NCT07140965

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

• Status: Suspended
• Phase: —
• Study type: Observational
• Enrollment: 175 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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

Conditions

• Breast Cancer

Interventions

Type	Name	Description
PROCEDURE	Pegulicianine Fluorescence-Guided Surgery	Given by Surgery
PROCEDURE	Digital Breast Tomosynthesis	Given by Procedure
PROCEDURE	Breast Conserving Therapy	Given by Procedure

Timeline

• Start date: 2025-10-09
• Primary completion: 2027-09-30
• Completion: 2029-09-30
• First posted: 2025-08-26
• Last updated: 2026-04-14

Locations

1 site across 1 country: United States