Clinical trial NCT06291896: A Clinical Investigation to Evaluate Microwave Imaging Via MammoWave® in a Population-based Screening Program for Early Breast Cancer Detection
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Women's Health: Neoplasm of Breast
Lead sponsor: Umbria Bioengineering Technologies
Sponsor class: INDUSTRY
Collaborators: name: London South Bank University
name: ELAROS 24/7 Limited (UK)
name: Servicio De Salud De Castilla La Mancha (Spain)
name: IMT School for Advanced Studies Lucca
name: EVITA - Cancro Hereditário (Portugal)
name: Fondazione Toscana Life Sciences (Italy)
First posted: 2024-03-04
Enrollment: 10000
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Clinical Investigation with class IIa medical device
Primary purpose: SCREENING

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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: MammoWave® sensitivity
timeFrame: During the procedure
measure: MammoWave® specificity
timeFrame: During the procedure
Secondary outcomes:
measure: Detection rates by type of lesion
timeFrame: During the baseline
measure: Recall rate
timeFrame: During the baseline
measure: Positive-predictive value
timeFrame: During the baseline
measure: Program screening rate
timeFrame: During the baseline
measure: BC detection rates of each by histological type and size of the BC and BI-RADS classification, also by breast density
timeFrame: During the baseline
measure: MammoWave® sensitivity and specificity after retrospective AI adjustment using the data at the end of the study
timeFrame: During the baseline
measure: Agreement between different evaluator (i.e. local versus central)
timeFrame: During the baseline
measure: Volunteers' satisfaction questionnaire
timeFrame: During the baseline
Other outcomes:
Locations:
city: Foligno
country: Italy
facility: Ospedale San Giovanni Battista - USL Umbria 2
state: Perugia
city: Genova
country: Italy
facility: IRCCS Policlinico San Martino
city: Szczecin
country: Poland
facility: Pomeranian Medical University Hospital
city: Lisboa
country: Portugal
facility: Champalimaud Foundation
city: Lisboa
country: Portugal
facility: Clínica Dr. Passos Ângelo in Lisbon
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofía- Córdoba
city: Murcia
country: Spain
facility: Hospital General Universitario Morales Meseguer
city: Toledo
country: Spain
facility: Complejo Hospitalario Universitario de Toledo
city: Zürich
country: Switzerland
facility: Diagnostic and Interventional Radiology, University Hospital Zurich
Study officials:
References: