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Completed

NCT Number: NCT02949726

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Lymphatic propulsive velocity as assessed by NIRFLI

    Time frame: immediately before surgery

  2. Lymphatic propulsive velocity as assessed by NIRFLI

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

  3. Lymphatic propulsive velocity as assessed by NIRFLI

    Time frame: 6 months after radiation

  4. Lymphatic propulsive velocity as assessed by NIRFLI

    Time frame: 12 months after radiation

  5. Lymphatic propulsive velocity as assessed by NIRFLI

    Time frame: 24 months after radiation

  6. Lymphatic propulsive frequency as assessed by NIRFLI

    Time frame: immediately before surgery

  7. Lymphatic propulsive frequency as assessed by NIRFLI

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

  8. Lymphatic propulsive frequency as assessed by NIRFLI

    Time frame: 6 months after radiation

  9. Lymphatic propulsive frequency as assessed by NIRFLI

    Time frame: 12 months after radiation

  10. Lymphatic propulsive frequency as assessed by NIRFLI

    Time frame: 24 months after radiation

  11. Percent extravascular dye as assessed by NIRFLI

    Time frame: immediately before surgery

  12. Percent extravascular dye as assessed by NIRFLI

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

  13. Percent extravascular dye as assessed by NIRFLI

    Time frame: 6 months after radiation

  14. Percent extravascular dye as assessed by NIRFLI

    Time frame: 12 months after radiation

  15. Percent extravascular dye as assessed by NIRFLI

    Time frame: 24 months after radiation

  16. Vessel tortuosity as assessed by NIRFLI

    Time frame: immediately before surgery

  17. Vessel tortuosity as assessed by NIRFLI

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

  18. Vessel tortuosity as assessed by NIRFLI

    Time frame: 6 months after radiation

  19. Vessel tortuosity as assessed by NIRFLI

    Time frame: 12 months after radiation

  20. Vessel tortuosity as assessed by NIRFLI

    Time frame: 24 months after radiation

  21. Vessel dilation ratio as assessed by NIRFLI

    Time frame: immediately before surgery

  22. Vessel dilation ratio as assessed by NIRFLI

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

  23. Vessel dilation ratio as assessed by NIRFLI

    Time frame: 6 months after radiation

  24. Vessel dilation ratio as assessed by NIRFLI

    Time frame: 12 months after radiation

  25. Vessel dilation ratio as assessed by NIRFLI

    Time frame: 24 months after radiation

Secondary outcomes

  1. Chemokine levels as assessed by bead assay

    Time frame: immediately before surgery

  2. Chemokine levels as assessed by bead assay

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

  3. Chemokine levels as assessed by bead assay

    Time frame: 6 months after radiation

  4. Chemokine levels as assessed by bead assay

    Time frame: 12 months after radiation

  5. Chemokine levels as assessed by bead assay

    Time frame: 24 months after radiation

  6. Cytokine levels as assessed by bead assay

    Time frame: immediately before surgery

  7. Cytokine levels as assessed by bead assay

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

  8. Cytokine levels as assessed by bead assay

    Time frame: 6 months after radiation

  9. Cytokine levels as assessed by bead assay

    Time frame: 12 months after radiation

  10. Cytokine levels as assessed by bead assay

    Time frame: 24 months after radiation

  11. Number of participants with autoimmune antibodies as assessed by ELISA

    Time frame: immediately before surgery

  12. Number of participants with autoimmune antibodies as assessed by ELISA

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

  13. Number of participants with autoimmune antibodies as assessed by ELISA

    Time frame: 6 months after radiation

  14. Number of participants with autoimmune antibodies as assessed by ELISA

    Time frame: 12 months after radiation

  15. Number of participants with autoimmune antibodies as assessed by ELISA

    Time frame: 24 months after radiation

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • M.D. Anderson Cancer Center
  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Oct 31, 2016
Registry last updated
Dec 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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