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Trial 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

NCT ID: NCT06327490

Condition: Breast Cancer

Conditions: Official terms:
Breast Neoplasms

Conditions: Keywords:
breast cancer-related lymphedema
ICG-Lymphography Guided Manual Lymphatic Drainage
limb volume changes

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Procedure
Intervention name: ICG-guided manual lymphatic drainage
Description: 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.
Arm group label: ICG-guided manual lymphatic drainage

Intervention type: Procedure
Intervention name: Traditional manual lymphatic drainage
Description: Participants will perform manual lymphatic drainage on their affected arm using traditional technique once daily for 2 years post-surgery.
Arm group label: Traditional manual lymphatic drainage

Intervention type: Drug
Intervention name: Indocyanine green
Description: 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.
Arm group label: ICG-guided manual lymphatic drainage

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.

Criteria for 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-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. 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 history of or concurrent malignancy of the ipsilateral or contralateral 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 history of allergy to ICG or Iodine/Shellfish - Patients with evidence of liver dysfunction including diagnosis of end stage liver disease or abnormal liver tests at pre-op workup - 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, anatomy, procedure: 1) Identification and preservation of axillary vein, long thoracic nerve, thoracodorsal nerve; 2) Complete Level I and Level II axillary dissection (with or without Level III and Rotter's node dissection at the treating surgeon's discretion). - 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.

Gender: All

Minimum age: 18 Years

Maximum age: 99 Years

Healthy volunteers: No

Locations:

Facility:
Name: University of Florida

Address:
City: Gainesville
Zip: 32610
Country: United States

Status: Recruiting

Contact:
Last name: Audrianna Macchia

Phone: 352-433-0421
Email: amacchia@ufl.edu

Investigator:
Last name: Lisa Spiguel, MD
Email: Principal Investigator

Start date: October 2024

Completion date: June 2028

Lead sponsor:
Agency: University of Florida
Agency class: Other

Source: University of Florida

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06327490

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