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.