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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Procedure: ICG-guided manual lymphatic drainage; Procedure: Traditional manual lymphatic drainage; Drug: Indocyanine green

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Stephanie Portillo; Phone Number: 352-273-3650; Email: portillos@ufl.edu

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • Recruiting
      • University of Florida
      • Principal Investigator: Lisa Spiguel, MD
      • Contact: Stephanie Portillo; Phone Number: 352-273-3650; Email: portillos@ufl.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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-T4N0-3M0 breast cancer.
• ECOG Performance Status of 0-1
• Subjects must not have more than one active malignancy at the time of enrollment (Subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen [as determined by the treating physician and approved by the PI] may be included).
• Written informed consent obtained from the subject and the subject agrees to comply with all the study-related procedures.
• Subjects of childbearing potential (SOCBP) must have a negative pregnancy test prior to enrollment and be using an adequate method of contraception to avoid pregnancy throughout study participation to minimize the risk of pregnancy. Prior to study enrollment, subjects of childbearing potential must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy.
• Patients must undergo a baseline physical therapy evaluation prior to axillary lymph node dissection.
• Patients who have received neoadjuvant chemotherapy are required to see physical therapy for lymphedema assessment following completion of chemotherapy prior to surgery.

Exclusion Criteria:

• Patients with history of ipsilateral breast cancer (invasive or ductal carcinoma in situ (DCIS))
• Patients with history of prior ipsilateral axillary surgery, such as excisional biopsy of lymph nodes or treatment of benign axillary disease processes such as hidradenitis
• Patients with history of or concurrent diagnosis of contralateral breast cancer (bilateral breast cancer)
• Patients with planned contralateral axillary surgery or history of contralateral axillary surgery
• Patients with a history, or concurrent, malignancy of the ipsilateral upper extremity- i.e. skin cancer
• Patients with history of lymphedema or lymphatic dysmotility of the ipsilateral or contralateral arm or are found to have lymphatic dysfunction at their pre-operative visit
• Patients with history of upper extremity blood clot, lymphangitis/cellulitis
• Patients with history of congestive heart failure or significant cardiac disease (such as New York Heart Association Class III or greater cardiac disease) including pacemakers incompatible for bioimpedance
• Patients with evidence of liver dysfunction including diagnosis of end stage liver disease
• Patients with less than 10 lymph nodes removed if no neoadjuvant chemotherapy (NAC) received, or less than 8 lymph nodes if NAC received. These node counts include nodes harvested as part of sentinel lymph node biopsy
• There is a lack of description of intraoperative findings during axillary lymph node dissection, such as the absence of notes on anatomy and procedure.
• Patients who are confirmed to be pregnant or breastfeeding.
• History of any other disease, metabolic dysfunction, clinical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or that might affect the interpretation of the results of the study or that puts the subject at high risk for treatment complications, in the opinion of the treating physician.
• Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ICG-guided manual lymphatic drainage	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.; 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.
Active Comparator: Traditional manual lymphatic drainage	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject compliance	Determine subject compliance rate with daily manual lymphatic drainage regimen. A subject is considered to be compliant if they perform manual lymphatic drainage at least 3 days/week.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relative volume change	Determine if patients undergoing ICG-guided MLD as compared to patients undergoing traditional MLD demonstrate reduced relative volume changes of the affected limb. The volume of the affected limb will be measured by circumferential limb measurements. These limb measurements will then be calculated into volume using conic geometry.	2 years
Bioimpedance	Determine if patients undergoing ICG-guided MLD as compared to patients undergoing traditional MLD demonstrate lower rates of increased bioimpedance. Bioimpedance will be measured using both the sozo and in-body device methods.	2 years
Incidence of progression to late stage breast cancer related lymphedema	Compare the incidence of progression to late stage breast cancer related lymphedema in both arms	2 years
Health-related quality of life	Compare health-related quality of life, as measured by the Lymphedema Life Impact Scale questionnaire, in both arms.	2 years
Breast cancer related lymphedema symptoms	Determine if patients undergoing ICG-guided MLD as compared to patients undergoing traditional MLD demonstrate lower rates of breast cancer related lymphedema symptoms. Breast cancer related lymphedema symptoms will be assessed by the Lymphedema Life Impact Scale questionnaire.	2 years

Collaborators and Investigators

• Sponsor: University of Florida
• Investigators: Principal Investigator: Lisa Spiguel, MD, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2024
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: March 18, 2024
• First Submitted That Met QC Criteria: March 18, 2024
• First Posted (Actual): March 25, 2024

Study Record Updates

• Last Update Posted (Actual): February 18, 2026
• Last Update Submitted That Met QC Criteria: February 16, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: breast cancer-related lymphedema; ICG-Lymphography Guided Manual Lymphatic Drainage; limb volume changes
• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Lymphatic Diseases; Lymphedema; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Hemic and Lymphatic Diseases; Breast Cancer Lymphedema; Breast Neoplasms; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indoles; Indocyanine Green
• Other Study ID Numbers: UF-BRE-012; IRB202400626 (Other Identifier: University of Florida); OCR44989 (Other Identifier: University of Florida)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No