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

Overview

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

• Device 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 shou

Primary outcome measures

• MammoWave® sensitivity [Time frame: During the procedure]
• MammoWave® specificity [Time frame: During the procedure]

Secondary outcome measures (8)

• Detection rates by type of lesion [Time frame: During the baseline]
• Recall rate [Time frame: During the baseline]
• Positive-predictive value [Time frame: During the baseline]
• Program screening rate [Time frame: During the baseline]
• BC detection rates of each by histological type and size of the BC and BI-RADS classification, also by breast density [Time frame: During the baseline]
• MammoWave® sensitivity and specificity after retrospective AI adjustment using the data at the end of the study [Time frame: During the baseline]
• Agreement between different evaluator (i.e. local versus central) [Time frame: During the baseline]
• Volunteers' satisfaction questionnaire [Time frame: During the baseline]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Screening

Study locations

Italy · 3 centers

• IRCCS Policlinico San Martino — Genova
• Ospedale San Giovanni Battista - USL Umbria 2 — Foligno
• Az. San. Univ. Giuliano Isontina (ASU GI) — Trieste

Spain · 3 centers

• Hospital Universitario Reina Sofía- Córdoba — Córdoba
• Hospital General Universitario Morales Meseguer — Murcia
• Complejo Hospitalario Universitario de Toledo — Toledo

Portugal · 2 centers

• Champalimaud Foundation — Lisbon
• Clínica Dr. Passos Ângelo in Lisbon — Lisbon

Poland · 1 center

• Pomeranian Medical University Hospital — Szczecin

Switzerland · 1 center

• Diagnostic and Interventional Radiology, University Hospital Zurich — Zurich

Publications

• 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 investigati PMID 39488412

Identifiers

NCT: NCT06291896 · UBT 2023-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗