BACKGROUND: Margin status in breast lumpectomy procedures is a prognostic factor for local recurrence and the need to obtain clear margins is often a cause for repeated surgical procedures. A recently developed device for real-time intraoperative margin assessment (MarginProbe; Dune Medical Devices, Caesarea, Israel), was clinically tested. The work presented here looks at the diagnostic performance of the device. METHODS: The device was applied to freshly excised lumpectomy and mastectomy specimens at specific tissue measurement sites. These measurement sites were accurately marked, cut out, and sent for histopathologic analysis. Device readings (positive or negative) were compared with histology findings (namely malignant, containing any microscopically detected tumor, or nonmalignant) on a per measurement site basis. The sensitivity and specificity of the device was computed for the full dataset and for additional relevant subgroups. RESULTS: A total of 869 tissue measurement sites were obtained from 76 patients, 753 were analyzed, of which 165 were cancerous and 588 were nonmalignant. Device performance on relatively homogeneous sites was: sensitivity 1.00 (95% CI: 0.85-1), specificity 0.87 (95% CI: 0.83-0.90). Performance for the full dataset was: sensitivity 0.70 (95% CI: 0.63-0.77), specificity 0.70 (95% CI: 0.67-0.74). Device sensitivity was estimated to change from 56% to 97% as the cancer feature size increased from 0.7 mm to 6.6 mm. Detection rate of samples containing pure DCIS clusters was not different from rates of samples containing IDC. CONCLUSIONS: The device has high sensitivity and specificity in distinguishing between normal and cancer tissue even down to small cancer features. Copyright (c) 2010 Elsevier Inc. All rights reserved.
BACKGROUND: Margin status in breast lumpectomy procedures is a prognostic factor for local recurrence and the need to obtain clear margins is often a cause for repeated surgical procedures. A recently developed device for real-time intraoperative margin assessment (MarginProbe; Dune Medical Devices, Caesarea, Israel), was clinically tested. The work presented here looks at the diagnostic performance of the device. METHODS: The device was applied to freshly excised lumpectomy and mastectomy specimens at specific tissue measurement sites. These measurement sites were accurately marked, cut out, and sent for histopathologic analysis. Device readings (positive or negative) were compared with histology findings (namely malignant, containing any microscopically detected tumor, or nonmalignant) on a per measurement site basis. The sensitivity and specificity of the device was computed for the full dataset and for additional relevant subgroups. RESULTS: A total of 869 tissue measurement sites were obtained from 76 patients, 753 were analyzed, of which 165 were cancerous and 588 were nonmalignant. Device performance on relatively homogeneous sites was: sensitivity 1.00 (95% CI: 0.85-1), specificity 0.87 (95% CI: 0.83-0.90). Performance for the full dataset was: sensitivity 0.70 (95% CI: 0.63-0.77), specificity 0.70 (95% CI: 0.67-0.74). Device sensitivity was estimated to change from 56% to 97% as the cancer feature size increased from 0.7 mm to 6.6 mm. Detection rate of samples containing pure DCIS clusters was not different from rates of samples containing IDC. CONCLUSIONS: The device has high sensitivity and specificity in distinguishing between normal and cancer tissue even down to small cancer features. Copyright (c) 2010 Elsevier Inc. All rights reserved.
Authors: Stephanie Kennedy; Joseph Geradts; Torre Bydlon; J Quincy Brown; Jennifer Gallagher; Marlee Junker; William Barry; Nimmi Ramanujam; Lee Wilke Journal: Breast Cancer Res Date: 2010-11-05 Impact factor: 6.466
Authors: Kathryn Ottolino-Perry; Anam Shahid; Stephanie DeLuca; Viktor Son; Mayleen Sukhram; Fannong Meng; Zhihui Amy Liu; Sara Rapic; Nayana Thalanki Anantha; Shirley C Wang; Emilie Chamma; Christopher Gibson; Philip J Medeiros; Safa Majeed; Ashley Chu; Olivia Wignall; Alessandra Pizzolato; Cheryl F Rosen; Liis Lindvere Teene; Danielle Starr-Dunham; Iris Kulbatski; Tony Panzarella; Susan J Done; Alexandra M Easson; Wey L Leong; Ralph S DaCosta Journal: Breast Cancer Res Date: 2021-07-12 Impact factor: 6.466
Authors: Giang H T Au; Wan Y Shih; Wei-Heng Shih; Linette Mejias; Vanlila K Swami; Kimberly Wasko; Ari D Brooks Journal: Int J Surg Oncol Date: 2012-12-24