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

Inclusion Criteria:

• Adults ≥ 18 years of age

• Patients undergoing axillary lymph node dissection with or without lymphaticreconstruction at diagnosis

• Patients must have ICG lymphatic mapping performed prior to axillary lymph nodedissection

• 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 treatmentdoes not have the potential to interfere with the safety or efficacy assessment ofthe investigational regimen [as determined by the treating physician and approved bythe PI] may be included).

• Written informed consent obtained from the subject and the subject agrees to complywith all the study-related procedures.

• Subjects of childbearing potential (SOCBP) must have a negative pregnancy test priorto enrollment and be using an adequate method of contraception to avoid pregnancythroughout study participation to minimize the risk of pregnancy. Prior to studyenrollment, subjects of childbearing potential must be advised of the importance ofavoiding pregnancy during trial participation and the potential risk factors for anunintentional pregnancy.

• Patients must undergo a baseline physical therapy evaluation prior to axillary lymphnode dissection.

• Patients who have received neoadjuvant chemotherapy are required to see physicaltherapy for lymphedema assessment following completion of chemotherapy prior tosurgery.

Exclusion Criteria:

• Patients with history of ipsilateral breast cancer (invasive or ductal carcinoma insitu (DCIS))

• Patients with history of prior ipsilateral axillary surgery, such as excisionalbiopsy of lymph nodes or treatment of benign axillary disease processes such ashidradenitis

• Patients with history of or concurrent diagnosis of contralateral breast cancer (bilateral breast cancer)

• Patients with planned contralateral axillary surgery or history of contralateralaxillary surgery

• Patients with a history, or concurrent, malignancy of the ipsilateral upperextremity- i.e. skin cancer

• Patients with history of lymphedema or lymphatic dysmotility of the ipsilateral orcontralateral arm or are found to have lymphatic dysfunction at their pre-operativevisit

• 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) includingpacemakers incompatible for bioimpedance

• Patients with history of allergy to ICG or Iodine/Shellfish

• Patients with evidence of liver dysfunction including diagnosis of end stage liverdisease

• 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 includenodes harvested as part of sentinel lymph node biopsy

• There is a lack of description of intraoperative findings during axillary lymph nodedissection, 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 conditionthat contraindicates the use of protocol therapy or that might affect theinterpretation of the results of the study or that puts the subject at high risk fortreatment complications, in the opinion of the treating physician.

• Prisoners or subjects who are involuntarily incarcerated, or subjects who arecompulsorily detained for treatment of either a psychiatric or physical illness.