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
Recruiting
Phase 2
Interventional Study
Breast Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 99
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 30 (estimated)
- Sponsor
- University of Florida · Other
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About This Trial
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 tr…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Adults ≥ 18 years of age
* 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
* A clinical diagnosis consistent with stage Tis-T4N…
Contacts