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

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Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT07140965

Run by

M.D. Anderson Cancer Center

People needed

175

Starts

2025-10-09

Expected to finish

2029-09-30

Last updated by the study team

2026-04-14

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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