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RECRUITING
NCT06327490
PHASE2

A Study Evaluating the Feasibility and Compliance of Manual Lymphatic Drainage Comparing Indocyanine-Green (ICG) Guided vs. Traditional Guided in Patients Undergoing Axillary Node Dissection for the Treatment of Breast Cancer

Sponsor: University of Florida

View on ClinicalTrials.gov

Summary

Breast cancer is estimated to affect approximately 300,000 women in the US in 2023. Studies demonstrate that 1 in 5 will develop breast cancer related lymphedema secondary to the treatments that they receive. BCRL at this time has no cure, however early detection can prevent the progression to late stage BCRL. At this time a technique of arm massage, manual lymphatic drainage (MLD), is used for treatment. This study investigates a new method of MLD, which is guided by the individual patients' lymphatic anatomy through use of ICG-lymphography.

Official title: A Pilot Study Evaluating the Feasibility and Compliance of Manual Lymphatic Drainage Comparing Indocyanine-Green (ICG) Guided vs. Traditional Guided in Patients Undergoing Axillary Node Dissection for the Treatment of Breast Cancer

Key Details

Gender

All

Age Range

18 Years - 99 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2024-10-15

Completion Date

2028-06

Last Updated

2026-02-18

Healthy Volunteers

No

Conditions

Interventions

PROCEDURE

ICG-guided manual lymphatic drainage

Participants will perform manual lymphatic drainage on their affected arm using ICG lymphography images of the lymphatic pathway in their affected arm as guidance once daily for 2 years post-surgery.

PROCEDURE

Traditional manual lymphatic drainage

Participants will perform manual lymphatic drainage on their affected arm using traditional technique once daily for 2 years post-surgery.

DRUG

Indocyanine green

All participants will be injected with indocyanine green for lymphatic mapping of the affected upper extremity, however this mapping will only be used to guide manual lymphatic drainage for participants on the ICG-guided manual lymphatic drainage arm.

Locations (1)

University of Florida

Gainesville, Florida, United States