Lymphatic and Systemic Immunity Changes in Post-radiation Lymphedema Development

Lymphedema Clinical Trial

Official title:

Lymphatic and Systemic Immunity Changes in Post-radiation Lymphedema Development

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02949726
• Other study ID #: HSC-MS-15-1021
• Secondary ID: 1R01CA201487-01A
• Status: Completed
• Phase: Phase 1
• Start date: April 24, 2017
• Est. completion date: October 1, 2022

Study information

• Verified date: December 2023
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 1, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Lymphedema

Intervention

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.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (3)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	M.D. Anderson Cancer Center, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lymphatic propulsive velocity as assessed by NIRFLI		immediately before surgery
Primary	Lymphatic propulsive velocity as assessed by NIRFLI		immediately before radiation (which is 6-8 weeks after surgery)
Primary	Lymphatic propulsive velocity as assessed by NIRFLI		6 months after radiation
Primary	Lymphatic propulsive velocity as assessed by NIRFLI		12 months after radiation
Primary	Lymphatic propulsive velocity as assessed by NIRFLI		24 months after radiation
Primary	Lymphatic propulsive frequency as assessed by NIRFLI		immediately before surgery
Primary	Lymphatic propulsive frequency as assessed by NIRFLI		immediately before radiation (which is 6-8 weeks after surgery)
Primary	Lymphatic propulsive frequency as assessed by NIRFLI		6 months after radiation
Primary	Lymphatic propulsive frequency as assessed by NIRFLI		12 months after radiation
Primary	Lymphatic propulsive frequency as assessed by NIRFLI		24 months after radiation
Primary	Percent extravascular dye as assessed by NIRFLI		immediately before surgery
Primary	Percent extravascular dye as assessed by NIRFLI		immediately before radiation (which is 6-8 weeks after surgery)
Primary	Percent extravascular dye as assessed by NIRFLI		6 months after radiation
Primary	Percent extravascular dye as assessed by NIRFLI		12 months after radiation
Primary	Percent extravascular dye as assessed by NIRFLI		24 months after radiation
Primary	Vessel tortuosity as assessed by NIRFLI		immediately before surgery
Primary	Vessel tortuosity as assessed by NIRFLI		immediately before radiation (which is 6-8 weeks after surgery)
Primary	Vessel tortuosity as assessed by NIRFLI		6 months after radiation
Primary	Vessel tortuosity as assessed by NIRFLI		12 months after radiation
Primary	Vessel tortuosity as assessed by NIRFLI		24 months after radiation
Primary	Vessel dilation ratio as assessed by NIRFLI		immediately before surgery
Primary	Vessel dilation ratio as assessed by NIRFLI		immediately before radiation (which is 6-8 weeks after surgery)
Primary	Vessel dilation ratio as assessed by NIRFLI		6 months after radiation
Primary	Vessel dilation ratio as assessed by NIRFLI		12 months after radiation
Primary	Vessel dilation ratio as assessed by NIRFLI		24 months after radiation
Secondary	Chemokine levels as assessed by bead assay		immediately before surgery
Secondary	Chemokine levels as assessed by bead assay		immediately before radiation (which is 6-8 weeks after surgery)
Secondary	Chemokine levels as assessed by bead assay		6 months after radiation
Secondary	Chemokine levels as assessed by bead assay		12 months after radiation
Secondary	Chemokine levels as assessed by bead assay		24 months after radiation
Secondary	Cytokine levels as assessed by bead assay		immediately before surgery
Secondary	Cytokine levels as assessed by bead assay		immediately before radiation (which is 6-8 weeks after surgery)
Secondary	Cytokine levels as assessed by bead assay		6 months after radiation
Secondary	Cytokine levels as assessed by bead assay		12 months after radiation
Secondary	Cytokine levels as assessed by bead assay		24 months after radiation
Secondary	Number of participants with autoimmune antibodies as assessed by ELISA		immediately before surgery
Secondary	Number of participants with autoimmune antibodies as assessed by ELISA		immediately before radiation (which is 6-8 weeks after surgery)
Secondary	Number of participants with autoimmune antibodies as assessed by ELISA		6 months after radiation
Secondary	Number of participants with autoimmune antibodies as assessed by ELISA		12 months after radiation
Secondary	Number of participants with autoimmune antibodies as assessed by ELISA		24 months after radiation