SuspendedNot Applicable

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

Stopped: PI Request

United States175 participantsStarted 2025-10-09

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

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Exclusion criteria

✕. 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.

What they're measuring

safety and adverse events (AEs). Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 6.0

Timeframe: Through study completion; an average of 1 year.

Trial details

NCT IDNCT07140965

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-09-30

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