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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Women's Health: Neoplasm of Breast
- Sponsor
- Umbria Bioengineering Technologies
- Enrollment
- 10000
- Locations
- 9
- Primary Endpoint
- MammoWave® sensitivity
- Status
- Recruiting
- Last Updated
- last year
Overview
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).
Investigators
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
Outcomes
Primary Outcomes
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.
MammoWave® specificity
Time Frame: During the procedure
MammoWave® specificity (percentage of 'true negative' results) while using an optimized algorithm.
Secondary Outcomes
- Agreement between different evaluator (i.e. local versus central)(During the baseline)
- Positive-predictive value(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)
- Detection rates by type of lesion(During the baseline)
- Recall rate(During the baseline)
- Program screening rate(During the baseline)
- MammoWave® sensitivity and specificity after retrospective AI adjustment using the data at the end of the study(During the baseline)
- Volunteers' satisfaction questionnaire(During the baseline)