	University of Texas Health Science Center - Houston	Houston	Texas
United States	University of Texas MD Anderson Cancer Center	Houston	Texas

Sponsors (4)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	American Cancer Society, Inc., National Cancer Institute (NCI), The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Nodes Identified by ICG Among All Resected Lymph Nodes for Each Patient		Injection and Imaging procedure takes 1+ hour to complete	No

External Links

•   University of Texas MD Anderson Cancer Center website