Clinical Evidence

Published Papers and Studies

Reoperation Realities in Breast Cancer Care: An Analysis of the Impact on Patients and Healthcare Systems

This paper comprehensively analyzes current reoperation rates for breast-conserving surgery patients and their associated implications, underscoring the need for new strategies and technologies to address this problem.

Contemporary Analysis of Reexcision and Conversion to Mastectomy Rates and Associated Healthcare Costs for Women Undergoing Breast-Conserving Surgery

Youngran Kim, PhD; Cecilia Ganduglila-Cazaban, MD, DrPH; Nina Tamirisa, MD; Anthony Lucci, MD; Trudy Millard Krause, DrPH; Annals of Surgical Oncology, Feb. 06, 2024

This study was designed to provide a comprehensive and up-to-date understanding of population-level reoperation rates and healthcare costs associated with reoperation for patients who underwent breast-conserving surgery (BCS). The rates of reoperation after BCS have remained high and have contributed to increased healthcare costs.

The Fusion of Wide Field Optical Coherence Tomography and AI: Advancing Breast Cancer Surgical Margin Visualization

Yanir Levy, David Rempel, Mark Nguyen, Ali Yassine, Maggie Sanati-Burns, Payal Salgia, Bryant Lim, Sarah L. Butler, Andrew Berkeley, Ersin Bayram; Life-Optical Imaging and Fluorescence Imaging in Breast Cancer Diagnosis and Surgery. Dec. 14, 2023

This study explores the integration of Wide Field Optical Coherence Tomography (WF-OCT) with an AI-driven clinical decision support system, with the goal of enhancing productivity and decision making in breast cancer margin assessment. The results suggest the investigational deep learning model accurately identified 96.8% of pathology positive margins in WF-OCT images with high sensitivity and specificity.

Preoperative Imaging and Underestimation of Breast Tumor Size: Clinical Implications and Strategies

Accurate assessment of tumor size is crucial for effective surgical planning in cancer patients. Specific to breast cancer, however, preoperative imaging with mammography and ultrasound often underestimates the actual tumor size. This paper examines the drivers of underestimation, discusses clinical implications, and reviews methods to minimize the negative impact of underestimation on surgical outcomes.

Wide-field optical coherence tomography for microstructural analysis of key tissue types: a proof-of-concept evaluation

Beryl Rabindran, Adriana D. Corben; Pathology and Oncology Research, Jul. 14, 2023

Various tissues samples were obtained from a single autopsy and were imaged with WF-OCT then processed for permanent histology. The WF-OCT images captured in this study displayed the key features of the most common human tissue types encountered in surgical oncology with utility comparable to histology, confirming the utility of an FDA-cleared imaging platform. With further study, WF-OCT may have the potential to bridge the gap between the immediate information needs of the operating room and the longer timeline inherent to histology workflow.

Use of adjunct wide-field optical coherence tomography to visualize margins during breast conserving surgery for ductal carcinoma in situ: a case series

Amelia Tower, DO, FACOS; Mar. 21, 2023

Three women with biopsy confirmed DCIS and/or IDC undergoing breast-conserving surgery had their lumpectomy tissue imaged using intraoperative specimen radiography followed by WF-OCT. The surgeon used WF-OCT imaging in the OR to evaluate tissue microstructures and identify regions of interest that were not detected with intraoperative specimen radiography, allowing the surgeon to make real-time clinical decisions to excise additional tissue during the primary surgery. Pathology confirmed that all final margins were negative for residual disease. The removal of the additional tissue saved these 3 patients from the need for a second surgery.

Intraoperative Use of Wide-Field Optical Coherence Tomography to Evaluate Tissue Microstructure in the Oral Cavity and Oropharynx

Arvind K. Badhey, Julia S. Schwarz, Benjamin M. Laitman, Brandon M. Veremis, William H. Westra, Mike Yao, Marita S. Teng, Eric M. Genden, Brett A. Miles; JAMA Otolaryngology-Head & Neck Surgery, Dec. 1, 2022

This study evaluated the feasibility of using WF-OCT for visualizing microstructures at the margins of excised oral cavity and oropharyngeal tissue. The findings suggest that WF-OCT may be a promising imaging modality for intraoperative analysis in head and neck surgery, especially at deep margins, without impacting specimen integrity or surgical and pathology workflows.

Potential Utility of Adjunct Imaging with Wide-Field Optical Coherence Tomography for Gross and Microscopic Evaluation of Breast Specimens in Real-Time in the Operating Suite

Beth B. DuPree, Michael J. Papez, Elaina Pirruccello, Audrey Hassenflug; Indian Journal of Surgery, Nov. 26, 2021; Association of Surgeons of India 2021

This paper reports on the intraoperative use of Optical Coherence Tomography (OCT) in 3 patients with DCIS. In all 3 cases, additional lesions identified by OCT during surgery were also noted in histopathology reports 3 to 5 days post-surgery, suggesting that intraoperative use of OCT is a valuable tool for margin determination in real-time.

Evaluation of surgically excised breast tissue microstructure using wide-field Optical Coherence Tomography

Hank Schmidt, Courtney Connolly, Shabnam Jaffer, Twisha Oza, Christina R Weltz, Elisa R Port, Adriana Corben; The Breast Journal, Oct. 14, 2019

In this pilot study, evaluation of wide-field Optical Coherence Tomography demonstrated concordance with histology at tissue margins, supporting its potential for use as a real-time adjunct intraoperative imaging tool for margin assessment in surgically excised breast tissue.

Optical Coherence Tomography: A Novel Imaging Method for Post-lumpectomy Breast Margin Assessment —A Multi-reader Study

Richard Ha, MD; Lauren C. Friedlander, MD; Hanina Hibshoosh, MD; Christine Hendon, PhD; Sheldon Feldman, MD; Soojin Ahn, MD; Hank Schmidt, MD, PhD; Margaret K. Akens, PhD; MaryAnn Fitzmaurice, MD, PhD; Brian C. Wilson, PhD; Victoria L. Mango, MD; Academic Radiology, Nov. 22, 2017

Study results display the potential for Optical Coherence Tomography (OTC) as a real-time intraoperative tool for post-lumpectomy specimen margin assessment. This study revealed a relatively short training time and showed that readers from different medical specialties were able to distinguish suspicious from non-suspicious OCT imaging findings in ex vivo breast tissue confirmed by histology.

Feasibility Study of the Intra-operative Use of the OTIS™, Wide Field Optical Coherence Tomography (WF-OCT) in Surgically Excised Partial-mastectomy Breast Tissue

Lee Wilke, Adriana Corben, Elisa Port, Christina Weltz2, J. Jamie Alberty-Oller, Kaelin Grant, Mitch Piel, Hank Schmidt; ASBrS, Official Proceedings, Volume XXI, PAGE 187, 2020 Virtual Scientific Session

This abstract presents the effectiveness of lumpectomy specimen stabilization with a compression bag using Perimeter’s OTIS™ Optical Coherence Tomography (OTC) device. The use of compression to improve lumpectomy specimen imaging did not compromise specimen integrity for pathology and showed no statistical difference in re-excision rates. The OTIS™ OCT device seamlessly integrated into the intraoperative workflow for breast specimen imaging.

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