Intraoperative Margin Assessment

The below content has been supplied directly by innovators/industry and does not imply endorsement from iBRA-NET.

ClearSight surgical MRI

ClearCut Medical has developed an intra-operative MRI scanner for excised tissue, which gives the operating surgeon real-time information about the tissue microstructure in the margins of a surgically excised lump and additional extensions. The ClearSight specimen MRI can be manually wheeled into the OR and operates off a regular power socket without the need for any additional infrastructure. The system generates diffusion maps of the specimen surface layers, which require neither radiology nor pathology training from the surgeon - a simple color code indicates the presence of either malignant or beginning lesions in the margins. ClearSight has shown excellent accuracy (80%-90%, compared to final histopathology) in three international, clinical studies with together over 300 patients. According to the latest study performed in Frankfurt (Germany) by PD Dr. Thill, the technology can reduce re-excision rates by 80% in the current version, with even better numbers expected for the ClearSight XT to be launched in 2019. The ClearSight system is CE marked, FDA approval is expected for H2 2019.

References:

Papa et al:" An Intraoperative MRI System for Margin Assessment in Breast ConservingSurgery: Initial Results From a Novel Technique", Journal of Surgical Oncology, May 2016 Posters at ASBrS 2017 (Teal, C. et al.) and SABCS 2018 (Thill, M. et al.)

MasSpec Pen

MasSpec Pen is a breakthrough handheld device that can detect cancer margin upon contact with a tissue using water droplet. Currently, the histologic methods that are used in the clinic to evaluate the presence of cancer during surgery are very outdated, taking over 30 minutes to be completed, which exposes the patient to increased risks of infection and extended anaesthesia and can only be performed on tissue that has already been removed from the patient. The MasSpec Pen has the potential to revolutionise surgery by providing the surgeon with a device that enable accurate and rapid cancer detection before tissue is even removed. The pen-sized device extracts biological molecules from tissue upon contact with the tissue surface using water. This process is so gentle that it does not cause any visible harm to the tissue. The water containing the biomarker are then transferred to a sophisticated mass spectrometer, which characterised the profile of chemical biomarkers obtained. Then using machine learning algorithms and software tools, a predictive diagnosis is provided to the surgeon. This entire process happens in less than 10 seconds. The MasSpec Pen technology could be easily incorporated into the surgical workflow in that it is fully automated, triggered using a foot pedal, easy to use, disposable, and biocompatible. Right now, MasSpec Pen is still in research and development phase.

References:

Jialing Zhang, John Rector, John Q. Lin, Jonathan H. Young, Marta Sans, Nitesh Katta, Noah Giese, Wendong Yu, Chandandeep Nagi, James Suliburk, Jinsong Liu, Alena Bensussan, Rachel J. DeHoog, Kyana Y. Garza, Benjamin Ludolph, Anna G. Sorace, Anum Syed, Aydin Zahedivash, Thomas Milner, and Livia S. Eberlin*, Nondestructive Tissue Analysis for Ex Vivo and In Vivo Cancer Diagnosis using a Biocompatible Mass Spectrometry System, 2017, 9(406); eaan3968. PMID: 28878011

The MOZART Specimen Tomosynthesis System

The Mozart System uses tomosynthesis to give surgeons a three dimensional view of excised breast cancer specimens during lumpectomy procedures. This technology gives the surgeon a real time view of surgical margins, allowing for more accurate cavity shaves. Clinical studies show that use of the Mozart System enables a reduction in re-excision rates of 50% compared to traditional 2-D intraoperative radiographs (see references). Additionally the technology has a high specificity for identifying positive margins - 91% - which reduces false positives and enables the surgeon to practice maximum conservation of healthy tissue (see references). The Mozart System was introduced in 2016, is FDA/ CE approved and available worldwide from KUBTEC

References:

Natalia Partain MD, Carissia Calvo MD, Ali Mokdad MD, Andrea Colton MD, Katherine Pouns MD, Edward Clifford MD, Deborah Farr MD, James Huth MD, Rachel Wooldridge MD & A. Marilyn Leitch MD. Differences in Re-excision Rates for Breast-Conserving Surgery Using Intraoperative 2D Versus 3D Tomosynthesis Specimen Radiograph. Annals of Surgical Oncology volume 27, pages4767–4776(2020)
Ko Un Park, MD, Henry M. Kuerer, MD, PhD, Gaiane M. Rauch, MD, PhD, Jessica W. T. Leung, MD, Aysegul A. Sahin, MD, Wei Wei, MS, Yisheng Li, PhD, Dalliah M. Black, MD. Digital Breast Tomosynthesis for Intraoperative Margin Assessment during Breast-Conserving Surgery. Ann Surg Oncol (2019) 26: 1720-1728