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Compares treatment options for Breast Cancer
Official 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
ClinicalTrials.gov ID: NCT06327490
What this study is testing
What is Indocyanine green?
Indocyanine green is an investigational medicine, being studied as a potential treatment for breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 99
You may be able to join if
- 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
You likely can't join if
- 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...
- 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...
See the full eligibility 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
- people must not have more than one active malignancy at the time of enrollment (people with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or...
- Written informed consent obtained from the subject and the subject agrees to comply with all the study-related procedures.
- people 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...
- 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.
- 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...
- Prisoners or people who are involuntarily incarcerated, or people who are compulsorily detained for treatment of either a psychiatric or physical illness.
The study team makes the final eligibility decision.
Where it's taking place
- Gainesville, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gainesville, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.