Clinical trial · Interventional
Evaluation of Breast Cancer Surgical Margins Using Optical Spectroscopy
A Pilot Study of Intraoperative Margin Assessment Comparing Optical Spectroscopy and Frozen Section Analysis for Ductal Carcinoma In Situ of the Breast
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study will apply optical spectroscopy to intraoperative margin assessment during surgery for breast cancer. We hypothesize that a combination of fluorescence spectroscopy and diffuse reflectance spectroscopy will reliably detect involved surgical margins. Twenty patients with ductal carcinoma in-situ will undergo a standard lumpectomy followed by scanning with a sterile optical spectroscopy probe. Frozen sections from the surgical cavity will be used to evaluate the margins. Optical spectroscopy data will be categorized as benign or malignant using a statistical algorithm and the results will be compared with the frozen and permanent section results.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fluorescence spectroscopy and diffuse spectroscopy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- The goal of this research is to develop a minimally invasive technology with the capability of rapidly assessing surgical margins for breast cancer patients undergoing breast conserving therapy.
Secondary outcomes (3)
- measure
- Two potential benefits from developing this technology are:
- measure
- 1. Decreasing operative times by eliminating the need to wait for histologic margin assessment.
- measure
- 2 Intraoperative margin assessment will become available for surgeons performing breast conserving therapy in facilities in-house pathologists.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * ductal carcinoma in-situ or invasive carcinoma diagnosed by image directed core biopsy who are planning to undergo breast conserving surgery Exclusion Criteria: * patients who were diagnosed with excisional biopsy and patients undergoing mastectomy
References
Publications (0)
Data not yet available