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Lymphatic and Systemic Immunity Changes in Post-radiation Lymphedema Development

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02949726
Recruitment Status : Recruiting
First Posted : October 31, 2016
Last Update Posted : November 3, 2020
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

Tracking Information
First Submitted Date  ICMJE July 11, 2016
First Posted Date  ICMJE October 31, 2016
Last Update Posted Date November 3, 2020
Actual Study Start Date  ICMJE April 24, 2017
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 27, 2016)
  • 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 ]
  • Percent extravascular dye as assessed by NIRFLI [ Time Frame: immediately before radiation (which is 6-8 weeks after surgery) ]
  • Percent extravascular dye as assessed by NIRFLI [ Time Frame: 6 months after radiation ]
  • Percent extravascular dye as assessed by NIRFLI [ Time Frame: 12 months after radiation ]
  • Percent extravascular dye as assessed by NIRFLI [ Time Frame: 24 months after radiation ]
  • Vessel tortuosity as assessed by NIRFLI [ Time Frame: immediately before surgery ]
  • Vessel tortuosity as assessed by NIRFLI [ Time Frame: immediately before radiation (which is 6-8 weeks after surgery) ]
  • Vessel tortuosity as assessed by NIRFLI [ Time Frame: 6 months after radiation ]
  • Vessel tortuosity as assessed by NIRFLI [ Time Frame: 12 months after radiation ]
  • Vessel tortuosity as assessed by NIRFLI [ Time Frame: 24 months after radiation ]
  • Vessel dilation ratio as assessed by NIRFLI [ Time Frame: immediately before surgery ]
  • Vessel dilation ratio as assessed by NIRFLI [ Time Frame: immediately before radiation (which is 6-8 weeks after surgery) ]
  • Vessel dilation ratio as assessed by NIRFLI [ Time Frame: 6 months after radiation ]
  • Vessel dilation ratio as assessed by NIRFLI [ Time Frame: 12 months after radiation ]
  • Vessel dilation ratio as assessed by NIRFLI [ Time Frame: 24 months after radiation ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 27, 2016)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lymphatic and Systemic Immunity Changes in Post-radiation Lymphedema Development
Official Title  ICMJE Lymphatic and Systemic Immunity Changes in Post-radiation Lymphedema Development
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Lymphedema
Intervention  ICMJE
  • 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.
Study Arms  ICMJE Cancer-treated patients receiving NIRFLI
Near-infrared Fluorescence Lymphatic Imaging (NIRFLI) using Indocyanine Green (ICG) is used to "visualize" lymphatic vessel anatomy and function.
Interventions:
  • Drug: Indocyanine Green (ICG)
  • Device: Near-infrared Fluorescence Lymphatic Imaging (NIRFLI)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 27, 2016)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2022
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Melissa B Aldrich, PhD 713-248-2642 Melissa.B.Aldrich@uth.tmc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02949726
Other Study ID Numbers  ICMJE HSC-MS-15-1021
1R01CA201487-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Melissa B Aldrich, The University of Texas Health Science Center, Houston
Study Sponsor  ICMJE The University of Texas Health Science Center, Houston
Collaborators  ICMJE
  • M.D. Anderson Cancer Center
  • National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Melissa B Aldrich, PhD The University of Texas Health Science Center, Houston
PRS Account The University of Texas Health Science Center, Houston
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP