Can Optiscan’s Real-Time Imaging Cut Repeat Breast Cancer Surgeries?
Optiscan Imaging Ltd has commenced a landmark clinical study at Royal Melbourne Hospital, testing its cutting-edge InVue® and InForm™ devices to improve breast cancer surgery precision. The study aims to generate critical data for US FDA approval and could redefine surgical oncology workflows.
- First in-human breast cancer study initiated using InVue® and InForm™ devices
- Recruitment of 50 patients undergoing breast-conserving surgery underway at Royal Melbourne Hospital
- Real-time in vivo imaging aims to improve surgical margin assessment during lumpectomy
- Ex vivo digital pathology imaging complements live surgery data for comprehensive analysis
- Data will support US FDA regulatory submissions and advance AI/ML imaging algorithms
A New Frontier in Breast Cancer Surgery
Optiscan Imaging Ltd (ASX, OIL) has taken a significant step forward in breast cancer treatment by initiating its first in-human clinical study at the Royal Melbourne Hospital. The study will evaluate the performance of Optiscan’s innovative InVue® precision surgery imaging device alongside its InForm™ digital pathology platform. These devices promise to transform how surgeons assess tumour margins during breast-conserving surgeries, potentially reducing the need for repeat operations.
Breast cancer remains the most common cancer among women worldwide, with lumpectomy procedures aiming to remove tumours while preserving healthy tissue. However, accurately determining if all cancerous cells have been excised remains a challenge, often resulting in additional surgeries. Optiscan’s technology seeks to address this by providing surgeons with real-time, cellular-level imaging during surgery, enabling immediate assessment of tumour clearance.
Innovative Imaging Devices in Action
The study will recruit 50 patients undergoing breast-conserving surgery, using the InVue® device to capture live, in vivo images of the surgical cavity after tumour removal. This approach employs intravenous fluorescein sodium as a contrast agent to differentiate cancerous tissue from healthy cells. Complementing this, the InForm™ device will provide high-resolution ex vivo imaging of excised tissue samples, enhancing the pathology workflow and offering additional data to confirm surgical margins.
By integrating these two devices, Optiscan aims to create a seamless digital workflow bridging surgery and pathology. This holistic approach not only supports more accurate intraoperative decision-making but also accelerates data collection for regulatory submissions to the US Food and Drug Administration (FDA). Furthermore, the imaging data will feed into the development of artificial intelligence and machine learning algorithms, potentially enhancing diagnostic precision in the future.
Clinical Leadership and Strategic Vision
The study is led by Professor Bruce Mann, Director of Breast Cancer Services at Royal Melbourne and Royal Women’s Hospitals, alongside Dr. Laura Chin-Lenn and Dr. Anand Murugasu. Their involvement underscores the clinical significance and potential impact of this research. Optiscan’s CEO, Dr. Camile Farah, highlighted the transformative potential of the technology, emphasizing its ability to bring live cellular imaging directly into the operating theatre and set new standards for precision in oncology.
Professor Mann noted the critical need for innovative solutions to reduce inadequate surgical margins, which often lead to additional surgeries and increased patient burden. The study’s success could not only improve patient outcomes but also alleviate healthcare system pressures by minimizing repeat procedures.
Looking Ahead
With ethical clearance secured in mid-2024 and recruitment now underway, Optiscan is poised to gather pivotal clinical evidence supporting its devices’ efficacy. The outcomes of this study will be closely watched by investors, clinicians, and regulators alike, as they could herald a new era in breast cancer surgery and digital pathology.
Bottom Line?
Optiscan’s clinical study could redefine breast cancer surgery precision and accelerate its path to FDA approval.
Questions in the middle?
- How quickly will patient recruitment progress and when might interim results be available?
- What are the anticipated timelines for FDA regulatory submissions and approvals based on this study?
- How will the integration of AI/ML algorithms enhance the diagnostic capabilities of Optiscan’s imaging platforms?
