protocolSection identificationModule nctId: NCT06291896, orgStudyIdInfo id: UBT 2023-01, briefTitle: A Clinical Investigation to Evaluate Microwave Imaging Via MammoWave® in a Population-based Screening Program for Early Breast Cancer Detection, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2026-02-15, completionDateStruct date: 2026-12-15, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Umbria Bioengineering Technologies, class: INDUSTRY, collaborators name: Toscana Life Sciences Sviluppo s.r.l., collaborators name: London South Bank University, collaborators name: ELAROS 24/7 Limited (UK), collaborators name: Servicio De Salud De Castilla La Mancha (Spain), collaborators name: IMT School for Advanced Studies Lucca, collaborators name: EVITA - Cancro Hereditário (Portugal), descriptionModule briefSummary: 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., conditionsModule conditions: Women's Health: Neoplasm of Breast, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Clinical Investigation with class IIa medical device, primaryPurpose: SCREENING, maskingInfo masking: NONE, enrollmentInfo count: 10000, type: ESTIMATED, armsInterventionsModule interventions name: MammoWave, outcomesModule primaryOutcomes measure: MammoWave® sensitivity, primaryOutcomes measure: MammoWave® specificity, secondaryOutcomes measure: Detection rates by type of lesion, secondaryOutcomes measure: Recall rate, secondaryOutcomes measure: Positive-predictive value, secondaryOutcomes measure: Program screening rate, secondaryOutcomes measure: BC detection rates of each by histological type and size of the BC and BI-RADS classification, also by breast density, secondaryOutcomes measure: MammoWave® sensitivity and specificity after retrospective AI adjustment using the data at the end of the study, secondaryOutcomes measure: Agreement between different evaluator (i.e. local versus central), secondaryOutcomes measure: Volunteers' satisfaction questionnaire, eligibilityModule sex: FEMALE, minimumAge: 45 Years, maximumAge: 74 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ospedale San Giovanni Battista - USL Umbria 2, status: NOT_YET_RECRUITING, city: Foligno, state: Perugia, zip: 06034, country: Italy, contacts name: Riccardo Loretoni, role: CONTACT, email: riccardo.loretoni@uslumbria2.it, contacts name: Riccardo Loretoni, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.95488, lon: 12.70268, locations facility: IRCCS Policlinico San Martino, status: RECRUITING, city: Genova, zip: 16132, country: Italy, contacts name: Massimo Calabrese, role: CONTACT, email: massimo.calabrese@hsanmartino.it, contacts name: Massimo Calabrese, role: PRINCIPAL_INVESTIGATOR, contacts name: Alberto Stefano Tagliafico, role: SUB_INVESTIGATOR, geoPoint lat: 44.40478, lon: 8.94438, locations facility: Pomeranian Medical University Hospital, status: NOT_YET_RECRUITING, city: Szczecin, country: Poland, contacts name: Jan Lubinsky, role: CONTACT, email: jan.lubinski@pum.edu.pl, contacts name: Jan Lubinsky, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 53.42894, lon: 14.55302, locations facility: Champalimaud Foundation, status: NOT_YET_RECRUITING, city: Lisboa, country: Portugal, contacts name: Filipa Lourenço Cardoso, role: CONTACT, email: filipa.cardoso@research.fchampalimaud.org, contacts name: Celeste Alves, role: PRINCIPAL_INVESTIGATOR, contacts name: Maria Antónia Vasconcelos, role: SUB_INVESTIGATOR, geoPoint lat: 38.71667, lon: -9.13333, locations facility: Clínica Dr. Passos Ângelo in Lisbon, status: NOT_YET_RECRUITING, city: Lisboa, country: Portugal, contacts name: Ângelo Passos, role: CONTACT, email: epassosangelo@gmail.com, contacts name: Ângelo Passos, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.71667, lon: -9.13333, locations facility: Hospital Universitario Reina Sofía- Córdoba, status: NOT_YET_RECRUITING, city: Córdoba, country: Spain, contacts name: Marina Álvarez Benito, role: CONTACT, email: marinaalvarezbenito@telefonica.net, contacts name: Marina Álvarez Benito, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.89155, lon: -4.77275, locations facility: Hospital General Universitario Morales Meseguer, status: NOT_YET_RECRUITING, city: Murcia, country: Spain, contacts name: María Martínez Gálvez, role: CONTACT, email: martinezgalvez@gmail.com, contacts name: María Martínez Gálvez, role: PRINCIPAL_INVESTIGATOR, contacts name: Este Correo, role: SUB_INVESTIGATOR, geoPoint lat: 37.98704, lon: -1.13004, locations facility: Complejo Hospitalario Universitario de Toledo, status: NOT_YET_RECRUITING, city: Toledo, country: Spain, contacts name: Daniel Alvarez Sánchez-Bayuela, role: CONTACT, email: danialsanba@gmail.com, contacts name: Cristina Romero Castellano, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.8581, lon: -4.02263, locations facility: Diagnostic and Interventional Radiology, University Hospital Zurich, status: NOT_YET_RECRUITING, city: Zürich, country: Switzerland, contacts name: Thomas Frauenfelder, role: CONTACT, email: thomas.frauenfelder@usz.ch, contacts name: Thomas Frauenfelder, role: PRINCIPAL_INVESTIGATOR, contacts name: Jann Wieler, role: SUB_INVESTIGATOR, geoPoint lat: 47.36667, lon: 8.54999, hasResults: False