Breast CancerDE-17-17NCT04253366
Clinical Investigation to Evaluate the Ability of MammoWave in Breast Lesions Detection
A study testing Clinical investigation device class IIa not marked CE in people with Breast Cancer, run by Umbria Bioengineering Technologies at 3 sites in 2 countries.
Trial summary
This is a multicentric, single arm, prospective, stratified by breast density clinical investigation using Mammowave that is a device, which uses microwaves instead of ionizing radiation (X-ray)for breast lesions(BL) detection. 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 device class IIa not marked CE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 353 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 16 Sep 2020to 20 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 conventional exams (such as breast specialist visit and mammography and/or ultrasound and/or magnetic resonance imaging) within the last month.
- Patients willing to comply with study protocol and recommendations.
- Patients with intact breast skin (i.e. without bleeding lesion, scar).
Who cannot join
- Patients that are enrolled in another clinical study
- Patients who belong to any vulnerable group.
- Patients with implanted electronics.
- Patients who have undergone biopsy less than one week before MammoWave scan
- Patients with breast implants
- Patients with nipple piercings (unless they are removed before MammoWave exam).
- Participation in other studies in the last month before screening
- Pregnancy or breastfeeding
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Italy2 sites
Azienda Ospedaliera Universitaria S. Martino Di Genova
Genova, 16132
Istituto Clinico Humanitas
Rozzano, Milano, 20089
About this study
Official title: A Multicentric, Single Arm, Prospective, Stratified Clinical Investigation to Evaluate the Ability of MammoWave in Breast Lesions Detection
This is a multicentric, single arm, prospective, stratified by breast density clinical investigation using Mammowave that is a device, which uses microwaves instead of ionizing radiation (X-ray)for breast lesions(BL) detection. Specifically, Mammowave employs a novel technique which generates images by processing very low power (<1 mW) microwaves. The exam takes few minutes per breast and is performed with the patient lying in a comfortable 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 number of participants will be 500 (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 healthy volunteers in each centre will be examined by MammoWave. In the second phase, the remaining people will be enrolled (Breast Lesions pts will be about 70% 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.
At the end of the study, in each centre the clinical investigators will compare MammoWave output against the radiologist study output obtained using conventional exams.
In addition, at the end of the study, the MammoWave output will be centrally reviewed in blind by an independent radiologist in order to confirm the data and confirm centrally the comparisons performed locally. The primary goal of the clinical study is to assess Mammowave's ability in BL detection and differentiation.
- Conditions
- Breast Cancer
- Being tested
- Clinical investigation device class IIa not 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 device class IIa not 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 will be ready for the MammoWave exam. The exam will be composed of two phases: the data acquisition and the data processing. During the acquisition that should 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 device class IIa not 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 (against Reference Standard)
MammoWave specificity and sensitivity (against Reference Standard like Mammography, MRI and/or Echography)
Measured: During the baseline
Percentage of correct BL localization in terms of quadrant (against Reference Standard)
Percentage of correct BL localization in terms of quadrant comparing to Reference Standard like Mammography, MRI and/or Echography
Measured: During the baseline
Absolute and rate agreement between different evaluator (i.e. local radiologist versus central)
Absolute and rate agreement between different evaluator local radiologist versus central, in order to avoid mistakes in the MammoWave output.
Measured: Through study completion, an average of 1 year
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 MammoWave test based on 12 questions:
n° 2 "Multiple Choice questions"
YES, NO, explain (with open-ended text area) regarding:
- The effective execution of MammoWave
- The willing to promote MammoWave n° 5 "5 point Numeric Rating scale" ranging from 1 to 5 (1=Not at all, 5= A lot) regarding the subjective evaluation of MammoWave. n° 5 "3 point Numeric Rating scale" ranging from 1 to 3 (1=less, 3= more) regarding the comparative evaluation of MammoWave vs Conventional tests (Mammography, Ultrasound, Magnetic Resonance Imaging).
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 posted5 Feb 2020
- Study start16 Sep 2020
- Primary completion20 Aug 2021
- Study completion20 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- None (open label)
- Enrolment
- 353 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umbria Bioengineering Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04253366
- Sponsor's protocol ID
- DE-17-17
- Acronym
- DE-17-17
- Status last verified
- Aug 2021
- First submitted
- 27 Dec 2019
- Last updated
- 24 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentric, Single Arm, Prospective, Stratified Clinical Investigation to Evaluate the Ability of MammoWave in Breast Lesions Detection
- ClinicalTrials.gov ID
- NCT04253366
- Acronym / sponsor ID
- DE-17-17 / DE-17-17
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 353 participants (actual)
- Lead sponsor
- Umbria Bioengineering TechnologiesIndustry (pharma, biotech, devices)
- Study start
- 16 Sep 2020 (actual)
- Primary completion
- 20 Aug 2021 (actual)
- Study completion
- 20 Aug 2021 (actual)
- First posted
- 5 Feb 2020 (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 using Mammowave that is a device, which uses microwaves instead of ionizing radiation (X-ray)for breast lesions(BL) detection. Specifically, Mammowave employs a novel technique which generates images by processing very low power (<1 mW) microwaves. The exam takes few minutes per breast and is performed with the patient lying in a comfortable 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 number of participants will be 500 (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 healthy volunteers in each centre will be examined by MammoWave. In the second phase, the remaining people will be enrolled (Breast Lesions pts will be about 70% 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.
At the end of the study, in each centre the clinical investigators will compare MammoWave output against the radiologist study output obtained using conventional exams.
In addition, at the end of the study, the MammoWave output will be centrally reviewed in blind by an independent radiologist in order to confirm the data and confirm centrally the comparisons performed locally. The primary goal of the clinical study is to assess Mammowave's ability in BL detection and differentiation.
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
| Arm | Type | Receives |
|---|---|---|
| Single arm | Other | Device: Clinical investigation device class IIa not 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 (6 listed)
- Signed Informed consent Form
- Women
- Adult ≥18 years old
- Having a radiologist study output obtained using conventional exams (such as breast specialist visit and mammography and/or ultrasound and/or magnetic resonance imaging) within the last month.
- Patients willing to comply with study protocol and recommendations.
Key exclusion criteria (8 listed)
- Patients that are enrolled in another clinical study
- Patients who belong to any vulnerable group.
- Patients with implanted electronics.
- Patients who have undergone biopsy less than one week before MammoWave scan
- Patients with breast implants
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 device class IIa not 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 will be ready for the MammoWave exam. The exam will be composed of two phases: the data acquisition and the data processing. During the acquisition that should 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 (against Reference Standard)
Time frame: During the baseline
Percentage of correct BL localization in terms of quadrant (against Reference Standard)
Time frame: During the baseline
Absolute and rate agreement between different evaluator (i.e. local radiologist versus central)
Time frame: Through study completion, an average of 1 year
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2021.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 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 device class IIa not marked CE in people with Breast Cancer, run by Umbria Bioengineering Technologies at 3 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 6 inclusion and 8 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: finished, as of the sponsor's last update on 24 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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?
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 24 Aug 2021.