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