A new clinical research study, conducted in partnership between CytoVeris Inc. and AdventHealth in Central Florida, will investigate the precision of using an AI-powered imaging device during surgery to improve prostate cancer margin assessment. Called MarginASSURE, this device is expected to provide more precise surgical decision-making in real time as well as improve patient outcomes.
The study will focus on CytoVeris’ multispectral imaging capability for the intraoperative assessment of cancer margin during robotically assisted radical prostatectomy (RARP) surgery, and will involve only U.S.-based surgeries at AdventHeath Celebration led by Vipul Patel, M.D., founder and medical director of the Global Robotics Institute at AdventHealth Celebration, and his team.
Patel is world-renowned for his contribution to the field of robotic-assisted surgery and is one of the most experienced robotic surgeons in the world, having personally performed over 16,000 robotic prostatectomies.
Why it matters:
According to the American Cancer Society, other than skin cancer, prostate cancer is the most common cancer in American men and nearly 35,000 are estimated to die from this disease each year.
Of the 288,000 men per year in the U.S. who are diagnosed with prostate cancer, approximately 90,000 of those patients undergo RARP surgery . Post-surgical positive margin rates are generally about 20% and can lead to complications and poorer patient outcomes .
How the device will be used in the study:
During the course of the multi-year study, Patel will collaborate with CytoVeris in adapting and developing its imaging platform for prostate cancer margin assessment.
“In the operating room, every move is critical. Robotic devices are changing the way we (surgeons) operate by providing more precision, therefore better patient outcomes,” Patel said. “This study will attempt to demonstrate the capability of MarginASSURE and its ability to detect cancer in near-real time in a label-free manner through the development of advanced tissue characterization technologies that can identify cancer tissue, assess margins, and identify critical tissue structures.”
The CytoVeris system is based on a proprietary Multi-Spectral Tissue Auto-Fluorescence (AF) Imaging technology which analyzes the “optical fingerprint” of tissue due to its intrinsic biomolecular and morphological characteristics, without the use of dyes or imaging agents.
MarginASSURE, the prostate imaging device, is designed to provide the rapid margin assessment of excised prostate specimens, and deliver the surgeon actionable data to help guide the surgical steps required to better optimize the patient outcomes, and optimize nerve sparing.
The project work will incorporate and correlate pre-operative MRI imaging of tumors with the MarginASSURE imaging of RARP specimens suspect of extraprostatic/extracapsular extension of cancer into the periprostatic soft tissues.
“CytoVeris was founded on the vision that by leveraging advanced optical imaging and artificial intelligence, surgeons will have the ability to visualize cancer when it matters most – in the operating room,” said Dr. Alan D. Kersey, Ph.D., president & CEO of CytoVeris. “This clinical research study aims to demonstrate and validate our technology in prostate cancer, opening doors to further optimize patient outcomes.”
- Underwood, W., III, Jackson, J., Wei, J.T., Dunn, R., Baker, E., DeMonner, S. and Wood, D.P. (2005), Racial treatment trends in localized/regional prostate carcinoma: 1992–1999. Cancer, 103: 538-545. https://doi.org/10.1002/cncr.20796
- Iczkowski KA, Lucia MS. Frequency of positive surgical margin at prostatectomy and its effect on patient outcome. Prostate Cancer. 2011;2011:673021. doi: 10.1155/2011/673021. Epub 2011 Jun 9. PMID: 22110996; PMCID: PMC3200270.
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