Clinical trial · Interventional
Breast Cancer Margin Delineation Using Polarization Subtraction Imaging Technology
Breast Cancer Margin Delineation Using Polarization Subtraction Imaging Technology: An Ex-vivo Pilot Study of Real-time Breast Margin Imaging in Women Undergoing Breast Conservation Surgery for Early Stage Breast Cancer
- 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 evaluate LumaScan, an innovative polarization microscope for real time, intraoperative imaging and evaluation of the surface of excised tissue excised during Breast Conservation Surgery (BCS) for non invasive and invasive breast cancer. The investigators hypothesis is that LumaScan will be comparable for cancer detection to conventional histopathologic evaluation of the same areas of breast tissue. The real time, intraoperative images provided by LumaScan will help improve BCS and lessen the need for BCS re-excision surgeries which can lead to higher cost, poor cosmetic outcomes, reduced survival rates, and loss of confidence in the tissue conservation surgery procedure.
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 |
|---|---|---|---|
| LumaScan Image Guided Surgery | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- NO_INTERVENTION
- label
- Single Arm
- description
- LumaScan Image Guided Surgery
- interventionNames
- Device: LumaScan Image Guided Surgery
Primary outcomes (1)
- measure
- Tumor areas shown on LumaScan images are the same as those shown on subsequent en-face pathology images.
- timeFrame
- From day of surgery until receipt of pathology results (upto 2 weeks)
- description
- Quantitative metrics (e.g. size or area of tumor found between the two images) will be used to to compare en-face pathology and corresponding LumaScan images from excised breast tissue margins.
Secondary outcomes (3)
- measure
- Pathologist interpretation of LumaScan images (blinded) are similar to those of histopathology images.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Women referred for breast conservation surgery following a diagnosis of invasive or in situ carcinoma of the breast by histopathology or women referred for lumpectomy due to a benign (fibroadenoma or papilloma) or high risk breast lesion(Atypical ductal hyperplasia, atypical lobular hyperplasia, lobular carcinoma in-situ, atypical papilloma). 2. 18 years of age or older. 3. Able to read or understand and give informed consent. Exclusion Criteria: 1. Patients undergoing neo-adjuvant systemic therapy. 2. Previous breast cancer and /or radiation in the operated breast. 3. Implants in the operated breast. 4. Pregnant or Lactating. 5. History of photosensitizing disease (porphyria, lupus etc.) or of allergy to methylene blue dye. 6. Recent use of photosensitizing agents such as fluoroquinolones and retinoids or patients undergoing phototherapy. 7. Participation in any other intraoperative margin assessment protocol that would affect data acquisition. 8. Subareolar location (cancer is directly and completely under the nipple/areolar complex) of breast abnormality. 9. Patients for whom English is not their native language
References
Publications (0)
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