NCT02949726

Lymphatic and Systemic Immunity Changes in Post-radiation Lymphedema Development

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lymphedema

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-04-24
• Primary completion: 2022-10-01
• Completion: 2022-10-01
• First posted: 2016-10-31
• Last updated: 2023-12-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study