One of the activities planned within the scope of the MammoScreen clinical investigation is the interim analysis, a data checkpoint and an opportunity to evaluate how well the AI algorithm is performing before the end of the study. The interim analysis was planned for the moment when the clinical trial reached 3,000 women, and we are pleased to have achieved this pivotal milestone in the beginning of 2025, as estimated in the recruitment projections.
With the interim analysis, our researchers want to check if the MammoWave technology combined with AI is correctly identifying signs of breast cancer. For that, they look at key performance indicators, such as sensitivity and specificity, to ascertain if the AI routine is detecting cancer when it’s there and if false alarms are being reduced.
One of the key drivers for the interim analysis is to ensure full compliance with our rigorous patient safety protocols and ethical standards. The team also needs to be able to identify areas for improvement before the end of the study, so that corrective action can be implemented. For instance, if the analysis shows that certain patterns are being misinterpreted, our experts can refine the AI algorithm to improve accuracy. On another hand, if the preliminary data shows that the technology is underperforming or leading to too many false results, adjustments could be made to improve the monitored parameters.
Overall, the interim analysis is a powerful guide for future development and the results will help researchers decide what needs fine-tuning in the AI data analysis. The interim analysis is a critical milestone. It helps to validate and refine the AI model and ensures that the project stays on track. The clinical team will resume the recruitment of participants (aiming for up to 10,000 women) once the interim analysis is completed, using what they learned to update and improve the AI model before the final analysis. This step-by-step approach ensures that the technology is as accurate and safe as possible before being considered for wider use.
