Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Indocyanine Green (IC-Green) Injections + Imaging

5 intradermal injections, 25 µg IC-Green in 0.1 mL of saline, in locations on the extremity (i.e. arm or leg) correlating with the tumor draining nodal basin to begin. Corresponding injections performed on the contralateral limbs.

Indocyanine Green (IC-Green)

Nonradioactive optical imaging with indocyanine green as a fluorescent contrast agent prior to sentinel lymph node biopsy or lymph node surgery.

Imaging

Janice N. Cormier, MD, MPH, BS

Objectives:

1. To determine the feasibility of using microdose amounts of near-infrared (NIR) fluorescent contrast agent to image tumor-draining and contralateral lymphatics in melanoma patients prior to standard-of-care sentinel lymph node biopsy OR completion lymph node dissection (axillary or inguinofemoral)
2. To determine the feasibility of using nonradioactive optical imaging techniques with indocyanine green (ICG) as a fluorescent contrast agent to characterize lymphatic architecture and function by correlating the observed lymphatic structure and function with tumor and nodal status as determined from standard-of-care immunohistochemical evaluation.

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.

Nuclear and Near-Infrared (NIR) Imaging in Melanoma

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

Procedure feasible if 18 out of 24 evaluable patients have 80% or more nodes identified by ICG among all resected nodes. Descriptive analyses performed to report the mean percentage and its 95% confidence interval of the nodes identified by ICG among the total resected nodes of all evaluable subjects. Outcome will be tabulated by age, different tumor stage, nodal status, and body mass index.

National Cancer Institute (NCI)

University of Texas

M.D. Anderson Cancer Center

Breast Neoplasms

Central Nervous System Depressants

All Drugs and Chemicals

Anesthetics

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.

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.

Indocyanine green (ICG)

Funda Meric-Bernstam, MD

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.

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 title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Nuclear and Near-Infrared (NIR) Imaging in Melanoma	NCT01295931	Melanoma	Indocyanine Gre... Imaging	18 Years -	M.D. Anderson Cancer Center
Fluorescent Dyes for Lymph Node Mapping	NCT01095913	Breast Cancer	Indocyanine gre...	18 Years -	M.D. Anderson Cancer Center

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