Overview
To learn if reconstruction of the lymphatic system at the time of axillary lymphadenectomy can reduce the risk of developing lymphedema.
Description
Primary Objectives
- To determine the freedom from lymphedema (FFL) rate at 2 years postoperatively in participants with a diagnosis of IBC undergoing ILR at the time of ALND.
Secondary Objectives
- Estimate the proportion of participants who have lymphedema that persists at 2 years after ILR surgeries.
- Determine baseline lymphatic vessel anatomical or functional characteristics associated with increased risk of lymphedema following ILR.
- Evaluate changes in systemic inflammatory mediators and systemic immune cell function affiliated with lymphedema development.
Eligibility
Inclusion Criteria:
- Participants diagnosed with IBC.
- Participants who have been scheduled for ILR/pLVB by their treating physician/surgeon at the time of their axillary lymphadenectomy for breast cancer
- Participants willing and able to comply with the study protocol requirements and all study-related visit requirements.
- Female subjects at least 18 years old and capable of providing consent to participate.
- Females of childbearing potential must have a negative urine pregnancy test within 36 hours prior to study drug administration and agree to use a medically accepted method of contraception for a period of one month following the study.
Exclusion Criteria:
- Patients known to be pregnant or breast-feeding.
- Patients with known or suspected iodine or ICG hypersensitivity.
- Patients unable to remain stationary for one hour.
- Active cellulitis.
- Subjects with a preoperative clinical lymphedema diagnosis.
- Subjects undergoing bilateral ALND.
- Subjects requiring immediate chest wall reconstruction with a pedicled or microvascular flap, or those that have received preoperative radiation therapy.
- Patients with BMI >45kg/m2.