Lymphedema Prevention Through Immediate Lymphatic Reconstruction (LILY) Trial.

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.

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.