Clinical trial · Observational
The Impact of Surgeon-Interpreted Intraoperative Margin Assessment During Breast Conserving Surgery on Postoperative Treatment
NCT07140965CI-TRIAL-00108220suspendedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): PI Request
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Breast Conserving Therapy | Procedure | — | UNRESOLVED |
| Digital Breast Tomosynthesis | Procedure | — | UNRESOLVED |
| Pegulicianine Fluorescence-Guided Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Intraoperative Margin Assessment
- description
- Utilizing Intraoperative Margin Assessment during the breast conserving surgery, using pFGS as well as DBT.
- interventionNames
- Procedure: Pegulicianine Fluorescence-Guided Surgery
- Procedure: Digital Breast Tomosynthesis
- Procedure: Breast Conserving Therapy
Primary outcomes (1)
- measure
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.