Lymphatic and Systemic Immunity Changes in Post-radiation Lymphedema Development

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 Overview

• Status: Completed
• Conditions: Lymphedema
• Intervention / Treatment: Drug: Indocyanine Green (ICG); Device: Near-infrared Fluorescence Lymphatic Imaging (NIRFLI)

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: M.D. Anderson Cancer Center; National Cancer Institute (NCI)
• Investigators: Principal Investigator: Melissa B Aldrich, PhD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2017
• Primary Completion (Actual): October 1, 2022
• Study Completion (Actual): October 1, 2022

Study Registration Dates

• First Submitted: July 11, 2016
• First Submitted That Met QC Criteria: October 27, 2016
• First Posted (Estimated): October 31, 2016

Study Record Updates

• Last Update Posted (Estimated): December 14, 2023
• Last Update Submitted That Met QC Criteria: December 12, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lymphatic Diseases; Lymphedema
• Other Study ID Numbers: HSC-MS-15-1021; 1R01CA201487-01A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes