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

Summary

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.

Eligibility

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

Conditions3

Browse More Trials