Breast CancerNCT05300464
A Clinical Investigation to Confirm the Ability of MammoWave in Breast Lesions Detection
A study testing Clinical investigation medical device class IIa marked CE in people with Breast Cancer, run by Umbria Bioengineering Technologies at 4 sites in 2 countries.
Trial summary
This is a multicentric, single arm, prospective, stratified by breast density clinical investigation to confirm the ability of the microwave mammogram 'MammoWave' to detect breast lesions. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Clinical investigation medical device class IIa marked CE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 7 Jan 2023to 31 Jan 2027
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed Informed consent Form
- Women
- Adult ≥ 18 years old
- Having a radiologist study output obtained using mammography within the last month. Such radiologist study output may be integrated with ultrasound and /or magnetic resonance imaging output if deemed necessary by the responsible investigator and when available. The radiological output will be integrated with histological one if deemed necessary by the responsible investigator and when available.
- Patients willing to comply with study protocol and recommendations
Who cannot join
- Patients who belong to any vulnerable group
- Patients with implanted electronic devices
- Patients who have undergone biopsy less than one week before MammoWave scan
- Patients with nipple piercings (unless they are removed prior to examination)
- Pregnancy or breastfeeding
Trial locations and contacts
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Sabatino Tiberi contact
4 sites in 2 countries
Italy3 sites, 3 recruiting
- Recruiting
Ospedale San Giovanni Battista - USL Umbria 2
Foligno, Perugia, 06034
Riccardo LORETONI, 0742/3397116
- Recruiting
IRCCS Policlinico San Martino
Genova, Genova, 16132
Alberto TAGLIAFICO, 010/555 3067, alberto.tagliafico@unige.it
- Recruiting
Az. San. Univ. Giuliano Isontina (ASU GI)
Trieste, 34128
Maura Tonutti, maura.tonutti@asugi.sanita.fvg.it
Maura Tonutti
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario de Toledo
Toledo, Spain, 45007
Cristina ROMERO CASTELLANO, cromeroc@gmail.com
About this study
Official title: A Clinical Investigation (Multicentric, Single Arm, Prospective, Stratified) to Confirm the Ability of MammoWave (Microwave Mammogram) in Breast Lesions Detection
This is a multicentric, single arm, prospective, stratified by breast density clinical investigation to confirm the ability of the microwave mammogram 'MammoWave' to detect breast lesions.
MammoWave is a innovative medical device, class IIa marked CE, which uses microwaves instead of ionazing radiation (x-ray) for breast lesions. Specifically MammoWave employs a novel technique wich generates images by processing very low power (<1mW) microwave.
The MammoWave exam takes few minutes for breast and is performed with the patient lying in a confortable facing down position.
MammoWave is safe to be used at any age, in any condition (pregnancy, specific illness and for unlimited number of times.
Read the detailed description
The maximum number of participants to the clinical investigation will be 600 (for all the sites). The study will be composed of two phases: a preliminary phase to 'optimize the imaging algorithm for each apparatus installed at each centre', where 15 volunteers (in each centre) having breast with no lesions (NL) will be examined by MammoWave. In the second phase, the remaining people will be enrolled (BL will be 50% of total) and examined by MammoWave by the clinical investigator, and results will be compared with the effective diagnosis already obtained by standard clinical methods. BL includes malignant lesions (BC) and benign lesions, and may be palpable or non-palpable lesions. BL includes also isolated clustered microcalcifications.
The primary gol of the clinical study is to assess MammoWave's ability in BL detection.
The study will involve investigational sites in Italy, Germany and Spain.
- Conditions
- Breast Cancer
- Being tested
- Clinical investigation medical device class IIa marked CE
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical investigation medical device class IIa marked CEDevice
Patients should perform MammoWave exam. A short visit should be performed and during this visit a qualitative differentiation would be performed between patients with high density breast, and patients with low density breast. After the patients are ready for MammoWave exam. The exam will composed of two phases: the acquisition and data processing. During the acquisition that sholud takes about 10 minutes the patients would be lying in a prone position, on a bed which is part of the MammoWave. The upper part of MammoWave has a container cup shape, which contains the breast, which also has the function of separate it from the internal parts of the device. After patient is on the bed and MammoWave would start to perform the acquisition. Once the acquisition is completed, the data will be processed through an imaging algorithm, which is integrated in the device. The final output will be composed by one or more images, plus one or more parameters describing the images.
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Other | All patients perform standard breast screening and also MammoWave exam. Receives: Device: Clinical investigation medical device class IIa marked CE |
What is being measured
The primary outcome is the main question the study is designed to answer.
MammoWave sensitivity (number of 'true positive' results)
MammoWave sensitivity (number of 'true positive' results) compared to Reference Standard
Measured: During the procedure
Secondary outcomes (6)
MammoWave specificity and sensitivity
MammoWave specificity and sensitivity (against Reference Standard)
Measured: During the baseline
Sensitivity for each breast density group
Sensitivity of MammoWave according to different types of breast density groups
Measured: During the baseline
Sensitivity for patients which had recent mammography
Sensitivity for patients which had performed recently mammography exam
Measured: During the baseline
Patient satisfaction questionnaire
Patient satisfaction questionnaire output according to their experience performing
Measured: During the baseline
MammoWave sensitivity in BC
Sensitivity of MammoWave in Breast Cancer detection (against reference standard)
Measured: During the baseline)
MammoWave specificity and sensitivity using RadioSpin simulator
Specificity and sensitivity of MammoWave (against Reference Standard) when retrospectively using MammoWave data in one RadioSpin technology simulator / Artificial Intelligence (AI) algorithms. NOTE: RadioSpin (Deep oscillatory neural networks computing and learning through the dynamics of RF neurons interconnected by RF spintronic synapses) is one of the projects funded by EU within the call FUTURE EMERGING TECHNOLOGIES (FET) H2020-FETPROACT. The RadioSpin project aims to build a hardware neural network, as a "Hardware Artificial Intelligence" will be implemented. During the project, these hardware neural networks will be optimized and tested on MammoWave data, being UBT partner of RadioSpin consortium (Grant agreement ID: 101017098)
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 posted29 Mar 2022
- Study start7 Jan 2023
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Jan 2027 (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 Breast CancerStudies 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 Medical Device class IIa marked CE
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Umbria Bioengineering Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05300464
- Sponsor's protocol ID
- UBT 2022-01
- Status last verified
- May 2026
- First submitted
- 18 Mar 2022
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alvarez Sanchez-Bayuela D, Ghavami N, Romero Castellano C, Bigotti A, Badia M, Papini L, Raspa G, Palomba G, Ghavami M, Loretoni R, Calabrese M, Tagliafico A, Tiberi G. A Multicentric, Single Arm, Prospective, Stratified Clinical Investigation to Confirm MammoWave's Ability in Breast Lesions Detection. Diagnostics (Basel). 2023 Jun 17;13(12):2100. doi: 10.3390/diagnostics13122100.
PubMed 37370995
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Investigation (Multicentric, Single Arm, Prospective, Stratified) to Confirm the Ability of MammoWave (Microwave Mammogram) in Breast Lesions Detection
- ClinicalTrials.gov ID
- NCT05300464
- Acronym / sponsor ID
- UBT 2022-01
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Umbria Bioengineering TechnologiesIndustry (pharma, biotech, devices)
- Study start
- 7 Jan 2023 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 29 Mar 2022 (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 a multicentric, single arm, prospective, stratified by breast density clinical investigation to confirm the ability of the microwave mammogram 'MammoWave' to detect breast lesions.
MammoWave is a innovative medical device, class IIa marked CE, which uses microwaves instead of ionazing radiation (x-ray) for breast lesions. Specifically MammoWave employs a novel technique wich generates images by processing very low power (<1mW) microwave.
The MammoWave exam takes few minutes for breast and is performed with the patient lying in a confortable facing down position.
MammoWave is safe to be used at any age, in any condition (pregnancy, specific illness and for unlimited number of times.
Detailed description
The maximum number of participants to the clinical investigation will be 600 (for all the sites). The study will be composed of two phases: a preliminary phase to 'optimize the imaging algorithm for each apparatus installed at each centre', where 15 volunteers (in each centre) having breast with no lesions (NL) will be examined by MammoWave. In the second phase, the remaining people will be enrolled (BL will be 50% of total) and examined by MammoWave by the clinical investigator, and results will be compared with the effective diagnosis already obtained by standard clinical methods. BL includes malignant lesions (BC) and benign lesions, and may be palpable or non-palpable lesions. BL includes also isolated clustered microcalcifications.
The primary gol of the clinical study is to assess MammoWave's ability in BL detection.
The study will involve investigational sites in Italy, Germany and Spain.
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 Medical Device class IIa marked CE
| Arm | Type | Receives |
|---|---|---|
| Single arm | Other | Device: Clinical investigation medical device class IIa marked CEAll patients perform standard breast screening and also MammoWave exam. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Signed Informed consent Form
- Women
- Adult ≥ 18 years old
- Having a radiologist study output obtained using mammography within the last month. Such radiologist study output may be integrated with ultrasound and /or magnetic resonance imaging output if deemed necessary by the responsible investigator and when available. The radiological output will be integrated with histological one if deemed necessary by the responsible investigator and when available.
- Patients willing to comply with study protocol and recommendations
Key exclusion criteria (5 listed)
- Patients who belong to any vulnerable group
- Patients with implanted electronic devices
- Patients who have undergone biopsy less than one week before MammoWave scan
- Patients with nipple piercings (unless they are removed prior to examination)
- Pregnancy or breastfeeding
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 |
|---|---|---|
| Clinical investigation medical device class IIa marked CEPatients should perform MammoWave exam. A short visit should be performed and during this visit a qualitative differentiation would be performed between patients with high density breast, and patients with low density breast. After the patients are ready for MammoWave exam. The exam will composed of two phases: the acquisition and data processing. During the acquisition that sholud takes about 10 minutes the patients would be lying in a prone position, on a bed which is part of the MammoWave. The upper part of MammoWave has a container cup shape, which contains the breast, which also has the function of separate it from the internal parts of the device. After patient is on the bed and MammoWave would start to perform the acquisition. Once the acquisition is completed, the data will be processed through an imaging algorithm, which is integrated in the device. The final output will be composed by one or more images, plus one or more parameters describing the images. | Device | Single arm |
Primary outcome
MammoWave sensitivity (number of 'true positive' results)
Time frame: During the procedure
MammoWave sensitivity (number of 'true positive' results) compared to Reference Standard
6 secondary outcomes
MammoWave specificity and sensitivity
Time frame: During the baseline
Sensitivity for each breast density group
Time frame: During the baseline
Sensitivity for patients which had recent mammography
Time frame: During the baseline
Patient satisfaction questionnaire
Time frame: During the baseline
MammoWave sensitivity in BC
Time frame: During the baseline)
MammoWave specificity and sensitivity using RadioSpin simulator
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 15 May 2026.
- Derived from this study: PubMed 37370995Alvarez Sanchez-Bayuela D, Ghavami N, Romero Castellano C, Bigotti A, Badia M, Papini L, Raspa G, Palomba G, Ghavami M, Loretoni R, Calabrese M, Tagliafico A, Tiberi G. A Multicentric, Single Arm, Prospective, Stratified Clinical Investigation to Confirm MammoWave's Ability in Breast Lesions Detection. Diagnostics (Basel). 2023 Jun 17;13(12):2100. doi: 10.3390/diagnostics13122100.
- Individual participant dataSharing planned: No
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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
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical investigation medical device class IIa marked CE in people with Breast Cancer, run by Umbria Bioengineering Technologies at 4 sites in 2 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 5 inclusion and 5 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 15 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 4 sites in Italy, Spain. 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 34900564302, 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 (number of 'true positive' results) (time frame: During the procedure). 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 NCT05300464, 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 15 May 2026.