Fluorescent Dyes for Lymph Node Mapping

January 7, 2015 updated by: M.D. Anderson Cancer Center

Near-Infrared Imaging of Fluorescent Dyes for Lymph Node Mapping

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson Cancer Center
      • Houston, Texas, United States, 77030
        • University of Texas Health Science Center - Houston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: IC-Green Injections
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.
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.
Other Names:
  • IC-Green

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Percentage of Nodes Identified by ICG Among All Resected Lymph Nodes for Each Patient
Time Frame: Injection and Imaging procedure takes 1+ hour to complete
Injection and Imaging procedure takes 1+ hour to complete

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
M.D. Anderson Cancer Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)
The University of Texas Health Science Center, Houston
American Cancer Society, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Funda Meric-Bernstam, MD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 26, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 30, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 8, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 7, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2009-0564

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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