Evaluating Microwave Imaging for Early Breast Cancer Detection
A Multicentric, Prospective Clinical Investigation to Evaluate Microwave Imaging Via MammoWave® in a Population-based Screening Program for Early Breast Cancer Detection to Make Breast Cancer Screening More Accurate, Inclusive, and Female-friendly
This study is testing a new device called MammoWave that uses microwaves to see if it can help find breast cancer earlier in women who are already getting routine screenings.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10000 (estimated) |
| Ages | 45 Years to 74 Years |
| Sex | Female |
| Sponsor | Umbria Bioengineering Technologies Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 10 sites (Genova, Genova and 9 other locations) |
| Trial ID | NCT06291896 on ClinicalTrials.gov |
What this trial studies
This clinical investigation aims to assess the effectiveness of the MammoWave device in detecting breast cancer among 10,000 women participating in routine screening programs. The study will measure the sensitivity and specificity of MammoWave, which utilizes low-power microwaves instead of ionizing radiation for breast cancer screening. Participants will undergo both conventional mammography and MammoWave examinations, with results compared against established reference standards. The study is designed to enhance early detection methods for breast cancer while ensuring patient safety.
Who should consider this trial
Good fit: Ideal candidates for this study are asymptomatic women aged 45 to 74 years with an average risk of breast cancer.
Not a fit: Patients with breast prostheses, known breast cancer, or those who are pregnant will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a safer and more effective method for early breast cancer detection.
How similar studies have performed: Previous studies using microwave imaging for breast cancer detection have shown promise, but this specific approach with MammoWave is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women aged between 45 and 74 years * Asymptomatic * Signed informed consent form before starting any study activity * Average risk of BC (every woman except those with know BRCA1, 2, TP53, and/or previous BC) * Mammographic test, either 2D FFDM or 3D Digital Breast Tomosynthesis (DBT) (collecting oblique mediolateral projection \[MLO\] of the right breast, craniocaudal projection \[CC\] of the right breast, MLO projection of the left breast, CC projection of the left breast), performed within the past month with available results or planned to be performed in the same day of the MammoWave test or in the subsequent days * Spontaneous willingness to comply with CIP and recommendations Exclusion Criteria: * Woman with breast prostheses * Women with symptoms or some sign of suspected BC * Women with BRCA1, 2, TP53 or previous BC * Pregnant women * Women who do not have mammographic manifestation of the tumor (known occult breast tumor with only axillar manifestation) * Women with breast size larger than the largest MammoWave cup size
Where this trial is running
Genova, Genova and 9 other locations
- IRCCS Policlinico San Martino — Genova, Genova, Italy (Recruiting)
- Ospedale San Giovanni Battista - USL Umbria 2 — Foligno, Perugia, Italy (Recruiting)
- Az. San. Univ. Giuliano Isontina (ASU GI) — Trieste, Italy (Recruiting)
- Pomeranian Medical University Hospital — Szczecin, Poland (Recruiting)
- Champalimaud Foundation — Lisbon, Portugal (Recruiting)
- Clínica Dr. Passos Ângelo in Lisbon — Lisbon, Portugal (Recruiting)
- Hospital Universitario Reina Sofía- Córdoba — Córdoba, Spain (Recruiting)
- Hospital General Universitario Morales Meseguer — Murcia, Spain (Recruiting)
- Complejo Hospitalario Universitario de Toledo — Toledo, Spain (Recruiting)
- Diagnostic and Interventional Radiology, University Hospital Zurich — Zurich, Switzerland (Recruiting)
Study contacts
- Study coordinator: Gianluigi Tiberi
- Email: gianluigi@ubt-tech.com
- Phone: 0039 3490564302
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.