Lymphedema
Conditions
Brief summary
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.
Interventions
DRUGIndocyanine Green (ICG)
Near-infrared Fluorescence Lymphatic Imaging (NIRFLI) using Indocyanine Green (ICG) is used to visualize lymphatic vessel anatomy and function.
DEVICENear-infrared Fluorescence Lymphatic Imaging (NIRFLI)
Near-infrared Fluorescence Lymphatic Imaging (NIRFLI) using Indocyanine Green (ICG) is used to visualize lymphatic vessel anatomy and function.
Sponsors
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
The University of Texas Health Science Center, Houston
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vessel dilation ratio as assessed by NIRFLI | immediately before surgery |
| Lymphatic propulsive frequency as assessed by NIRFLI | immediately before surgery |
| Percent extravascular dye as assessed by NIRFLI | immediately before surgery |
| Vessel tortuosity as assessed by NIRFLI | immediately before surgery |
| Lymphatic propulsive velocity as assessed by NIRFLI | immediately before surgery |
Secondary
| Measure | Time frame |
|---|---|
| Cytokine levels as assessed by bead assay | immediately before surgery |
| Number of participants with autoimmune antibodies as assessed by ELISA | immediately before surgery |
| Chemokine levels as assessed by bead assay | immediately before surgery |
Countries
United States
Outcome results
None listed