During the second reporting period, the following technical and scientific activities were implemented.
I) Advisory support to scientific and methodological activities
The Scientific and Data & Ethics Advisory Boards continued to support core project activities, focusing on the interpretation of interim clinical results, methodological soundness of algorithm updates, and ethical and data-related aspects. Their input contributed to ensuring scientific rigour and appropriate framing of feasibility evidence.
II) Execution of the multicentric clinical investigation
RP2 focused on the execution of the multicentric prospective clinical investigation within organised screening programmes, including patient recruitment, harmonised data acquisition and quality control across sites. Interim analyses enabled the assessment of operational feasibility and preliminary performance benchmarking under real-world, low-prevalence screening conditions.
III) Algorithm development and methodological research
AI-based analysis of microwave imaging data was further developed following a predefined, protocol-driven approach informed by interim analyses. Methodological work addressed class imbalance and early-stage lesion detection and demonstrated that microwave signals encode information related to breast tissue characteristics, including breast density, leading to peer-reviewed publications.
IV) Operationalisation of the Health Technology Assessment framework
Health Technology Assessment activities progressed to model operationalisation, with the development and calibration of an interim framework using real-world clinical data. This provided a structured basis to explore economic, organisational and quality-of-life aspects while explicitly accounting for uncertainty and evidence gaps.
