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

NCT06291896 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10000

Last updated 2026-05-13

No results posted yet for this study

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.

Conditions

  • Women's Health: Neoplasm of Breast

Interventions

DEVICE

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.

Sponsors & Collaborators

  • London South Bank University

    collaborator OTHER

  • ELAROS 24/7 Limited (UK)

    collaborator UNKNOWN

  • Servicio De Salud De Castilla La Mancha (Spain)

    collaborator UNKNOWN

  • IMT School for Advanced Studies Lucca

    collaborator OTHER

  • EVITA - Cancro Hereditário (Portugal)

    collaborator UNKNOWN

  • Fondazione Toscana Life Sciences (Italy)

    collaborator UNKNOWN

  • Umbria Bioengineering Technologies

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
45 Years
Max Age
74 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-03-15
Primary Completion
2026-06-30
Completion
2026-12-15

Countries

  • Italy
  • Poland
  • Portugal
  • Spain
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06291896 on ClinicalTrials.gov