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

NCT07140965 | Suspended

• 2 other identifiers: 2025-0648NCI-2025-06199
• Study Type: observational
• Target: 175
• Locations: 1 country
• Sites: 1

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 margins during a partial mastectomy and decrease the need for a second surgery.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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

  Through study completion; an average of 1 year.

Study Arms (1)

Intraoperative Margin Assessment

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

Procedure: Pegulicianine Fluorescence-Guided Surgery; Procedure: Digital Breast Tomosynthesis; Procedure: Breast Conserving Therapy

Interventions

Pegulicianine Fluorescence-Guided Surgery PROCEDURE

Given by Surgery

Intraoperative Margin Assessment

Digital Breast Tomosynthesis PROCEDURE

Given by Procedure

Intraoperative Margin Assessment

Breast Conserving Therapy PROCEDURE

Given by Procedure

Intraoperative Margin Assessment

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

MD Anderson Cancer Center

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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Mastectomy, Segmental

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Mastectomy; Surgical Procedures, Operative

Study Officials

• Fedra Fallahian, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2025
• First Posted: August 26, 2025
• Study Start: October 9, 2025
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2029
• Last Updated: April 14, 2026

Record last verified: 2026-04

Locations

US (1)