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A Clinical Investigation to Evaluate Microwave Imaging Via MammoWave® in a Population-based Screening Program for Early Breast Cancer Detection
Sponsor: Umbria Bioengineering Technologies
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.
Official title: A Multicentric, Prospective Clinical Investigation to Evaluate Microwave Imaging Via MammoWave® in a Population-based Screening Program for Early Breast Cancer Detection to Make Breast Cancer Screening More Accurate, Inclusive, and Female-friendly
Key Details
Gender
FEMALE
Age Range
45 Years - 74 Years
Study Type
INTERVENTIONAL
Enrollment
10000
Start Date
2024-03-15
Completion Date
2026-12-15
Last Updated
2025-01-06
Healthy Volunteers
Yes
Conditions
Interventions
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.
Locations (9)
Ospedale San Giovanni Battista - USL Umbria 2
Foligno, Perugia, Italy
IRCCS Policlinico San Martino
Genova, 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