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

NCT06291896 | Recruiting

• 1 other identifier: UBT 2023-01
• Study Type: interventional
• Target: 10,000
• Locations: 5 countries
• Sites: 9

Brief 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

Outcome Measures

Primary Outcomes (2)

• MammoWave® sensitivity

  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

  MammoWave® specificity (percentage of 'true negative' results) while using an optimized algorithm.

  During the procedure

Secondary Outcomes (8)

• Detection rates by type of lesion

  During the baseline

• Recall rate

  During the baseline

• Positive-predictive value

  During the baseline

• Program screening rate

  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

Study Arms (1)

Single Arm

OTHER

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

Interventions

MammoWave DEVICE

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.

Single Arm

Eligibility Criteria

• Age: 45 Years - 74 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Umbria Bioengineering Technologies: lead
• London South Bank University: collaborator
• ELAROS 24/7 Limited (UK): collaborator
• Servicio De Salud De Castilla La Mancha (Spain): collaborator
• IMT School for Advanced Studies Lucca: collaborator
• EVITA - Cancro Hereditário (Portugal): collaborator
• Fondazione Toscana Life Sciences (Italy): collaborator

Study Sites (9)

Ospedale San Giovanni Battista - USL Umbria 2

Foligno, Perugia, 06034, Italy

RECRUITING

IRCCS Policlinico San Martino

Genova, 16132, Italy

RECRUITING

Pomeranian Medical University Hospital

Szczecin, Poland

RECRUITING

Champalimaud Foundation

Lisbon, Portugal

RECRUITING

Clínica Dr. Passos Ângelo in Lisbon

Lisbon, Portugal

RECRUITING

Hospital Universitario Reina Sofía- Córdoba

Córdoba, Spain

RECRUITING

Hospital General Universitario Morales Meseguer

Murcia, Spain

NOT YET RECRUITING

Complejo Hospitalario Universitario de Toledo

Toledo, Spain

RECRUITING

Diagnostic and Interventional Radiology, University Hospital Zurich

Zurich, Switzerland

RECRUITING

Related Publications (1)

• Alvarez Sanchez-Bayuela D, Fernandez Martin J, Tiberi G, Ghavami N, Giovanetti Gonzalez R, Cruz Hernanez LM, Aguilar Angulo PM, Martinez Gomez AD, Rodriguez Sanchez A, Bigotti A, Khalesi B, Pontoriero L, Calabrese M, Tagliafico AS, Romero Castellano C. Microwave imaging for breast cancer screening: protocol for an open, multicentric, interventional, prospective, non-randomised clinical investigation to evaluate cancer detection capabilities of MammoWave system on an asymptomatic population across multiple European countries. BMJ Open. 2024 Nov 2;14(11):e088431. doi: 10.1136/bmjopen-2024-088431.

  PMID: 39488412 DERIVED

Related Links

• \[1\]

Central Study Contacts

Gianluigi Tiberi

CONTACT

0039 3490564302; gianluigi@ubt-tech.com

Sabatino Tiberi

CONTACT

s.tiberi@ubt-tech.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Clinical Investigation with class IIa medical device

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: March 4, 2024
• Study Start: March 15, 2024
• Primary Completion: February 15, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: January 6, 2025

Record last verified: 2025-01

Locations

CH (1); PL (1); IT (2); PT (2); ES (3)