Lymphatic and Systemic Immunity Changes in Post-radiation Lymphedema Development

Study Overview
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Brief Summary
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The goal of this study is to find out which immune molecules, cells, and genes are involved in the development of lymphedema (LE), so that medicines that target them can be considered for treating lymphedema. The hypothesis is that LE is a systemic, autoimmune-like disease that is initiated by inflammatory cytokines induced by surgery, radiation, and possibly chemotherapy in genetically susceptible patients.

Official Title
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Lymphatic and Systemic Immunity Changes in Post-radiation Lymphedema Development

Conditions
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Lymphedema

Intervention / Treatment
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* Drug: Indocyanine Green (ICG)
* Device: Near-infrared Fluorescence Lymphatic Imaging (NIRFLI)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants must be at least 18 years of age Participants must have been clinically diagnosed with breast cancer and scheduled for axillary lymph node dissection (ALND) and radiation treatment at MD Anderson (receiving chemotherapy, mastectomy or breast-conserving surgery, ALND (>10 nodes) and radiation treatment for breast cancer, identified by Drs. Mittendorf and Shaitelman of the Nellie B. Connally Breast Cancer Center at MD Anderson) Ambulatory and possessing all four limbs No prior radiation therapy Negative urine pregnancy test within 36 hours prior to study drug administration, if of childbearing potential Females participants must complete the Female Enrollment Form. Childbearing potential participants must agree to use one of the medically accepted forms of contraception for a period of one month after study participation. Female participants who meet the criteria for non-childbearing will still complete the Female Enrollment Form, but are not restricted to the use of contraception following study participation. Exclusion Criteria: Participants with a known or suspected allergy to iodine Participants who are breastfeeding, pregnant or trying to become pregnant Severe underlying chronic illness or disease (other than breast cancer) Participants not capable of keeping moderately still for the imaging portion of the study session ( 1 hour for imaging)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Cancer-treated patients receiving NIRFLI<br>Near-infrared Fluorescence Lymphatic Imaging (NIRFLI) using Indocyanine Green (ICG) is used to visualize lymphatic vessel anatomy and function. | Drug: Indocyanine Green (ICG)<br>* Near-infrared Fluorescence Lymphatic Imaging (NIRFLI) using Indocyanine Green (ICG) is used to visualize lymphatic vessel anatomy and function.<br>Device: Near-infrared Fluorescence Lymphatic Imaging (NIRFLI)<br>* Near-infrared Fluorescence Lymphatic Imaging (NIRFLI) using Indocyanine Green (ICG) is used to visualize lymphatic vessel anatomy and function.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lymphatic propulsive velocity as assessed by NIRFLI |  | immediately before surgery | 
| Lymphatic propulsive velocity as assessed by NIRFLI |  | immediately before radiation (which is 6-8 weeks after surgery) | 
| Lymphatic propulsive velocity as assessed by NIRFLI |  | 6 months after radiation | 
| Lymphatic propulsive velocity as assessed by NIRFLI |  | 12 months after radiation | 
| Lymphatic propulsive velocity as assessed by NIRFLI |  | 24 months after radiation | 
| Lymphatic propulsive frequency as assessed by NIRFLI |  | immediately before surgery | 
| Lymphatic propulsive frequency as assessed by NIRFLI |  | immediately before radiation (which is 6-8 weeks after surgery) | 
| Lymphatic propulsive frequency as assessed by NIRFLI |  | 6 months after radiation | 
| Lymphatic propulsive frequency as assessed by NIRFLI |  | 12 months after radiation | 
| Lymphatic propulsive frequency as assessed by NIRFLI |  | 24 months after radiation | 
| Percent extravascular dye as assessed by NIRFLI |  | immediately before surgery | 
| Percent extravascular dye as assessed by NIRFLI |  | immediately before radiation (which is 6-8 weeks after surgery) | 
| Percent extravascular dye as assessed by NIRFLI |  | 6 months after radiation | 
| Percent extravascular dye as assessed by NIRFLI |  | 12 months after radiation | 
| Percent extravascular dye as assessed by NIRFLI |  | 24 months after radiation | 
| Vessel tortuosity as assessed by NIRFLI |  | immediately before surgery | 
| Vessel tortuosity as assessed by NIRFLI |  | immediately before radiation (which is 6-8 weeks after surgery) | 
| Vessel tortuosity as assessed by NIRFLI |  | 6 months after radiation | 
| Vessel tortuosity as assessed by NIRFLI |  | 12 months after radiation | 
| Vessel tortuosity as assessed by NIRFLI |  | 24 months after radiation | 
| Vessel dilation ratio as assessed by NIRFLI |  | immediately before surgery | 
| Vessel dilation ratio as assessed by NIRFLI |  | immediately before radiation (which is 6-8 weeks after surgery) | 
| Vessel dilation ratio as assessed by NIRFLI |  | 6 months after radiation | 
| Vessel dilation ratio as assessed by NIRFLI |  | 12 months after radiation | 
| Vessel dilation ratio as assessed by NIRFLI |  | 24 months after radiation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chemokine levels as assessed by bead assay |  | immediately before surgery | 
| Chemokine levels as assessed by bead assay |  | immediately before radiation (which is 6-8 weeks after surgery) | 
| Chemokine levels as assessed by bead assay |  | 6 months after radiation | 
| Chemokine levels as assessed by bead assay |  | 12 months after radiation | 
| Chemokine levels as assessed by bead assay |  | 24 months after radiation | 
| Cytokine levels as assessed by bead assay |  | immediately before surgery | 
| Cytokine levels as assessed by bead assay |  | immediately before radiation (which is 6-8 weeks after surgery) | 
| Cytokine levels as assessed by bead assay |  | 6 months after radiation | 
| Cytokine levels as assessed by bead assay |  | 12 months after radiation | 
| Cytokine levels as assessed by bead assay |  | 24 months after radiation | 
| Number of participants with autoimmune antibodies as assessed by ELISA |  | immediately before surgery | 
| Number of participants with autoimmune antibodies as assessed by ELISA |  | immediately before radiation (which is 6-8 weeks after surgery) | 
| Number of participants with autoimmune antibodies as assessed by ELISA |  | 6 months after radiation | 
| Number of participants with autoimmune antibodies as assessed by ELISA |  | 12 months after radiation | 
| Number of participants with autoimmune antibodies as assessed by ELISA |  | 24 months after radiation |