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

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.

ClinicalTrials.gov IDNCT06291896

PhaseNA

Enrollment10000

SponsorUmbria Bioengineering Technologies

Age45 Years

SexFEMALE

I'm interested View official listing

Conditions studied

Women's Health: Neoplasm of Breast

About this study

Interventions

Device: MammoWave — Women undergoing conventional breast screening examination will be asked by the clinical staff if they are interested in taking part in the study. A short visit should be performed to check the inclusion/exclusion criteria, review demographic data, and the volunteer's medical history. After performing this visit, the volunteers will perform the MammoWave exam on both their breasts. The exam will be composed of two phases: data acquisition and data processing. During the acquisition, which should take about 8 minutes, the volunteers would be lying down in a prone position, on the bed which is part of MammoWave. When the acquisition is completed, the data will be processed through a dedicated microwave imaging algorithm. The output will be composed of microwave images, plus parameters describing the images. MammoWave output will also comprise a label obtained using an optimized classification algorithm.

Primary outcomes

MammoWave® sensitivity (During the procedure)
MammoWave® specificity (During the procedure)

Eligibility information

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

Study locations

IRCCS Policlinico San Martino, Genova, Genova 16132 Italy
Ospedale San Giovanni Battista - USL Umbria 2, Foligno, Perugia 06034 Italy
Az. San. Univ. Giuliano Isontina (ASU GI), Trieste, 34128 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
Complejo Hospitalario Universitario de Toledo, Toledo, Spain
Diagnostic and Interventional Radiology, University Hospital Zurich, Zurich, Switzerland

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.