PI Request

To learn if Pegulicianine Fluorescence-Guided Surgery (pFGS), which is part of the Lumicell Direct Visualization System, and Digital Breast Tomosynthesis (DBT) can improve the identification of tumor margins during a partial mastectomy and decrease the need for a second surgery.

Primary Objectives:

-To determine if surgeon interpretation of pFGS and DBT has a higher specificity compared to SEP, resulting in fewer excisions of additional tissue unnecessarily

Secondary Objectives:

• To determine if surgeon evaluation of segmental mastectomy margins using pFGS and DBT is associated with better patient- and physician-reported cosmesis
• To determine if surgeon interpretation of pFGS and DBT results in a lower rate of positive margins after BCS compared to SEP
• To determine if surgeon interpretation of pFGS and DBT has a shorter operative time compared to SEP.
• To determine if surgeon interpretation of pFGS and DBT results in less delays in receipt of adjuvant treatment and the reduction of targeted volume of radiation therapy or omission of radiation altogether

Inclusion Criteria:

• We plan to enroll 175 patients.
• Women aged 18 years or older with a breast cancer diagnosis at any stage who will undergo a segmental mastectomy, regardless of receipt of neoadjuvant therapy.

Exclusion Criteria:

1. Multi-site segmental mastectomies within the same breast
2. Participants without a cancer diagnosis
3. Participants from vulnerable populations including minors, pregnant women, and/or cognitively impaired adults.

MD Anderson Cancer Center