Periodic Reporting for period 2 - MammoScreen (Innovative and safe microwave-based imaging technology to make breast cancer screening more accurate, inclusive and female-friendly)
Berichtszeitraum: 2024-06-01 bis 2025-11-30
Breast cancer is the most common cancer among women, affecting around one in eleven by the age of 74. While population-based mammography screening reduces mortality, it has recognised limitations, including reduced performance in women with dense breast tissue and barriers to participation. MammoScreen addresses these challenges by investigating an innovative breast imaging technology based on microwave signals. The project generates clinical, technical and system-level evidence to assess the potential role of the microwave-based device MammoWave in screening-related contexts. MammoWave is being evaluated in a large multicentric clinical investigation involving women enrolled in national and regional screening programmes, using an examination that requires no specialised infrastructure. Data are analysed using machine-learning–supported software, and an integrated Health Technology Assessment component explores economic, organisational and quality-of-life aspects. Patient and public involvement is embedded throughout the project, in line with the EU Cancer Mission objectives on early detection, inclusivity and reduction of inequalities.
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.
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.
MammoScreen has advanced the evaluation of innovative breast imaging technologies in screening-related contexts by assessing the MammoWave device within a large multicentric prospective clinical investigation embedded in organised screening programmes. The project generated initial feasibility and performance evidence under real-world screening conditions, providing transparent benchmarks that highlight both the potential of microwave imaging and its current limitations, particularly those linked to low disease prevalence and early-stage lesion detection. In parallel, AI-based analysis was advanced within a controlled research framework, including a protocol-driven algorithm update and methodological work showing that microwave signals encode information related to breast tissue characteristics, leading to a peer-reviewed publication on breast density classification. Beyond clinical aspects, MammoScreen developed an interim health technology assessment framework and integrated patient and public perspectives on acceptability and communication. Overall, the project contributes to more responsible and informed assessment of emerging screening technologies, aligned with the objectives of the EU Cancer Mission, while indicating the need for further research focused on well-defined populations and more mature evidence.