The MammoScreen clinical trial is well under way and we are pleased to report significant progress in the recruitment of volunteers. Following the ethical and regulatory body approval in the five countries where the trial is being conducted – Italy, Spain, Portugal, Poland and Switzerland – recruitment is progressing at a steady pace in a total of nine clinical sites. We are excited to report that, by November 2024, the study had enrolled 2,283 of the aimed 10,000 participants.
As recruitment picks up pace, the Consortium expects to achieve 3,000 volunteers by early 2025. This is an important checkpoint for the project, because it allows a preliminary evaluation of the quality of the data and of the efficacy of the AI analysis protocol, so that adjustments can be made before the end of the recruitment process. The data collected up to this point will also be used to assess if the device’s performance has met or exceeded expectations in terms of diagnostic accuracy and ease of use. The main goal of the clinical study is to determine if MammoWave combined with AI can accurately detect breast cancer with over 75% sensitivity (ability to find cancer when it’s there) and over 90% specificity (avoiding false alarms). Analysis of the preliminary data will also highlight the areas of success that need to be maintained, or even enhanced, in order to ensure the completion of the trial. This success barometer, paired with the feedback response from the participant clinical centres, will inform the research team and other stakeholders on the best course of action for the future.
The Clinical Research Organization (CRO) that supports UBT in the management of the clinical trial regularly conducts assessments to ensure consistency in results. These evaluations have helped to swiftly address any procedural issues, keeping the trial running smoothly and effectively. A key aspect of this success has been the dedicated electronic case report form (e-CRF), a tracking tool that streamlines data collection and allows real-time monitoring of the results.
Looking ahead, the Consortium remains focused on upholding high standards through the trial’s final stages, anticipating that the continued levels of engagement and data quality will support a smooth path toward regulatory approval. So far, the clinical trial serves as an excellent case study in effective trial design, participant recruitment, and project management, setting a high bar for futurestudies involving medical devices.
