RecruitingNot ApplicableNCT06291896

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

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


Sponsor

Umbria Bioengineering Technologies

Enrollment

10,000 participants

Start Date

Mar 15, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 45 YearsMax Age: 74 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new breast imaging device called MammoWave as a companion to standard mammograms — with the goal of finding breast cancer earlier. You may be eligible if: - You are a woman between 45 and 74 years old - You have no breast cancer symptoms right now - You are considered average risk (no known BRCA1, BRCA2, or TP53 gene changes, and no personal history of breast cancer) - You have had or are planning to have a mammogram around the same time as this study - You are willing to follow the study's guidelines You may NOT be eligible if: - You have breast implants - You have any symptoms or signs that might suggest breast cancer - You carry a BRCA1, BRCA2, or TP53 gene variant, or have had breast cancer before - You are currently pregnant - Your breast size is larger than the biggest available cup size for the MammoWave device - Your cancer was only found in a lymph node under your arm with no sign of it in the breast itself Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEMammoWave

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

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NCT06291896