Melbourne breast cancer trial to test Optiscan imaging device
The groundbreaking clinical study will utilise Optiscan's InVue microscopic precision surgery device, as well as its InForm digital pathology imaging system, to create a new, improved treatment regimen for breast cancer patients.
The company will investigate the clinical workflow and real-time imaging capabilities of the two platforms in its first in-human breast cancer study. Optiscan will use data from the trial in its submissions for United States Food and Drug Administration (FDA) registration for the devices.
Surgeons will use the InVue device during surgery to capture live imaging data from a woman's breast tissue after removing a tumour. It will provide the surgical team with immediate feedback on tumour clearance, ensuring there is a margin of healthy breast tissue around the site where the tumour was removed.
Achieving a clear surgical margin, where no cancerous cells are left at the edges of the removed tissue, is critical to a patient's long-term health outcome but poses a significant surgical challenge.
'We believe our innovative real-time microscopic imaging platform represents a genuine breakthrough in surgical cancer management by bringing live cellular imaging to the bedside.'
Optiscan Imaging chief executive officer and managing director Dr Camile Farah
Using topical dyes, the removed tissue will then be examined with the InForm device to back up the InVue imaging. The additional InForm pathology data will be fed back into the company's imaging and pathology workflows ahead of its FDA application.
The study will also incorporate InForm imaging of tissue samples taken chairside or from pathology laboratories to match its other ex vivo patient data. InForm can assess new tissue samples quickly and accurately with high resolution and magnification.
While each device was designed to operate independently, Optiscan says it purposefully included both in the trial to maximise data collection, minimise the need to recruit patients into further trials and accelerate its regulatory submissions.
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