Optiscan Imaging is on a mission to prove its groundbreaking technology can provide surgeons with the exact extent of breast cancer margins at the time of operating through the real-time diagnosis of affected tissues.
The company has today revealed it has kicked off a study aimed at showing that its technology can help ensure all cancerous tissue is removed during surgery – eliminating the usual wait for biopsy results.
The study, in collaboration with breast surgeon Professor Bruce Mann and pathologist Dr Anand Murugasu, is underway at the Royal Melbourne, Frances Perry and Epworth Hospitals and is also supported by the Medical Device Partnering Program (MDPP).
The research cohort involves 50 patients with 59 distinct tumours. Intraoperative imaging, which takes place between operations or phases of surgery, has been performed during the initial part of the study for all fresh tumours, while 12 patients with 15 distinct tumours also underwent imaging after tissue fixation and processing in the pathology laboratory.
The company says initial real-time readings from its confocal laser endomicroscopic (CLE) imaging have shown an “excellent” correlation to more conventional – and more time-consuming – analysis.
The strong correlation and concordance of Optiscan technology to histo-pathology provides another strong indication for the utility of our unique digital CLE technology in breast surgery, as an adjunct in supporting clinical decision making in the operating theatre in the context of breast cancer margin analysis. Additionally, it paves the way for an ex vivo approach to assess fresh or fixed tissue with stand-alone in vitro diagnostic platforms which we are developing. We look forward to completing the analysis of the study … and advancing efforts to develop a new surgical device for this highly addressable market in parallel to a stand-alone in vitro pathology device. Optiscan Imaging chief executive office and managing director Dr Camile Farah
Dr Farah said breast-conserving surgery remained a complex challenge for health systems, with more than 175,000 lumpectomies performed annually in the United States alone and evidence revealing a re-excision rate of up to 35 per cent.
The company says good definition was possible in all 15 tumours that were cut out for laboratory fixation, with final diagnoses even including invasive lobular carcinoma – a type of breast cancer that begins in the milk-producing glands and then breaks out of the lobules where they began, before spreading to the lymph nodes and other areas of the body.
Additionally, Optiscan’s CLE probe was able to identify and differentiate healthy marginal tissue from positive cancer-involved margins in each case that was identified on gross sectioning and on final definitive histopathology. Assessment of fresh tissue produced excellent imaging quality and fixation did not negatively affect the quality of imaging compared to that of fresh tissue.
Optiscan’s proprietary laser-scanning confocal endomicroscopes capture digital histology from living tissue in real time, enabling clinicians to make immediate informed decisions.
The company has developed miniaturised microscopes into handheld, non-invasive imaging probes. Living tissue can be viewed with submicron resolution in 3D, enabling surgeons to visualise cellular architecture and subcellular details by simply touching the probe against the tissue of interest.
When breast cancer is surgically removed, such as during a biopsy, lumpectomy or mastectomy, a margin of normal tissue surrounding the tumour is also removed. Margins help to show whether all the tumour has been taken.
A “positive” or “involved” surgical margin, or the cut edge of a piece of removed tissue, means there are cancer cells in the margin, making it likely that cancerous cells remain in the body and that more surgery will be needed to remove the remaining cancer.
The object of the collaborative study is to determine if Optiscan’s imaging technologies are suitably definitive and can be applied during surgery or between phases of operations to help accelerate cancer diagnoses and ensure complete excisions the first time around. It is designed to provide benefits such as saving time, improving diagnoses and minimising recurrent surgeries.
Management says that by combining surgical precision, minimally-invasive techniques, personalised treatment strategies and real-time monitoring, its technology has the potential to reduce recurrence rates in lumpectomy patients and make a lasting positive impact on their lives.
It estimates CLE imaging could reduce gross operating time by 25 per cent, potentially saving hospitals millions of dollars in operating costs and reducing total recurrence costs in breast cancer treatment alone by up to US$6.4 billion (AU$9.95 billion).
Following the promising outcomes of the “ex vivo” (outside the body) imaging study, the company is now preparing for an intraoperative “in vivo” (inside the body) imaging assessment to assess the utility of the CLE probe in the hands of surgeons in real-time. The information will be critical for the development of a clinical user case and future US Food and Drug Administration submissions for oncological breast surgery.
There is no doubt that a successful outcome to the study has the potential to immeasurably reduce related costs, waiting and surgery time, stress and anxiety, and free up conventional pathology time for other evaluations where the technology may not be best suited.
Instant in-theatre answers for questions posed by surgeons may seem a medical pipedream – but it might not be too far away.
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