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A Clinical Investigation to Evaluate Microwave Imaging Via MammoWave® in a Population-based Screening Program for Early Breast Cancer Detection

RecruitingNAAges 45 Years - 74 YearsFemaleUmbria Bioengineering Technologies
NCT06291896 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This is an open, multicentric, interventional, prospective, non-randomized clinical investigation. The first aim of the study is to confirm that MammoWave reaches sensitivity\>75% and specificity\>90% in breast cancer (BC) detection on 10.000 volunteers undergoing regular screening programs.

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📋 Eligibility rules (as published)
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
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What it tests

  • MammoWave
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Where

10 sites
IRCCS Policlinico San Martino
Genova, Italy
Ospedale San Giovanni Battista - USL Umbria 2
Foligno, Italy
Az. San. Univ. Giuliano Isontina (ASU GI)
Trieste, Italy
Pomeranian Medical University Hospital
Szczecin, Poland
Champalimaud Foundation
Lisbon, Portugal
Clínica Dr. Passos Ângelo in Lisbon
Lisbon, Portugal
Hospital Universitario Reina Sofía- Córdoba
Córdoba, Spain
Hospital General Universitario Morales Meseguer
Murcia, Spain

…and 2 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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