Status:
ACTIVE_NOT_RECRUITING
The Impact of Surgeon-Interpreted Intraoperative Margin Assessment During Breast Conserving Surgery on Postoperative Treatment
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Brief 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 ...
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 Object...
Eligibility Criteria
Inclusion
- 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
- Multi-site segmental mastectomies within the same breast
- Participants without a cancer diagnosis
- Participants from vulnerable populations including minors, pregnant women, and/or cognitively impaired adults.
Key Trial Info
Start Date :
October 9 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 30 2029
Estimated Enrollment :
175 Patients enrolled
Trial Details
Trial ID
NCT07140965
Start Date
October 9 2025
End Date
September 30 2029
Last Update
October 22 2025
Active Locations (1)
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1
MD Anderson Cancer Center
Houston, Texas, United States, 77030