Prospective Validation of Ex Vivo Fusion Confocal Microscopy for Intraoperative Margin Assessment in Breast-Conserving Cancer Surgery
Munich, July 3 2026 – In this publication, the authors report a prospective validation study aiming to consolidate the clinical applicability of VivaScope® 2500 in breast-conserving surgery.
In this publication, the authors report a prospective validation study aiming to consolidate the clinical applicability of VivaScope® 2500 in breast-conserving surgery.
Accurate intraoperative margin assessment is essential for ensuring complete tumor excision in breast-conserving surgery. Given the clinical importance of achieving clear margins, intraoperative margin assessment is considered a fundamental strategy to minimize the need for reoperation. Frozen section analysis is the gold standard microscopic method for rapid intraoperative margin evaluation. However, its reliability is compromised in adipose-rich or fragmented breast tissue, where sectioning artefacts and sampling variability may distort the architecture and hinder both intraoperative and subsequent histopathological evaluations. These factors, coupled with interpretative complexity and time constraints, may lead to false-negative results, ultimately limiting the diagnostic reliability of this method in routine clinical settings. These challenges have resulted in reoperation rates exceeding 20% in international breast-conserving surgery series, highlighting the clinical need for improved intraoperative margin assessment strategies. In this context, real-time digital pathology tools have attracted growing interest as potential solutions.
In this study, the innovative VivaScope® 2500 technology allowed rapid examination of 146 breast tissue samples obtained from 98 patients. Interobserver agreement was almost perfect for neoplasia detection (97.3%) and tumor type classification (93.8%). VivaScope® 2500 achieved 93.7% sensitivity and specificity, with 94.0% accuracy for tumor detection; 95.8% accuracy for tumor type classification; and 95.1% accuracy for invasive subtype identification. For margin assessment, VivaScope® 2500 achieved 80% sensitivity, 100% specificity, and 99.3% accuracy. Beyond the positive or negative margin status, the capacity of VivaScope 2500 to assess the distance between tumor cells and the resection edge represents an additional diagnostic advantage. In this study, the evaluation of margin distance (<2 mm vs. ≥2 mm) yielded a sensitivity of 75% and specificity of 100%. These results demonstrate that VivaScope can not only detect residual tumors but can also estimate their spatial proximity to the margin, providing valuable information for intraoperative decision-making. Given that the local recurrence risk increases as the tumor distance to the margin decreases, the ability to identify cases within this critical threshold (<2 mm) offers significant prognostic value. This quantitative capability enhances the clinical utility of VivaScope, enabling surgeons to perform targeted re-excisions during the same procedure, thereby reducing the likelihood of secondary surgeries.
The novel intraoperative margin assessment pathway offers the following advantages:
- High sensitivity, specificity, and overall diagnostic accuracy for both tumor detection and margin evaluation
- Real-time intraoperative margin evaluation in less than five minutes
- Estimation of residual tumors spatial proximity to the margin within critical threshold (<2 mm)
- Enable surgeons to perform targeted re-excisions during the same procedure
The VivaScope® 2500 enables rapid, high-resolution imaging of fresh breast tissue, facilitating real-time intraoperative margin evaluation with excellent diagnostic concordance and workflow efficiency. Its integration into surgical practice could reduce re-excisions, enhance oncological safety, and improve patient outcomes in breast-conserving surgeries.