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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

175 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-10-09

Study Completion Date

2029-09-30

Brief Summary

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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.

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Detailed Description

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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

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Intraoperative Margin Assessment

Utilizing Intraoperative Margin Assessment during the breast conserving surgery, using pFGS as well as DBT.

Pegulicianine Fluorescence-Guided Surgery

Intervention Type PROCEDURE

Given by Surgery

Digital Breast Tomosynthesis

Intervention Type PROCEDURE

Given by Procedure

Breast Conserving Therapy

Intervention Type PROCEDURE

Given by Procedure

Interventions

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Pegulicianine Fluorescence-Guided Surgery

Given by Surgery

Intervention Type PROCEDURE

Digital Breast Tomosynthesis

Given by Procedure

Intervention Type PROCEDURE

Breast Conserving Therapy

Given by Procedure

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

1. Multi-site segmental mastectomies within the same breast
2. Participants without a cancer diagnosis
3. Participants from vulnerable populations including minors, pregnant women, and/or cognitively impaired adults.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No