Periodic Reporting for period 1 - MammoScreen (Innovative and safe microwave-based imaging technology to make breast cancer screening more accurate, inclusive and female-friendly)
Reporting period: 2022-12-01 to 2024-05-31
Breast cancer is the most common cancer in women: 1 in 11 women is affected by age 74 . Mammography-based screening programmes show strong performance but present drawbacks, such as the uses of x-rays and low efficacy in dense breasts. There's a demand for more inclusive screening that considers various risk factors and societal barriers to access. MammoScreen project aims to tackle these issues to reduce the burden of breast cancer in Europe and beyond. The main aim is to provide evidence on the efficacy of the microwaves-based device MammoWave to improve breast cancer screening. This device, CE marked, is tested on 10,000 women included in national and regional screening programmes. MammoWave uses non-ionizing radiation, requires no special infrastructure or operator training. The data captured during the exam are elaborated with the support of a machine-learning augmented software, giving information on the eventual presence of lesions in the breast tissue. During the project a Health Technology Assessment will be performed to evaluate the cost-effectiveness, willingness-to-pay thresholds, and impact on improved quality of life, a critical step given the lack of existing literature on microwave-based technologies in HTA context. Patient, community and public stakeholders’ involvement is designed with different work packages, to allow the assessment of a correct approach to the project tasks , ensuring a patient-centred set-up. Building trust in new medical technologies requires a collaborative effort among regulators, healthcare professionals, and patients to balance market uptake, trustworthiness, and safety. This synergy is essential for the timely introduction of innovations like MammoWave, to improve long-term healthcare outcomes while being aligned with aligning EU Mission Cancer aims.
During the first reporting period, the following activities were implemented.
I)External experts boards and Patient advisory group coordinator establishment: Since the beginning, the consortium appointed two boards of external experts (Scientific and Data&Ethics) and a patient advocate to support MammoScreen activities. Their role is very active, and they were involved in different pillar tasks, such as the development of the protocol and the ethical support for dissemination activities oriented to patients. The experts participate all the in-person consortium meeting.
II) Clinical trial set up and execution: clinical protocol development was the most challenging activity of the first RP, as it adsorbed most of the first year of activities and faced difficulties or delays when approaching bureaucracy. During the first in person consortium meeting in London, an intensive discussion was established by involving project’s External Experts Advisory Boards. This was necessary to understand how to correctly define the objective of the study, based on preliminary results (from previous trials) and available resources. Ethical aspects were tackled together with scientific requirement and a preliminary draft was produced by SESCAM and UBT. The support of a CRO was thus inescapable, by considering the complexity of the scenario that still accompanies the clinical investigation, such as dealing with all the requirement belonging to Medical Device Regulation and local authorities for the study approvals. CRO’s Medical writer and statistician contributed to defining the statistical sample and outcomes, and PIs from the involved centres were asked to integrate and review the manuscript. Final version was obtained and presented to authorities for approvals. The complete pathway, together with Contract negotiation and execution, required more effort than expected. One of the main challenges was coordination between the 9 sites, that adopt their own institutional protocols, centre-specific templates, regulatory requirements, and logistical considerations. The communication between sites and different internal procedures further hampered a smooth process but also increasing costs of the clinical study management.
III) HTA review on European Breast Cancer screening programmes
IV) Development of the PPIE tools: ELAROS worked on the development of two digital tools which would improve MammoWave experience by engaging patients, clinicians and citizens with the support of EVITA. Specifically, a Patient facing app and a clinical web portal are under implementation. To gather initial insights from direct users, a survey and webinars (described in the dedicated deliverable) were administered to women (with and without experience with cancer) and provided with feedback on expectation and important inputs for the mobile app. ELAROS also organised dedicated meetings with medical stuff from the clinical enrolment centres. These dialogues were necessary to identify the opportune strategy for the web portal design, that aim to be a bridge between clinicians and women which will use MammoWave. As the clinical study is still running, preliminary inputs received by Inputs from Stakeholders are suggesting the possibility of positioning MammoWave as a screening device for specific targets of women at high risk or with dense breasts. The consortium is thus working on defining necessary measurement to be adopted for this aim.
I)External experts boards and Patient advisory group coordinator establishment: Since the beginning, the consortium appointed two boards of external experts (Scientific and Data&Ethics) and a patient advocate to support MammoScreen activities. Their role is very active, and they were involved in different pillar tasks, such as the development of the protocol and the ethical support for dissemination activities oriented to patients. The experts participate all the in-person consortium meeting.
II) Clinical trial set up and execution: clinical protocol development was the most challenging activity of the first RP, as it adsorbed most of the first year of activities and faced difficulties or delays when approaching bureaucracy. During the first in person consortium meeting in London, an intensive discussion was established by involving project’s External Experts Advisory Boards. This was necessary to understand how to correctly define the objective of the study, based on preliminary results (from previous trials) and available resources. Ethical aspects were tackled together with scientific requirement and a preliminary draft was produced by SESCAM and UBT. The support of a CRO was thus inescapable, by considering the complexity of the scenario that still accompanies the clinical investigation, such as dealing with all the requirement belonging to Medical Device Regulation and local authorities for the study approvals. CRO’s Medical writer and statistician contributed to defining the statistical sample and outcomes, and PIs from the involved centres were asked to integrate and review the manuscript. Final version was obtained and presented to authorities for approvals. The complete pathway, together with Contract negotiation and execution, required more effort than expected. One of the main challenges was coordination between the 9 sites, that adopt their own institutional protocols, centre-specific templates, regulatory requirements, and logistical considerations. The communication between sites and different internal procedures further hampered a smooth process but also increasing costs of the clinical study management.
III) HTA review on European Breast Cancer screening programmes
IV) Development of the PPIE tools: ELAROS worked on the development of two digital tools which would improve MammoWave experience by engaging patients, clinicians and citizens with the support of EVITA. Specifically, a Patient facing app and a clinical web portal are under implementation. To gather initial insights from direct users, a survey and webinars (described in the dedicated deliverable) were administered to women (with and without experience with cancer) and provided with feedback on expectation and important inputs for the mobile app. ELAROS also organised dedicated meetings with medical stuff from the clinical enrolment centres. These dialogues were necessary to identify the opportune strategy for the web portal design, that aim to be a bridge between clinicians and women which will use MammoWave. As the clinical study is still running, preliminary inputs received by Inputs from Stakeholders are suggesting the possibility of positioning MammoWave as a screening device for specific targets of women at high risk or with dense breasts. The consortium is thus working on defining necessary measurement to be adopted for this aim.
As the clinical study is still running, preliminary inputs received from Stakeholders are suggesting the possibility of positioning MammoWave as a screening device for specific targets of women, such as: at high risk; with dense breast; young women. The consortium is thus working on defining necessary measurements to be adopted for this aim.