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

May 6, 2024 updated by: Umbria Bioengineering Technologies

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

MammoWave is a non-CE marked device that uses low-power (1mW) microwaves (1-9 GHz) instead of ionizing radiation (X-ray) for BC screening. MammoWave uses safe low-power radio frequency signals in the microwave band; it is a Class IIa medical device (non-invasive device). The previous generation of MammoWave had obtained the CE mark; in this investigation, the device contains the same hardware and will be used with the same acquisition method as the CE marked device, but additional data processing software will be used.

The 10,000 volunteers undergoing conventional breast screening examination will also undergo the MammoWave exam. The MammoWave results (WSF: breast With Suspicious Finding,i.e. with suspicious lesion, or NSF: No Suspicious Finding, i.e. breast without lesion or with low suspicious lesion) will be checked against the Reference Standard, to be intended as the output of conventional breast examination path (i.e., screening mammogram, integrated with other radiological/histological output when deemed necessary by the responsible Investigator in each site). Reference Standard may be BC+ for the histology-confirmed breast cancer (BI-RADS 6); BC- otherwise (BI-RADS 1, 2, 3).

(NOTE: BIRADS 4 and 5 are only image suspicion criteria: when a biopsy is performed, BIRADS are transformed in 6 (BC+) or 1,2 and 3 (BC-))

This clinical trial is performed within MammoScreen project [1] awarded in the context of HORIZON-MISS-2021-CANCER-02-01. UBT Srl is a partner of a Consortium which comprises (in addition to UBT): Toscana Life Sciences Foundation (Italy); London South Bank University (UK); ELAROS 24/7 Limited (UK); Servicio De Salud De Castilla La Mancha (Spain); Scuola IMT Alti Studi Lucca (Italy); EVITA - Cancro Hereditário (Portugal).

Study Type

Interventional

Enrollment (Estimated)

10000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Genova, Italy, 16132
        • Recruiting
        • IRCCS Policlinico San Martino
        • Contact:
        • Principal Investigator:
          • Massimo Calabrese
        • Sub-Investigator:
          • Alberto Stefano Tagliafico
    • Perugia
      • Foligno, Perugia, Italy, 06034
        • Recruiting
        • Ospedale San Giovanni Battista - USL Umbria 2
        • Contact:
        • Principal Investigator:
          • Riccardo Loretoni
  • Poland
      • Szczecin, Poland
        • Not yet recruiting
        • Pomeranian Medical University Hospital
        • Contact:
        • Principal Investigator:
          • Jan Lubinsky
  • Portugal
      • Lisboa, Portugal
      • Lisboa, Portugal
        • Recruiting
        • Clínica Dr. Passos Ângelo in Lisbon
        • Contact:
        • Principal Investigator:
          • Ângelo Passos
  • Spain
      • Córdoba, Spain
        • Not yet recruiting
        • Hospital Universitario Reina Sofía- Córdoba
        • Contact:
        • Principal Investigator:
          • Marina Álvarez Benito
      • Murcia, Spain
        • Not yet recruiting
        • Hospital General Universitario Morales Meseguer
        • Contact:
        • Principal Investigator:
          • María Martínez Gálvez
        • Sub-Investigator:
          • Este Correo
      • Toledo, Spain
        • Not yet recruiting
        • Complejo Hospitalario Universitario de Toledo
        • Contact:
        • Principal Investigator:
          • Cristina Romero Castellano
  • Switzerland
      • Zürich, Switzerland
        • Not yet recruiting
        • Diagnostic and Interventional Radiology, University Hospital Zurich
        • Contact:
        • Principal Investigator:
          • Thomas Frauenfelder
        • Sub-Investigator:
          • Jann Wieler

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Women aged between 45 and 74 years
  • Asymptomatic
  • Signed informed consent form before starting any study activity
  • Average risk of BC (every woman except those with know BRCA1, 2, TP53, and/or previous BC)
  • Mammographic test, either 2D FFDM or 3D Digital Breast Tomosynthesis (DBT) (collecting oblique mediolateral projection [MLO] of the right breast, craniocaudal projection [CC] of the right breast, MLO projection of the left breast, CC projection of the left breast), performed within the past month with available results or planned to be performed in the same day of the MammoWave test or in the subsequent days
  • Spontaneous willingness to comply with CIP and recommendations

Exclusion Criteria:

  • Woman with breast prostheses
  • Women with symptoms or some sign of suspected BC
  • Women with BRCA1, 2, TP53 or previous BC
  • Pregnant women
  • Women who do not have mammographic manifestation of the tumor (known occult breast tumor with only axillar manifestation)
  • Women with breast size larger than the largest MammoWave cup size

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Single Arm

All participants perform:

conventional breast examination path (i.e., screening mammogram, integrated with other radiological/histological output when deemed necessary by the responsible Investigator in each site) AND MammoWave exam.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MammoWave® sensitivity
Time Frame: During the procedure
MammoWave® sensitivity (percentage of 'true positive' results) while using an optimized classification algorithm. The Reference Standard is intended as the output of conventional breast examination path (i.e. screening mammogram, integrated with other radiological/histological output when deemed necessary by the responsible Investigator). Reference Standard may be: BC+ for the histology-confirmed and classified as BI-RADS 1,2 or 3.
During the procedure
MammoWave® specificity
Time Frame: During the procedure
MammoWave® specificity (percentage of 'true negative' results) while using an optimized algorithm.
During the procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Program screening rate
Time Frame: During the baseline
Program screening rate, calculated as the proportion of women diagnosed with BC in the study population
During the baseline
BC detection rates of each by histological type and size of the BC and BI-RADS classification, also by breast density
Time Frame: During the baseline
BC detection rates of each by histological type and size of the BC and BI-RADS classification, also by breast density
During the baseline
MammoWave® sensitivity and specificity after retrospective AI adjustment using the data at the end of the study
Time Frame: During the baseline
Evaluation of the improvement in both sensitivity and specificity when retrospectively using AI algorithms for the evaluation of MammoWave® data after its further optimization with all data collected in the participants included in the study.
During the baseline
Agreement between different evaluator (i.e. local versus central)
Time Frame: During the baseline
Evaluation of the reproducibility of results comparing the lectures performed at the study centers and the centralized lectures
During the baseline
Volunteers' satisfaction questionnaire
Time Frame: During the baseline
Volunteers' satisfaction through a properly designed questionnaire collecting women's issues and plus during the exam with MammoWave® in the language spoken by the women
During the baseline
Detection rates by type of lesion
Time Frame: During the baseline
Evaluation of the detection rates (sensitivity) according to the type of radiological finding (microcalcification, mass, asymmetry or architectural distortion group), also by breast density (according to BI-RADS ACR classification assigned by the radiologist), and comparison with the other standard screening and diagnostic modalities.
During the baseline
Recall rate
Time Frame: During the baseline
Evaluation of MammoWave recalls, also by breast density (according to BI-RADS ACR classification assigned by the radiologist), and comparison with the other standard screening and diagnostic modalities.
During the baseline
Positive-predictive value
Time Frame: During the baseline
Evaluation of MammoWave positive predictive value (for the biopsies performed), also by breast density (according to BI-RADS ACR classification assigned by the radiologist), and comparison with the other standard screening and diagnostic modalities.
During the baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Umbria Bioengineering Technologies

Collaborators

Toscana Life Sciences Sviluppo s.r.l.
London South Bank University
ELAROS 24/7 Limited (UK)
Servicio De Salud De Castilla La Mancha (Spain)
IMT School for Advanced Studies Lucca
EVITA - Cancro Hereditário (Portugal)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2024

Primary Completion (Estimated)

February 15, 2026

Study Completion (Estimated)

December 15, 2026

Study Registration Dates

First Submitted

February 19, 2024

First Submitted That Met QC Criteria

February 26, 2024

First Posted (Actual)

March 4, 2024

Study Record Updates

Last Update Posted (Actual)

May 7, 2024

Last Update Submitted That Met QC Criteria

May 6, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UBT 2023-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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