Lymphatic and Systemic Immunity Changes in Post-radiation Lymphedema Development

The University of Texas Health Science Center, Houston80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Lymphedema

Interventions

Indocyanine Green (ICG)DRUG

Near-infrared Fluorescence Lymphatic Imaging (NIRFLI) using Indocyanine Green (ICG) is used to "visualize" lymphatic vessel anatomy and function.

Near-infrared Fluorescence Lymphatic Imaging (NIRFLI)DEVICE

Near-infrared Fluorescence Lymphatic Imaging (NIRFLI) using Indocyanine Green (ICG) is used to "visualize" lymphatic vessel anatomy and function.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Outcomes

Primary Outcomes

Lymphatic propulsive velocity as assessed by NIRFLI

Time frame: immediately before surgery

Lymphatic propulsive velocity as assessed by NIRFLI

Time frame: immediately before radiation (which is 6-8 weeks after surgery)

Lymphatic propulsive velocity as assessed by NIRFLI

Time frame: 6 months after radiation

Lymphatic propulsive velocity as assessed by NIRFLI

Time frame: 12 months after radiation

Lymphatic propulsive velocity as assessed by NIRFLI

Time frame: 24 months after radiation

Lymphatic propulsive frequency as assessed by NIRFLI

Time frame: immediately before surgery

Lymphatic propulsive frequency as assessed by NIRFLI

Time frame: immediately before radiation (which is 6-8 weeks after surgery)

Lymphatic propulsive frequency as assessed by NIRFLI

Time frame: 6 months after radiation

Lymphatic propulsive frequency as assessed by NIRFLI

Time frame: 12 months after radiation

Lymphatic propulsive frequency as assessed by NIRFLI

Time frame: 24 months after radiation

Percent extravascular dye as assessed by NIRFLI

Time frame: immediately before surgery

Data from ClinicalTrials.gov

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Secondary Outcomes

Chemokine levels as assessed by bead assay

Time frame: immediately before surgery

Chemokine levels as assessed by bead assay

Time frame: immediately before radiation (which is 6-8 weeks after surgery)

Chemokine levels as assessed by bead assay

Time frame: 6 months after radiation

Chemokine levels as assessed by bead assay

Time frame: 12 months after radiation

Chemokine levels as assessed by bead assay

Time frame: 24 months after radiation

Cytokine levels as assessed by bead assay

Time frame: immediately before surgery

Cytokine levels as assessed by bead assay

Time frame: immediately before radiation (which is 6-8 weeks after surgery)

Cytokine levels as assessed by bead assay

Time frame: 6 months after radiation

Cytokine levels as assessed by bead assay

Time frame: 12 months after radiation

Cytokine levels as assessed by bead assay

Time frame: 24 months after radiation

Number of participants with autoimmune antibodies as assessed by ELISA

Time frame: immediately before surgery

Number of participants with autoimmune antibodies as assessed by ELISA

Time frame: immediately before radiation (which is 6-8 weeks after surgery)

Number of participants with autoimmune antibodies as assessed by ELISA

Time frame: 6 months after radiation

Number of participants with autoimmune antibodies as assessed by ELISA

Time frame: 12 months after radiation

Number of participants with autoimmune antibodies as assessed by ELISA

Time frame: 24 months after radiation