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NCT06291896Recruiting

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

Official recordSimplified version

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.

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

Contacts

The trial team's contact details are shown on request.

See the official trial record
Status
Recruiting
Phase
No phase (N/A)
Study type
Interventional
Countries
Switzerland, Italy, Poland, Portugal, Spain
Sponsor
Umbria Bioengineering Technologies(Industry)
Protocol no.
UBT 2023-01
Conditions
Women's Health: Neoplasm of Breast
Interventions
Device

Treatments studied

  • MammoWave

Collaborators

London South Bank University, ELAROS 24/7 Limited (UK), Servicio De Salud De Castilla La Mancha (Spain), IMT School for Advanced Studies Lucca, EVITA - Cancro Hereditário (Portugal), Fondazione Toscana Life Sciences (Italy)

Locations · 10

  • Zurich, SwitzerlandDiagnostic and Interventional Radiology, University Hospital ZurichRecruiting at this site
  • Genova, ItalyIRCCS Policlinico San MartinoRecruiting at this site
  • Foligno, ItalyOspedale San Giovanni Battista - USL Umbria 2Recruiting at this site
  • Trieste, ItalyAz. San. Univ. Giuliano Isontina (ASU GI)Recruiting at this site
  • Szczecin, PolandPomeranian Medical University HospitalRecruiting at this site
  • Lisbon, PortugalChampalimaud FoundationRecruiting at this site
  • Lisbon, PortugalClínica Dr. Passos Ângelo in LisbonRecruiting at this site
  • Córdoba, SpainHospital Universitario Reina Sofía- CórdobaRecruiting at this site
  • Murcia, SpainHospital General Universitario Morales MeseguerRecruiting at this site
  • Toledo, SpainComplejo Hospitalario Universitario de ToledoRecruiting at this site

In total, worldwide, all 10 sites listed in the registry are recruiting.

Site status per the ClinicalTrials.gov registry (last update posted: May 13, 2026).

This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.

See also

Other versions

These results are indicative and do not replace medical advice — discuss them with your doctor.