The Impact of Surgeon-Interpreted Intraoperative Margin Assessment During Breast Conserving Surgery on Postoperative Treatment

M.D. Anderson Cancer Center

Status: Active, not recruiting

Conditions: Breast Cancer

Treatments: Procedure: Pegulicianine Fluorescence-Guided Surgery; Procedure: Digital Breast Tomosynthesis; Procedure: Breast Conserving Therapy

Study type: Observational

Funder types: Other

Identifiers

NCT07140965

NCI-2025-06199 (Other Identifier)

2025-0648

Details and patient eligibility

About

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.

Full description

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

Enrollment: 175 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

175 participants in 1 patient group

Intraoperative Margin Assessment

Description:

Utilizing Intraoperative Margin Assessment during the breast conserving surgery, using pFGS as well as DBT.

Treatment:

Procedure: Breast Conserving Therapy

Procedure: Digital Breast Tomosynthesis

Procedure: Pegulicianine Fluorescence-Guided Surgery