Actively Recruiting

Phase Not Applicable
Age: 45Years - 74Years
FEMALE
Healthy Volunteers
NCT06291896

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

Led by Umbria Bioengineering Technologies · Updated on 2026-05-13

10000

Participants Needed

10

Research Sites

143 weeks

Total Duration

On this page

Sponsors

U

Umbria Bioengineering Technologies

Lead Sponsor

L

London South Bank University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 45Years - 74Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Women aged between 45 and 74 years
  • Asymptomatic at the time of screening
  • Signed informed consent before any study procedures
  • Average breast cancer risk (no known BRCA1, BRCA2, TP53 mutations, or previous breast cancer)
  • Mammogram performed within the past month or planned on the same or following days as MammoWave test
  • Willingness to comply with study instructions and recommendations
Not Eligible

You will not qualify if you...

  • Presence of breast prostheses
  • Symptoms or signs of suspected breast cancer
  • Known BRCA1, BRCA2, TP53 mutations or previous breast cancer diagnosis
  • Pregnancy
  • Breast tumor without mammographic signs (occult tumor with only axillary manifestation)
  • Breast size larger than the largest MammoWave cup size

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 10 locations

1

IRCCS Policlinico San Martino

Genova, Genova, Italy, 16132

Actively Recruiting

2

Ospedale San Giovanni Battista - USL Umbria 2

Foligno, Perugia, Italy, 06034

Actively Recruiting

3

Az. San. Univ. Giuliano Isontina (ASU GI)

Trieste, Italy, 34128

Actively Recruiting

4

Pomeranian Medical University Hospital

Szczecin, Poland

Actively Recruiting

5

Champalimaud Foundation

Lisbon, Portugal

Actively Recruiting

6

Clínica Dr. Passos Ângelo in Lisbon

Lisbon, Portugal

Actively Recruiting

7

Hospital Universitario Reina Sofía- Córdoba

Córdoba, Spain

Actively Recruiting

8

Hospital General Universitario Morales Meseguer

Murcia, Spain

Actively Recruiting

9

Complejo Hospitalario Universitario de Toledo

Toledo, Spain

Actively Recruiting

10

Diagnostic and Interventional Radiology, University Hospital Zurich

Zurich, Switzerland

Actively Recruiting

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Research Team

G

Gianluigi Tiberi

CONTACT

S

Sabatino Tiberi

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

SCREENING

Number of Arms

1

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