Perimeter has conducted a randomized, controlled, multi-site, pivotal clinical trial to test its B-Series OCT8 with ImgAssist AI against the current standard of care and assess the impact on re-operation rates for patients undergoing breast-conserving surgery.
In November 2024, Perimeter released positive topline results for its pivotal trial, showing that the Perimeter B-Series OCT with ImgAssist AI demonstrated super-superiority compared to the standard-of-care.
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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.
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.
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.
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.
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.
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.
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.
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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