Women's Health: Neoplasm of Breast
Conditions
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).
Interventions
DEVICEMammoWave
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.
Sponsors
Umbria Bioengineering Technologies
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)
Fondazione Toscana Life Sciences (Italy)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Intervention model description
Clinical Investigation with class IIa medical device
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 74 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MammoWave® sensitivity | 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 | During the procedure | MammoWave® specificity (percentage of 'true negative' results) while using an optimized algorithm. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Detection rates by type of lesion | 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. |
| Recall rate | 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. |
| Positive-predictive value | 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. |
| Program screening rate | During the baseline | Program screening rate, calculated as the proportion of women diagnosed with BC in the study population |
| BC detection rates of each by histological type and size of the BC and BI-RADS classification, also by breast density | During the baseline | BC detection rates of each by histological type and size of the BC and BI-RADS classification, also by breast density |
| MammoWave® sensitivity and specificity after retrospective AI adjustment using the data at the end of the study | 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. |
| Agreement between different evaluator (i.e. local versus central) | During the baseline | Evaluation of the reproducibility of results comparing the lectures performed at the study centers and the centralized lectures |
| Volunteers' satisfaction questionnaire | 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 |
Countries
Italy, Poland, Portugal, Spain, Switzerland
Contacts
CONTACTGianluigi Tiberi
CONTACTSabatino Tiberi
Outcome results
None listed