Actively Recruiting
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
Led by University of Florida · Updated on 2026-02-18
30
Participants Needed
1
Research Sites
189 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years of age or older
- Patients undergoing axillary lymph node dissection with or without lymphatic reconstruction at diagnosis
- Patients must have ICG lymphatic mapping performed prior to axillary lymph node dissection
- Clinical diagnosis of stage Tis-T4N0-3M0 breast cancer
- ECOG Performance Status of 0-1
- No more than one active malignancy at enrollment (exceptions allowed if approved by physician and PI)
- Written informed consent and agreement to comply with study procedures
- Negative pregnancy test and use of contraception for subjects of childbearing potential
- Baseline physical therapy evaluation before axillary lymph node dissection
- Lymphedema assessment by physical therapy after neoadjuvant chemotherapy completion if applicable
You will not qualify if you...
- History of ipsilateral breast cancer (invasive or DCIS)
- History of prior ipsilateral axillary surgery such as lymph node biopsy or treatment of benign axillary disease
- History or concurrent diagnosis of bilateral breast cancer
- Planned or previous contralateral axillary surgery
- History or concurrent malignancy of ipsilateral upper extremity (e.g., skin cancer)
- History of lymphedema or lymphatic dysfunction in either arm
- History of upper extremity blood clots, lymphangitis, or cellulitis
- History of congestive heart failure or significant cardiac disease (NYHA Class III or higher), including incompatible pacemakers
- Evidence of liver dysfunction or end-stage liver disease
- Less than 10 lymph nodes removed without neoadjuvant chemotherapy, or less than 8 if neoadjuvant chemotherapy received
- Missing intraoperative findings documentation during axillary lymph node dissection
- Confirmed pregnancy or breastfeeding
- Any other disease or condition that contraindicates study therapy or affects result interpretation as judged by physician
- Prisoners, involuntarily incarcerated individuals, or those compulsorily detained for psychiatric or physical illness
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Florida
Gainesville, Florida, United States, 32610
Actively Recruiting
Research Team
S
Stephanie Portillo
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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