The Impact of Surgeon-Interpreted Intraoperative Margin Assessment During Breast Conserving Surgery on Postoperative Treatment
NCT07140965 · Status: SUSPENDED · Type: OBSERVATIONAL · Enrollment: 175
Last updated 2026-04-14
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.
Conditions
Interventions
- PROCEDURE
-
Pegulicianine Fluorescence-Guided Surgery
Given by Surgery
- PROCEDURE
-
Digital Breast Tomosynthesis
Given by Procedure
- PROCEDURE
-
Breast Conserving Therapy
Given by Procedure
Sponsors & Collaborators
-
M.D. Anderson Cancer Center
lead OTHER
Principal Investigators
-
Fedra Fallahian, MD · M.D. Anderson Cancer Center
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-10-09
- Primary Completion
- 2027-09-30
- Completion
- 2029-09-30
Countries
- United States
Study Locations
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