Breast Cancer Awareness Month
October is the month to wear pink in support of all those affected by breast cancer. Celebrated globally as the Breast Cancer Awareness Month (BCAM), October 2024 was full of opportunities to promote awareness and fundraise for research on the causes, detection and treatment of a disease that is responsible for approximately one third of the cancers diagnosed in women in the EU. Acknowledging the challenge that beating cancer has become, the EU increasingly funds research and innovation in this theme. Breast cancer, in particular, is the focus of several innovative projects funded by Horizon Europe and Horizon 2020: the REBECCA project, investigating the chronic conditions and comorbidities associated with breast cancer and its treatment, using real-world data (RWD); RadioVal, developing radiomics tools driven by AI to personalize breast cancer treatment; ONCOVALUE, collecting high-quality RWD to improve breast and lung cancer care; the RESCUER project, predicting patient responses to drug combinations to identify optimal treatment regimens, improving outcomes and enhancing patients’ quality of life; and MammoScreen, of course. At their core, all these initiatives have a patient-centric and personalized approach that will bring important contributions to the implementation of the Europe Beating Cancer Plan. The European Commission is committed to support member states to increase the uptake of cancer screening programmes. BCAM campaigns can help tackle marked differences in screening participation among countries and population groups. Social initiatives have an important role to play as well, if 90% of the eligible target population across the EU is to be screened by 2025. For example, Europa Donna – a coalition of non-profit organizations that advocate for European women on breast cancer based in Italy – launched the Breast Health Day campaign in October, to help women improve their breast health. October was also the month chosen by the Breast Cancer in Young Women Foundation (BCYW) to organize the 1st International Conference on Young Women’s Breast Cancer and Health, in recognition that breast cancer in women under 40 is increasing worldwide. In Portugal, the 2nd edition of the information campaign “Mine is Different from Yours” (in Portuguese) explained in non-expert language that there are various subtypes of breast cancer, each with different diagnoses, prognoses, and approaches. Patient associations, such as EVITA, and the Portuguese League Against Cancer, together with the Portuguese Society of Senology, the Portuguese Society of Oncology, AstraZeneca, and Daiichi Sankyo, partnered in this initiative. In the region of Castilla-la Mancha, Spain, Dr. Cristina Romero Castellano, Head of the Radiodiagnosis Department at the University Hospital of Toledo and an international leader in the field of breast cancer diagnosis, spoke to the media about the latest scientific advances regarding breast cancer and the innovative projects rolled out in the region, including MammoScreen. She is a natural communicator of science to the general public and not many people know that her enthusiasm for the MammoWave technology paved the way for the pilot study that was the starting point for MammoScreen. Those fluent in Spanish can follow her in a TV interview and podcast conversation where she explains why a safe, inclusive and comfortable technology for the early detection of breast cancer is so important, and how AI, under adequate ethical and regulatory frames, is going to become an ally in the fight against the disease.
The 5th in-person Consortium Meeting of the MammoScreen Project
The San Francesco Convent, residence of the IMT School for Advanced Studies IMT Lucca, has been magnificently restored to offer state-of-the-art university campus buildings within Lucca’s historic Renaissance walls. Once a place of Franciscan theological and philosophical studies, the Convent has stood the test of time and continues to inspire the advancement of the Renaissance values of learning and wisdom for the benefit of future generations. Held on 12 and 13 December 2024, the 5th in-person Consortium Meeting was attended by representatives of all the MammoScreen partners and by the External experts advisory board members together with the project´s Patient Advisory Group Coordinator. The IMT team, hosting the meeting, took the opportunity to highlight their recent literature review examining the clinical effectiveness of AI-based systems in the detection of breast cancer. Their work compares the clinical effectiveness of AI-based systems, pinpointing the lack of cost-effectiveness analysis particularly in microwave imaging and highlighting important research gaps and challenges for the integration of these systems into clinical workflows. The IMT team also presented the progress made in the HTA (Health technology Assessment) model that is being developed in parallel to the clinical trial, to support introduction of MammoWave in clinical uptake. The HTA mathematical model is ready for the interim analysis planned after recruitment of the first 3000 volunteers. The Sponsor UBT with the support of the CRO, JSB solution, have been carefully monitoring the recruiting centers and were happy to confirm that this important milestone will be achieved at the start of 2025, as planned. During the meeting, our clinical partner SESCAM presented a comparison of the performance of MammoWave between all the recruiting clinical centers, revealing important improvements in the key performance indicators of the AI-based analysis of MammoWave signals achieved by our LSBU partners. The LSBU team has been working hard to improve the data analysis method and has recently published their most recent optimization of the AI-based classification. On the medical device front, UBT engineers are promptly addressing feedback from the clinical centers to improve the hardware aspects of the microwave signal acquisition. This is aimed at rendering MammoWave more robust and user-friendly from the technical point of view, improving the analytical workflow. EVITA, together with TLS, reported on the achievements of the communication and dissemination strategy and listened to feedback from the various participants regarding the plan for upcoming social media campaigns and other activities. Consensus was reached around the need for improved focus on technology and how it is perceived by those that will potentially benefit from it. Overall, Italy is a very welcoming country, and it was without much effort that the Consortium agreed to have the next in-person meeting hosted by UBT, during June 2025 (date to be confirmed), in Assisi, Perugia. Arrivederci, Italia! Together, we aim to improve breast cancer screening provide a safer, more accessible, and comfortable alternative. Stay informed about our progress by subscribing to our Newsletter and following us on social media.
MammoScreen answers questions frequently asked by clinical trial participants
We understand that joining a research study is a significant decision. Therefore, we ensure that participants fully understand the scope of the MammoScreen trial, its purpose, and any potential risks or benefits involved. In this issue, we publish some of the most common questions asked by volunteers before they undergo a MammoWave scan answered by the experts that supervise the clinical trial protocol. These questions cover different aspects of the study´s goals, safety protocols, and what to expect throughout the process. Obtaining informed consent respects each participant’s autonomy and allows them to make a well-informed decision about whether or not to participate. This commitment to transparency and ethical standards helps to protect the participant´s well-being and upholds the integrity of the research outcome. There are many reasons why a person might choose to participate in a clinical study, including a desire to help others, advance science, or contribute to meaningful change. We give our heartfelt thanks to all those volunteering in the MammoScreen trial and to the clinical teams involved in the recruitment process in Italy, Poland, Portugal, Spain and Switzerland – Grazie, Dziękuję, Obrigado, Gracias, Danke! Participant (P): Will the MammoWave test expose me to any radiation? MammoScreen (MS): No, MammoWave does not use ionizing radiation, unlike conventional mammography. It uses microwave imaging technology, which is non-ionizing and considered safe for repeated use. This is one of the potential advantages of MammoWave, especially for individuals who require frequent monitoring. P: Is the MammoWave scan painful or uncomfortable? MS: Unlike traditional mammograms, which may cause some discomfort due to compression, MammoWave does not require compression of the breast, making the experience generally more comfortable for most patients. Participants typically find it to be a painless process, though experiences may vary slightly. P: I have small breasts, and they don’t seem to fit well into the MammoWave cup. Will my breasts still be scanned accurately? MS: We are still exploring the device’s field of view and how well it can scan smaller breasts. This is one of the factors being studied to ensure that MammoWave can provide accurate imaging across a range of breast sizes and shapes. P: I once came to the hospital because I felt a lump in my armpit, but the mammogram showed everything was normal. Does this test scan the axillary (armpit) region? MS: At present, the MammoWave test does not include the axillary region in its scan. It is focused on imaging breast tissue rather than areas outside the primary breast zone. This is an area that could be explored in future studies, especially if scanning the axilla proves beneficial for detecting certain types of breast cancer. P: How can I access my personal results from the MammoWave test? Will I receive a report? MS: There are currently no official reports from MammoWave that are integrated into the clinical diagnostic pathway. According to the clinical protocol, your mammogram results serve as the official screening outcome, and these are communicated to you as per the hospital’s standard procedures. If you have dense breast tissue and MammoWave detects a potentially suspicious lesion, an additional ultrasound will be performed, and you will receive those results as well, according to the study clinical protocol. P: Will the MammoWave test results affect my clinical care or follow-up? MS: For now, MammoWave results are only being used for research purposes and do not influence your clinical care directly. Your care and followup are based on traditional screening methods, such as mammography and ultrasound, which are established parts of the clinical pathway. P: When will the MammoWave test be available for regular screening use? MS: One of the main goals of MammoScreen is to generate evidence at NHS level to possibly include MammoWave test for regular screening use. P: Could MammoWave replace mammography in the future? MS: It’s too early to say. New technologies must go through rigorous testing to confirm that they are safe, effective, and provide additional benefits over existing methods. While MammoWave has potential, it would need to demonstrate comparable or superior accuracy in detecting breast cancer compared to mammography. Only after extensive research and evaluation by scientific bodies and national health systems it could be considered as a potential alternative to mammography. However, MammoWave could also be considered complementary to mammography towards a more inclusive screening.
Managing clinical aspects of the MammoScreen trial
SESCAM (Servicio de Salud de Castilla-La Mancha) is the public health service responsible for managing healthcare across Castilla-La Mancha, Spain. Established in 2002, SESCAM provides healthcare services to over two million people, encompassing primary care, specialized care, emergency services, and public health programs across a network of health centres, hospitals and clinics. SESCAM’s mission is to deliver comprehensive, high-quality, and universal healthcare, free at the point of access. The organization prioritizes preventive healthcare programs — such as vaccination campaigns, cancer screening, and health education—to enhance public health outcomes in Castilla-La Mancha. With a commitment to improving quality and accessibility, SESCAM also emphasizes digital services for patients, aiming to bridge healthcare gaps in rural areas and meet rising demands in a growing population. The SESCAM team involved in the MammoScreen project is based in the Radiology Department at the University Hospital of Toledo. Led by Dr. Cristina Romero Castellano, an expert in the use of AI in mammography, the team is based on a research group – Group in Clinical Research Applied to Diagnostic Imaging (Grupo de Investigación Clínica Aplicada al Diagnóstico por Imagen, ICADI), that includes experienced breast radiologists, biomedical engineers, and a dedicated project manager. Currently, the Breast Radiology Unit at SESCAM oversees the Regional Early Detection Program for Breast Cancer, serving approximately 85,000 women in the Toledo healthcare region. The clinical team is committed to continually optimizing protocols and incorporating new devices and methodologies to improve diagnostic accuracy and efficiency. This commitment to innovation has earned SESCAM recognition from the European Commission, including an award for best practices in breast cancer diagnosis and management (Optimized Population-Based Screening and Diagnostic Pathway for Breast Cancer Detection, Best Practices in NCD Prevention 2021). Role of SESCAM in the MammoScreen Consortium Within the MammoScreen Consortium, SESCAM is responsible for developing the clinical trial protocol and related documentation. SESCAM ensures a cohesive approach across all participating recruitment centres, working closely with the UBT team and the CRO to create an electronic case report form (e-CRF) that simplifies data collection. The dedicated clinical trial protocol has been recently published in BMJ Open. As the project’s clinical coordinator, SESCAM oversees clinical ethics and recruitment strategies and ensures that standard screening data from mammograms and other radiological or histological sources are accurately captured in the e-CRF. This standardization aligns the trial’s outcomes with European guidelines on breast cancer screening and diagnosis. As this is a novel technology, there are currently no established guidelines or recommendations for its use in breast lesion or breast cancer detection. The absence of official endorsements from scientific societies at the national, European, and international levels reflects the need for a stronger base of scientific evidence. For instance, through the MammoScreen project, SESCAM and its Consortium Partners are working together to build this crucial evidence base, aiming to drive a paradigm shift in breast cancer screening and diagnosis. Collaborative Efforts and Community Engagement SESCAM plays a vital role in engaging with a diverse group of stakeholders, including clinical and regulatory authorities and end users—primarily women in the general population who are invited for breast screening. To support these activities, SESCAM collaborates closely with the ELAROS team in developing the clinical web portal and user-friendly mobile app, which are key outcomes of the MammoScreen Project. Additionally, SESCAM is instrumental in organizing workshops with clinicians to promote knowledge sharing and esure alignment with the project’s goals. Advancing Breast Healthcare Through Innovation SESCAM’s contribution to the MammoScreen Project is essential for integrating MammoWave into established breast imaging standards, paving the way for this innovative screening technology to become a part of routine breast healthcare. Stay tuned to the MammoScreen communication channels as well to learn more about their activities in the project. You can keep up with SESCAM´s team activities by following their social networks: Instagram, X, Facebook, and LinkedIn.
Assessing progress and planning for the future with the first MammoScreen Review Report
The MammoScreen Project reached its mid-term milestone last November, and the Consortium took the opportunity to celebrate achievements and identify upcoming challenges. A key highlight of this moment was the elaboration of the first Project Review Report, a comprehensive assessment of the project´s progress, finances, and areas for improvement. Submitted to the tight scrutiny of the European Commission, the report was a great opportunity to ensure that the project remains aligned with its goals and that its stakeholders have an accurate understanding of the progress made in the clinical trial and accompanying activities. The main conclusion of the Review Report was that significant strides have been made in the previous six months: MammoWave devices were installed in all the testing centers, and the recruitment of clinical trial participants is well on track for the performance checkpoint planned for January 2025. The evaluators also praised the efforts made towards project components such as the MammoScreen App, scientific publications, and dissemination and communication strategies. In the opinion of our evaluators, MammoScreen has shown remarkable success in promoting an innovative approach to breast health. In their words, the project is a “pioneering effort and an impressive response to the gaps in early breast cancer detection, especially for populations often deterred by traditional mammography due to discomfort or the need for radiation exposure”. In fact, the technology could become particularly relevant for younger women and those with dense breast tissue who may not benefit fully from conventional imaging techniques. Feedback gathered from users so far has highlighted MammoWave as comfortable and easy to use, which is crucial for its long-term adoption. Overall, the MammoScreen project was considered an exemplary model of a well executed medical innovation initiative that addresses real patient needs. MammoScreen’s rigorous data collection, realtime monitoring, and participant-centered approach holds a high standard for medical innovation. The Review Report highlighted the Consortium´s commitment to adhere to stringent data management and clinical procedures, ensuring reliable results and high quality conclusions will be obtained at the end of the project. The evaluators recognized that the successful combination of effective recruitment, data analysis and outreach reinforce the potential of MammoWave as a revolutionary tool in breast health and sets a strong precedent for future advancements in patient-centered medical device development.
Clinical trial recruitment: update and plans for the future
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.
