Melbourne breast cancer trial to test Optiscan imaging device

ASX-listed medical technology company Optiscan Imaging has started recruiting up to 50 patients for a Royal Melbourne Hospital clinical trial of its innovative precision surgery and digital pathology imaging devices, aiming to improve a common breast cancer surgery.

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.

A 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.

Optiscan says bringing its technology into operating theatres could be transformative as it has the potential to bridge the gap between diagnostic imaging and surgical decision-making, which could significantly reduce the reliance on post-operative pathology.

It says the process could improve a surgeon’s accuracy in determining tumour margins during a patient’s initial procedure, potentially minimising the need for follow-up surgeries, while lowering healthcare costs and improving overall patient care.

Optiscan Imaging chief executive officer and managing director Dr Camile Farah said: “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. In the process, InVue will provide surgeons with digital tools to make confident, informed decisions about tumour clearance before patients leave the operating theatre.”

Farah said an ability to evaluate tumour margins with cellular-level precision during surgery could revolutionise breast cancer treatment, as real-time imaging would open the way for complete tumour removal, while preserving healthy tissue.

Breast cancer is the world’s most common cancer among women, with millions of new cases diagnosed annually. Survival rates have increased dramatically over the past few decades, thanks to innovations in drug and surgical treatments.

Lumpectomy is a modern treatment that aims to remove a tumour while conserving as much of the healthy breast tissue around it as possible.

As Royal Melbourne and Royal Women’s Hospitals director of breast cancer services Professor Bruce Mann explained, inadequate margins can often lead to additional surgeries, increase the physical and emotional strain on patients, delay subsequent treatments and raise healthcare costs.

“This highlights the critical need for innovative solutions that enable surgeons to assess tumour margins accurately and in real-time during the initial surgical procedure, improving outcomes for patients and reducing the burden on healthcare systems,” he said.

Optiscan says achieving a seamless surgical oncology-pathology workflow from both its devices would provide further evidence supporting a digital transition for common surgical procedures. As a bonus, it could also build more evidence that its innovative InForm device could replace the standard frozen section technique currently used by pathologists.

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