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Lymphatic and Systemic Immunity Changes in Post-radiation Lymphedema Development

Primary Purpose

Lymphedema

Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Indocyanine Green (ICG)
Near-infrared Fluorescence Lymphatic Imaging (NIRFLI)
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Lymphedema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • The University of Texas Health Science Center at Houston

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Cancer-treated patients receiving NIRFLI

Arm Description

Near-infrared Fluorescence Lymphatic Imaging (NIRFLI) using Indocyanine Green (ICG) is used to "visualize" lymphatic vessel anatomy and function.

Outcomes

Primary Outcome Measures

Lymphatic propulsive velocity as assessed by NIRFLI
Lymphatic propulsive velocity as assessed by NIRFLI
Lymphatic propulsive velocity as assessed by NIRFLI
Lymphatic propulsive velocity as assessed by NIRFLI
Lymphatic propulsive velocity as assessed by NIRFLI
Lymphatic propulsive frequency as assessed by NIRFLI
Lymphatic propulsive frequency as assessed by NIRFLI
Lymphatic propulsive frequency as assessed by NIRFLI
Lymphatic propulsive frequency as assessed by NIRFLI
Lymphatic propulsive frequency as assessed by NIRFLI
Percent extravascular dye as assessed by NIRFLI
Percent extravascular dye as assessed by NIRFLI
Percent extravascular dye as assessed by NIRFLI
Percent extravascular dye as assessed by NIRFLI
Percent extravascular dye as assessed by NIRFLI
Vessel tortuosity as assessed by NIRFLI
Vessel tortuosity as assessed by NIRFLI
Vessel tortuosity as assessed by NIRFLI
Vessel tortuosity as assessed by NIRFLI
Vessel tortuosity as assessed by NIRFLI
Vessel dilation ratio as assessed by NIRFLI
Vessel dilation ratio as assessed by NIRFLI
Vessel dilation ratio as assessed by NIRFLI
Vessel dilation ratio as assessed by NIRFLI
Vessel dilation ratio as assessed by NIRFLI

Secondary Outcome Measures

Chemokine levels as assessed by bead assay
Chemokine levels as assessed by bead assay
Chemokine levels as assessed by bead assay
Chemokine levels as assessed by bead assay
Chemokine levels as assessed by bead assay
Cytokine levels as assessed by bead assay
Cytokine levels as assessed by bead assay
Cytokine levels as assessed by bead assay
Cytokine levels as assessed by bead assay
Cytokine levels as assessed by bead assay
Number of participants with autoimmune antibodies as assessed by ELISA
Number of participants with autoimmune antibodies as assessed by ELISA
Number of participants with autoimmune antibodies as assessed by ELISA
Number of participants with autoimmune antibodies as assessed by ELISA
Number of participants with autoimmune antibodies as assessed by ELISA

Full Information

First Posted
July 11, 2016
Last Updated
May 9, 2023
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
M.D. Anderson Cancer Center, National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02949726
Brief Title
Lymphatic and Systemic Immunity Changes in Post-radiation Lymphedema Development
Official Title
Lymphatic and Systemic Immunity Changes in Post-radiation Lymphedema Development
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 24, 2017 (Actual)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
M.D. Anderson Cancer Center, National Cancer Institute (NCI)

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphedema

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cancer-treated patients receiving NIRFLI
Arm Type
Other
Arm Description
Near-infrared Fluorescence Lymphatic Imaging (NIRFLI) using Indocyanine Green (ICG) is used to "visualize" lymphatic vessel anatomy and function.
Intervention Type
Drug
Intervention Name(s)
Indocyanine Green (ICG)
Intervention Description
Near-infrared Fluorescence Lymphatic Imaging (NIRFLI) using Indocyanine Green (ICG) is used to "visualize" lymphatic vessel anatomy and function.
Intervention Type
Device
Intervention Name(s)
Near-infrared Fluorescence Lymphatic Imaging (NIRFLI)
Intervention Description
Near-infrared Fluorescence Lymphatic Imaging (NIRFLI) using Indocyanine Green (ICG) is used to "visualize" lymphatic vessel anatomy and function.
Primary Outcome Measure Information:
Title
Lymphatic propulsive velocity as assessed by NIRFLI
Time Frame
immediately before surgery
Title
Lymphatic propulsive velocity as assessed by NIRFLI
Time Frame
immediately before radiation (which is 6-8 weeks after surgery)
Title
Lymphatic propulsive velocity as assessed by NIRFLI
Time Frame
6 months after radiation
Title
Lymphatic propulsive velocity as assessed by NIRFLI
Time Frame
12 months after radiation
Title
Lymphatic propulsive velocity as assessed by NIRFLI
Time Frame
24 months after radiation
Title
Lymphatic propulsive frequency as assessed by NIRFLI
Time Frame
immediately before surgery
Title
Lymphatic propulsive frequency as assessed by NIRFLI
Time Frame
immediately before radiation (which is 6-8 weeks after surgery)
Title
Lymphatic propulsive frequency as assessed by NIRFLI
Time Frame
6 months after radiation
Title
Lymphatic propulsive frequency as assessed by NIRFLI
Time Frame
12 months after radiation
Title
Lymphatic propulsive frequency as assessed by NIRFLI
Time Frame
24 months after radiation
Title
Percent extravascular dye as assessed by NIRFLI
Time Frame
immediately before surgery
Title
Percent extravascular dye as assessed by NIRFLI
Time Frame
immediately before radiation (which is 6-8 weeks after surgery)
Title
Percent extravascular dye as assessed by NIRFLI
Time Frame
6 months after radiation
Title
Percent extravascular dye as assessed by NIRFLI
Time Frame
12 months after radiation
Title
Percent extravascular dye as assessed by NIRFLI
Time Frame
24 months after radiation
Title
Vessel tortuosity as assessed by NIRFLI
Time Frame
immediately before surgery
Title
Vessel tortuosity as assessed by NIRFLI
Time Frame
immediately before radiation (which is 6-8 weeks after surgery)
Title
Vessel tortuosity as assessed by NIRFLI
Time Frame
6 months after radiation
Title
Vessel tortuosity as assessed by NIRFLI
Time Frame
12 months after radiation
Title
Vessel tortuosity as assessed by NIRFLI
Time Frame
24 months after radiation
Title
Vessel dilation ratio as assessed by NIRFLI
Time Frame
immediately before surgery
Title
Vessel dilation ratio as assessed by NIRFLI
Time Frame
immediately before radiation (which is 6-8 weeks after surgery)
Title
Vessel dilation ratio as assessed by NIRFLI
Time Frame
6 months after radiation
Title
Vessel dilation ratio as assessed by NIRFLI
Time Frame
12 months after radiation
Title
Vessel dilation ratio as assessed by NIRFLI
Time Frame
24 months after radiation
Secondary Outcome Measure Information:
Title
Chemokine levels as assessed by bead assay
Time Frame
immediately before surgery
Title
Chemokine levels as assessed by bead assay
Time Frame
immediately before radiation (which is 6-8 weeks after surgery)
Title
Chemokine levels as assessed by bead assay
Time Frame
6 months after radiation
Title
Chemokine levels as assessed by bead assay
Time Frame
12 months after radiation
Title
Chemokine levels as assessed by bead assay
Time Frame
24 months after radiation
Title
Cytokine levels as assessed by bead assay
Time Frame
immediately before surgery
Title
Cytokine levels as assessed by bead assay
Time Frame
immediately before radiation (which is 6-8 weeks after surgery)
Title
Cytokine levels as assessed by bead assay
Time Frame
6 months after radiation
Title
Cytokine levels as assessed by bead assay
Time Frame
12 months after radiation
Title
Cytokine levels as assessed by bead assay
Time Frame
24 months after radiation
Title
Number of participants with autoimmune antibodies as assessed by ELISA
Time Frame
immediately before surgery
Title
Number of participants with autoimmune antibodies as assessed by ELISA
Time Frame
immediately before radiation (which is 6-8 weeks after surgery)
Title
Number of participants with autoimmune antibodies as assessed by ELISA
Time Frame
6 months after radiation
Title
Number of participants with autoimmune antibodies as assessed by ELISA
Time Frame
12 months after radiation
Title
Number of participants with autoimmune antibodies as assessed by ELISA
Time Frame
24 months after radiation

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melissa B Aldrich, PhD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

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Lymphatic and Systemic Immunity Changes in Post-radiation Lymphedema Development

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