Clinical Evidence

Published Papers and Studies

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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