Women's Health: Neoplasm of BreastNCT06291896
A Clinical Investigation to Evaluate Microwave Imaging Via MammoWave® in a Population-based Screening Program for Early Breast Cancer Detection
A study testing MammoWave in people with Women's Health: Neoplasm of Breast, run by Umbria Bioengineering Technologies at 10 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 74 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Women's Health: Neoplasm of Breast
- What is being tested?
- MammoWave
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,000 participants
- Where
- 10 sitesin 5 countries
- Study dates
- 15 Mar 2024to 15 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 74 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
10 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
Sabatino Tiberi contact
10 sites in 5 countries
Italy3 sites, 3 recruiting
- Recruiting
Ospedale San Giovanni Battista - USL Umbria 2
Foligno, Perugia, 06034
Riccardo Loretoni, riccardo.loretoni@uslumbria2.it
Riccardo Loretoni
- Recruiting
IRCCS Policlinico San Martino
Genova, Genova, 16132
Massimo Calabrese, massimo.calabrese@hsanmartino.it
Massimo Calabrese
- Recruiting
Az. San. Univ. Giuliano Isontina (ASU GI)
Trieste, 34128
Maura Tonutti, maura.tonutti@asugi.sanita.fvg.it
Maura Tonutti
Spain3 sites, 3 recruiting
- Recruiting
Hospital Universitario Reina Sofía- Córdoba
Córdoba
Marina Álvarez Benito, marinaalvarezbenito@telefonica.net
Marina Álvarez Benito
- Recruiting
Hospital General Universitario Morales Meseguer
Murcia
María Martínez Gálvez, martinezgalvez@gmail.com
María Martínez Gálvez
- Recruiting
Complejo Hospitalario Universitario de Toledo
Toledo
Daniel Alvarez Sánchez-Bayuela, danialsanba@gmail.com
Cristina Romero Castellano
Portugal2 sites, 2 recruiting
- Recruiting
Champalimaud Foundation
Lisbon
Filipa Lourenço Cardoso, filipa.cardoso@research.fchampalimaud.org
Celeste Alves
- Recruiting
Clínica Dr. Passos Ângelo in Lisbon
Lisbon
Ângelo Passos, epassosangelo@gmail.com
Ângelo Passos
Poland1 site, 1 recruiting
- Recruiting
Pomeranian Medical University Hospital
Szczecin
Jan Lubinsky, jan.lubinski@pum.edu.pl
Jan Lubinsky
Switzerland1 site, 1 recruiting
- Recruiting
Diagnostic and Interventional Radiology, University Hospital Zurich
Zurich
Thomas Frauenfelder, thomas.frauenfelder@usz.ch
Thomas Frauenfelder
About this study
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
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.
Read the 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).
- Conditions
- Women's Health: Neoplasm of Breast
- Being tested
- MammoWave
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MammoWaveDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Other | All participants perform:
conventional breast examination path (i.e., screening mammogram, integrated with other radiological/histological output when deemed necessary by the responsible Investigator in each site) AND MammoWave exam. Receives: Device: MammoWave |
What is being measured
The primary outcome is the main question the study is designed to answer.
MammoWave® sensitivity
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.
Measured: During the procedure
MammoWave® specificity
MammoWave® specificity (percentage of 'true negative' results) while using an optimized algorithm.
Measured: During the procedure
Secondary outcomes (8)
Detection rates by type of lesion
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.
Measured: During the baseline
Recall rate
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.
Measured: During the baseline
Positive-predictive value
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.
Measured: During the baseline
Program screening rate
Program screening rate, calculated as the proportion of women diagnosed with BC in the study population
Measured: During the baseline
BC detection rates of each by histological type and size of the BC and BI-RADS classification, also by breast density
BC detection rates of each by histological type and size of the BC and BI-RADS classification, also by breast density
Measured: During the baseline
MammoWave® sensitivity and specificity after retrospective AI adjustment using the data at the end of the study
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.
Measured: During the baseline
Agreement between different evaluator (i.e. local versus central)
Evaluation of the reproducibility of results comparing the lectures performed at the study centers and the centralized lectures
Measured: During the baseline
Volunteers' satisfaction questionnaire
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
Measured: During the baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start15 Mar 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Women's Health: Neoplasm of BreastStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Clinical Investigation with class IIa medical device
- Masking
- None (open label)
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Umbria Bioengineering Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- 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)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06291896
- Sponsor's protocol ID
- UBT 2023-01
- Status last verified
- May 2026
- First submitted
- 19 Feb 2024
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 investigation to evaluate cancer detection capabilities of MammoWave system on an asymptomatic population across multiple European countries. BMJ Open. 2024 Nov 2;14(11):e088431. doi: 10.1136/bmjopen-2024-088431.
PubMed 39488412
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06291896
- Acronym / sponsor ID
- UBT 2023-01
- Conditions
- Women's Health: Neoplasm of Breast
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Umbria Bioengineering TechnologiesIndustry (pharma, biotech, devices)
- Collaborators
- 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 start
- 15 Mar 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 4 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Clinical Investigation with class IIa medical device
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Other | Device: MammoWaveAll participants perform: conventional breast examination path (i.e., screening mammogram, integrated with other radiological/histological output when deemed necessary by the responsible Investigator in each site) AND MammoWave exam. |
Who may qualify
- Ages
- 45 to 74 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MammoWaveWomen 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. | Device | Single Arm |
Primary outcome
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.
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Derived from this study: PubMed 39488412Alvarez 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 investigation to evaluate cancer detection capabilities of MammoWave system on an asymptomatic population across multiple European countries. BMJ Open. 2024 Nov 2;14(11):e088431. doi: 10.1136/bmjopen-2024-088431.
- \[1\]Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sabatino Tiberi contact
10 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MammoWave in people with Women's Health: Neoplasm of Breast, run by Umbria Bioengineering Technologies at 10 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Italy, Spain, Portugal, Poland, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gianluigi Tiberi (0039 3490564302, gianluigi@ubt-tech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MammoWave® sensitivity (time frame: During the procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06291896, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.