Trial Title:
A Clinical Investigation to Evaluate Microwave Imaging Via MammoWave® in a Population-based Screening Program for Early Breast Cancer Detection
NCT ID:
NCT06291896
Condition:
Women's Health: Neoplasm of Breast
Conditions: Official terms:
Breast Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Clinical Investigation with class IIa medical device
Primary purpose:
Screening
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
MammoWave
Description:
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.
Arm group label:
Single Arm
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).
Criteria for 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
Gender:
Female
Minimum age:
45 Years
Maximum age:
74 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Ospedale San Giovanni Battista - USL Umbria 2
Address:
City:
Foligno
Zip:
06034
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Riccardo Loretoni
Email:
riccardo.loretoni@uslumbria2.it
Investigator:
Last name:
Riccardo Loretoni
Email:
Principal Investigator
Facility:
Name:
IRCCS Policlinico San Martino
Address:
City:
Genova
Zip:
16132
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Massimo Calabrese
Email:
massimo.calabrese@hsanmartino.it
Investigator:
Last name:
Massimo Calabrese
Email:
Principal Investigator
Investigator:
Last name:
Alberto Stefano Tagliafico
Email:
Sub-Investigator
Facility:
Name:
Pomeranian Medical University Hospital
Address:
City:
Szczecin
Country:
Poland
Status:
Not yet recruiting
Contact:
Last name:
Jan Lubinsky
Email:
jan.lubinski@pum.edu.pl
Investigator:
Last name:
Jan Lubinsky
Email:
Principal Investigator
Facility:
Name:
Champalimaud Foundation
Address:
City:
Lisboa
Country:
Portugal
Status:
Recruiting
Contact:
Last name:
Filipa Lourenço Cardoso
Email:
filipa.cardoso@research.fchampalimaud.org
Investigator:
Last name:
Celeste Alves
Email:
Principal Investigator
Investigator:
Last name:
Maria Antónia Vasconcelos
Email:
Sub-Investigator
Facility:
Name:
Clínica Dr. Passos Ângelo in Lisbon
Address:
City:
Lisboa
Country:
Portugal
Status:
Recruiting
Contact:
Last name:
Ângelo Passos
Email:
epassosangelo@gmail.com
Investigator:
Last name:
Ângelo Passos
Email:
Principal Investigator
Facility:
Name:
Hospital Universitario Reina Sofía- Córdoba
Address:
City:
Córdoba
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Marina Álvarez Benito
Email:
marinaalvarezbenito@telefonica.net
Investigator:
Last name:
Marina Álvarez Benito
Email:
Principal Investigator
Facility:
Name:
Hospital General Universitario Morales Meseguer
Address:
City:
Murcia
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
María Martínez Gálvez
Email:
martinezgalvez@gmail.com
Investigator:
Last name:
María Martínez Gálvez
Email:
Principal Investigator
Investigator:
Last name:
Este Correo
Email:
Sub-Investigator
Facility:
Name:
Complejo Hospitalario Universitario de Toledo
Address:
City:
Toledo
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Daniel Alvarez Sánchez-Bayuela
Email:
danialsanba@gmail.com
Investigator:
Last name:
Cristina Romero Castellano
Email:
Principal Investigator
Facility:
Name:
Diagnostic and Interventional Radiology, University Hospital Zurich
Address:
City:
Zürich
Country:
Switzerland
Status:
Not yet recruiting
Contact:
Last name:
Thomas Frauenfelder
Email:
thomas.frauenfelder@usz.ch
Investigator:
Last name:
Thomas Frauenfelder
Email:
Principal Investigator
Investigator:
Last name:
Jann Wieler
Email:
Sub-Investigator
Start date:
March 15, 2024
Completion date:
December 15, 2026
Lead sponsor:
Agency:
Umbria Bioengineering Technologies
Agency class:
Industry
Collaborator:
Agency:
London South Bank University
Agency class:
Other
Collaborator:
Agency:
ELAROS 24/7 Limited (UK)
Agency class:
Other
Collaborator:
Agency:
Servicio De Salud De Castilla La Mancha (Spain)
Agency class:
Other
Collaborator:
Agency:
IMT School for Advanced Studies Lucca
Agency class:
Other
Collaborator:
Agency:
EVITA - Cancro Hereditário (Portugal)
Agency class:
Other
Collaborator:
Agency:
Fondazione Toscana Life Sciences (Italy)
Agency class:
Other
Source:
Umbria Bioengineering Technologies
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06291896
https://mammoscreenproject.eu/
