Optiscan Imaging (ASX: OIL) has received the nod of approval from the Royal Melbourne Hospital to start taking real-time in-human images during surgery for breast cancer patients using its cutting-edge, microscopic “InVue” technology.
The vital “ethical clearance” for the recently-revealed device paves the way for an in-vivo study aimed at better diagnosing cancer cells in a trial that is expected to enrol 50 patients. In-vivo refers to a test or procedure in or on a living organism, such as a person, lab animal or a plant, and the company says it will provide a better assessment of cancer margins during surgery.
The study is expected to assess Optiscan’s high-tech InVue surgical platform on patients presenting for lumpectomy procedures at a prestigious trio of hospitals that includes the Royal Melbourne, the Epworth in Richmond and Francis Perry House in Parkville.
A lumpectomy procedure removes only the cancerous tumour and a margin of the small rim of normal tissue sitting around it, with a view to leaving as much breast skin and tissue as possible in place. The InVue device will collect in-vivo imaging data of the surgical cavity during surgery and after tumour removal to determine the most effective clearance of the tumour while leaving a sufficient margin of tissue in place.
The study will use an intravenous (IV) fluorescein sodium as the contrast agent and will then assess the uptake of the contrast dye in both normal and cancerous breast tissues.
Management notes that recent analyses of breast cancer lumps imaged ex-vivo, meaning outside of the body, shows strong similarities between Optiscan’s imaging and histopathology, which is considered to be the gold-standard in the microscopic examination of tissues. The imaging provides similar features to that observed by pathologists from histopathology testing under microscopic viewing.
The non-interventional study design will allow the research team the opportunity to gather imaging data without the procedure interfering with standard of care. Once this stage is completed, we anticipate progressing to further recruitment with an interventional protocol. In this phase, collected images will guide surgeons in decision-making, determining tumour clearance or the need for additional tissue related to microscopic spread, before patient discharge.
Optiscan Imaging Managing Director and CEO Dr Camile Farah
The company’s InVue platform is a microscopic medical imaging device that delivers what could be termed an “optical biopsy”. It provides biopsy-free, slide-free imaging of live single cells in real time during surgery.
The technology could provide tremendous benefits, such as surgeons having immediate pathology insights within the operating theatre, enabling on-the-spot decision-making, adjusting planned treatment and allowing for more precise surgical outcomes. A more accurate diagnosis is also likely to reduce the need for follow-up procedures or surgery.
InVue’s microscopic imaging can be used for clearly-defined targeting of cancer screening and assessment of a surgical margin. It is a non-invasive process and designed for ease of use in clinical settings.
Unlimited sampling is also possible across diseased tissue.
Management is expecting the initial trial stage to be successful and already has plans to progress to an intervention phase where the images will guide surgeons in their decision-making process prior to surgery.
Optiscan has formed a solid relationship with respected and well-credentialled medical institutions and it will be interesting to see how far that can take the company’s high-tech imaging equipment.
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