A Clinical Investigation to Evaluate Microwave Imaging Via MammoWave® in a Population-based Screening Program for Early Breast Cancer Detection
NCT ID: NCT06291896
Last Updated: 2025-01-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
10000 participants
INTERVENTIONAL
2024-03-15
2026-12-15
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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NA
SINGLE_GROUP
SCREENING
NONE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
45 Years
74 Years
FEMALE
Yes
Sponsors
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London South Bank University
OTHER
ELAROS 24/7 Limited (UK)
UNKNOWN
Servicio De Salud De Castilla La Mancha (Spain)
UNKNOWN
IMT School for Advanced Studies Lucca
OTHER
EVITA - Cancro Hereditário (Portugal)
UNKNOWN
Fondazione Toscana Life Sciences (Italy)
UNKNOWN
Umbria Bioengineering Technologies
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Related Links
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Other Identifiers
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UBT 2023-01
Identifier Type: -
Identifier Source: org_study_id
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