ASX-listed medical technology company Optiscan Imaging has commenced recruitment for a groundbreaking clinical trial at the Royal Melbourne Hospital, aiming to enhance surgical precision and reduce repeat procedures in breast cancer treatment. The trial will involve up to 50 patients and evaluate the company's advanced InVue and InForm imaging systems, setting the stage for U.S. FDA submissions.
The study marks the company’s first in-human breast cancer trial and will assess the clinical workflow and real-time imaging performance of its devices in a surgical setting. These platforms are designed to address a persistent challenge in breast cancer surgery: ensuring clear surgical margins—removing the tumour entirely with a surrounding border of healthy tissue to reduce recurrence.
During lumpectomy procedures, surgeons will use the InVue precision surgery device to capture live, cellular-level images of the surgical site immediately after tumour removal. This intraoperative feedback allows for real-time assessment of tumour margins, potentially reducing the need for follow-up surgeries and improving long-term outcomes.
“We believe our innovative real-time microscopic imaging platform represents a genuine breakthrough in surgical cancer management,” said Dr. Camile Farah, CEO and Managing Director of Optiscan Imaging. “By providing surgeons with high-resolution, live cellular imaging at the bedside, InVue enables confident, informed decisions about tumour clearance before the patient even leaves the operating room.”
Following surgical resection, the excised tissue will be examined with InForm, Optiscan’s digital pathology imaging system, which uses topical dyes and offers rapid, high-resolution ex vivo tissue analysis. The additional data generated by InForm will be integrated into the company’s broader imaging and pathology workflow and support the regulatory approval process.
Although both InVue and InForm were designed to operate independently, they are being used together in the study to optimize data capture, minimize the need for future trials, and expedite FDA submissions. InForm will also be used on tissue samples collected chairside and in pathology labs to validate consistency across different use cases.
Professor Bruce Mann, Director of Breast Cancer Services at Royal Melbourne and Royal Women’s Hospitals, emphasized the impact of the trial: “Inadequate margins often lead to additional surgeries, increased patient anxiety, and delayed treatments. Real-time imaging tools that support surgical accuracy can significantly improve patient outcomes while reducing the burden on healthcare systems.”
Optiscan highlights that its technologies could bridge the critical gap between intraoperative imaging and diagnostic pathology, enabling a digital, integrated surgical oncology workflow. This innovation has the potential to eventually replace the frozen section technique, currently a standard pathology practice.
As the most common cancer among women globally, breast cancer affects millions each year. With rising survival rates attributed to advances in treatment, innovations like Optiscan’s aim to further improve outcomes by minimizing tissue removal, enhancing accuracy, and ultimately reducing healthcare costs. The company’s integrated imaging approach could redefine the future of breast cancer surgery.