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Trial record 7 of 77 for:    Recruiting, Not yet recruiting, Available Studies | "Lymphedema"

Lymphatic and Systemic Immunity Changes in Post-radiation Lymphedema Development

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ClinicalTrials.gov Identifier: NCT02949726
Recruitment Status : Recruiting
First Posted : October 31, 2016
Last Update Posted : May 4, 2017
Sponsor:
Collaborators:
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Melissa B Aldrich, The University of Texas Health Science Center, Houston

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.

Condition or disease Intervention/treatment Phase
Lymphedema Drug: Indocyanine Green (ICG) Device: Near-infrared Fluorescence Lymphatic Imaging (NIRFLI) Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Lymphatic and Systemic Immunity Changes in Post-radiation Lymphedema Development
Actual Study Start Date : April 24, 2017
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphedema

Arm Intervention/treatment
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02949726


Contacts
Contact: Melissa B Aldrich, PhD 713-248-2642 Melissa.B.Aldrich@uth.tmc.edu

Locations
United States, Texas
The University of Texas Health Science Center at Houston Recruiting
Houston, Texas, United States, 77030
Contact: Melissa B Aldrich, PhD    713-248-2642    Melissa.B.Aldrich@uth.tmc.edu   
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Melissa B Aldrich, PhD The University of Texas Health Science Center, Houston

Responsible Party: Melissa B Aldrich, Assistant Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT02949726     History of Changes
Other Study ID Numbers: HSC-MS-15-1021
1R01CA201487-01A1 ( U.S. NIH Grant/Contract )
First Posted: October 31, 2016    Key Record Dates
Last Update Posted: May 4, 2017
Last Verified: May 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes

Additional relevant MeSH terms:
Lymphedema
Lymphatic Diseases