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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

StatusRecruiting
PhasePhase 2
Started2024-10-15
View on ClinicalTrials.gov ↗

Amendment history

2026-09-08
Study Status, Contacts/Locations v9
Study sitescontacts updated at 1 of 1 site
2026-02-16
Study Status, Eligibility, Contacts/Locations v8
Eligibility criteria-60 characters
[...] disease) including pacemakers incompatible for bioimpedance Patients with history of allergy to ICG or Iodine/Shellfish Patients with evidence of liver dysfunction including diagno [...]
Study sitescontacts updated at 1 of 1 site
2025-05-05
Study Status, Eligibility v7
Eligibility criteriarevised
[...] 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 bre [...] sy There is a lack of description of intraoperative findings, anatomy, procedure: 1) Identification and preservation ofduring axillary vein, long thoracic nerve, thoracodorsal nerve; 2) Complete Level I and Level II axillary dissection (with or without Level III and Rotter'slymph node dissection, atsuch as th [...] [...]
2025-03-04
Study Status, Contacts/Locations v6
Study sitescontacts updated at 1 of 1 site
2024-11-12
Study Status, Eligibility, Contacts/Locations v5
Start dateestimated 2024-10→confirmed 2024-10-15
Eligibility criteria-57 characters
[...] or history of contralateral axillary surgery Patients with a history of, or concurrent, malignancy of the ipsilateral or contralateral upper extremity- i.e. skin cancer Patients with history of [...] r 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 neoadj [...]
Study sitescontacts updated at 1 of 1 site
Show 4 earlier versions
2024-09-11
Not Yet Recruiting→Recruiting Study Status, Eligibility, Contacts/Locations v4
Trial statusNot Yet Recruiting→Recruiting
Start date2024-08→2024-10
Eligibility criteria+703 characters
[...] ction 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 brea [...] ymphatic 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, lympha [...] tage 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. [...] [...]
Study sitesdetails revised at 1 of 1 site
2024-07-24
Study Status v3
Start date2024-06→2024-08
2024-06-05
Study Identification, Study Status, Oversight, Study Design, Arms and Interventions v2
PhaseNot applicable→Phase 2
InterventionsICG-guided manual lymphatic drainage (Procedure), Traditional manual lymphatic drainage (Procedure)→ICG-guided manual lymphatic drainage (Procedure), Indocyanine green (Drug), Traditional manual lymphatic drainage (Procedure)
2024-04-18
Study Status, Outcome Measures v1
Secondary endpoints5 entries, revised
Breast cancer related lymphedema symtomssymptoms
2024-03-18
Original filing
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.
Trial Details
NCT Number NCT06327490
Lead Sponsor University of Florida
Conditions Breast Cancer
Enrollment 30 participants
Start Date 2024-10-15
Primary Completion 2028-06 (estimated)
Study Completion 2028-06 (estimated)
Updated on ClinicalTrials.gov 2026-09-09