Breast CancerNCT05757427
Pilot Clinical Evaluation of a Microwave Imaging System for Breast Cancer Detection
A study testing Wavelia #2 in people with Breast Cancer, run by MVG Industries SAS at 1 site in Ireland.
Trial summary
The trialed investigational medical imaging device is a low-power microwave breast imaging system for cancer screening purposes. It is an active device which uses non-ionizing radiation. Microwave imaging is an emerging imaging modality for the early detection of breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Wavelia #2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteIreland
- Study dates
- 9 Mar 2023to 4 Oct 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed Consent
- Female subjects with an investigator assessed discrete breast abnormality of size > 1cm
- Able and willing to comply with the requirements of this study protocol
- Negative urine pregnancy test on the day of microwave imaging procedure (if of childbearing potential)
- intact breast skin (i.e., without bleeding lesion, no evidence of inflammation and/or erythema of the breast)
- Able to comfortably lie reasonably still in a prone position for approximately 15 minutes
- Have had biopsy more than 2 weeks prior to the microwave breast investigation (if applicable)
Who cannot join
- Have a cup size of A or whose breast is deemed too small to allow MBI assessment in the opinion of the investigator
- Are pregnant or breast-feeding
- Have had surgery on either breast within the past 12 months
- Have any active or metallic implant other than a biopsy clip
- Would be unsuitable for an MBI scan or unlikely to follow the protocol in the opinion of the Investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-label,Single Site,Pilot Clinical Investigation to Assess Detectability and Sizing of Invasive Breast Cancers,Detectability of Benign Breast Lesions,Differentiation Between Malignant and Benign Breast Lesions Using Wavelia # 2
The trialed investigational medical imaging device is a low-power microwave breast imaging system for cancer screening purposes. It is an active device which uses non-ionizing radiation.
Microwave imaging is an emerging imaging modality for the early detection of breast cancer. The physical basis of microwave imaging is the dielectric contrast between healthy and cancerous breast tissues at the microwave frequency spectrum.
This study is a pilot Clinical Evaluation of a microwave imaging system (Wavelia #2) for Breast Cancer Detection. The clinical data that will be collected in the context of this study is intended for the assessment of the imaging diagnostic capability and the safety of the investigational device.
Read the detailed description
This study aims to enrol approximately 103 subjects presenting to the symptomatic breast unit with a breast abnormality who consent to undergo an Microwave Breast Imaging (MWBI) scan using the Wavelia #2 imaging system. The study uses an adaptive design to verify and validate the technical evolutions that have been integrated in the Wavelia# 2 prototype on a small patient dataset (30 patients). Once the technical performance has been established recruitment will continue to assess the clinical performance of the MBI system compared to standard of care reference imaging. The primary objectives of the study are to assess the performance of Wavelia # 2 in the detection of malignant and benign breast lesions, the sizing of malignant lesions for which post-surgery histology data will be available and the differentiation between benign and malignant breast abnormalities by means of features extracted from the MBI images.
- Conditions
- Breast Cancer
- Being tested
- Wavelia #2
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wavelia #2Device
Patients who are eligible and consent to have an MBI breast scan procedure will be asked to confirm their willingness to participate on the day of the breast scan. The patient will first have an Optical Breast Contour Detection (OBCD) scan, to reconstruct the external surface of the breast with high-precision, measure the total volume and the vertical extent of the breast before the MBI scan. The MBI scan will be performed on both breasts. The process will include optimization of breast positioning and breast cleaning to remove any transition liquid remaining on the skin.
| Study group | Role | What they receive |
|---|---|---|
| All patients will have an MBI scan with Wavelia #2 in addition to standard reference imaging. | Experimental | Patients with an investigator assessed discrete breast abnormality of size >1cm and who attend the symptomatic breast unit for assessment as per standard of care protocol will be considered for participation in this clinical investigation. Receives: Device: Wavelia #2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the Detectability Rate of Malignant and Benign Breast Lesions.
Endpoint: Percentage of malignant and benign breast lesions correctly detected with Wavelia MWBI
Measured: 21 days
Secondary outcomes (1)
Correct Sizing of Breast Lesions With Wavelia MWBI
Endpoint: Maximal linear size difference (in mm) between the MWBI lesion detection and the maximal size reported in the ultrasound lesion size estimates. This is measured as a continuous variable of difference in mm
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2023
- Study start9 Mar 2023
- Primary completion13 Jun 2024
- Study completion4 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All patients will have an MBI scan with Wavelia in addition to standard of care procedures
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- MVG Industries SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Kerin, Principal investigator, Galway University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05757427
- Sponsor's protocol ID
- TP.102.17.22.PAR
- Status last verified
- Oct 2025
- First submitted
- 23 Feb 2023
- Last updated
- 26 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- 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 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label,Single Site,Pilot Clinical Investigation to Assess Detectability and Sizing of Invasive Breast Cancers,Detectability of Benign Breast Lesions,Differentiation Between Malignant and Benign Breast Lesions Using Wavelia # 2
- ClinicalTrials.gov ID
- NCT05757427
- Acronym / sponsor ID
- TP.102.17.22.PAR
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- MVG Industries SASIndustry (pharma, biotech, devices)
- Study start
- 9 Mar 2023 (actual)
- Primary completion
- 13 Jun 2024 (actual)
- Study completion
- 4 Oct 2024 (actual)
- First posted
- 7 Mar 2023 (actual)
- Results
- Posted 26 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The trialed investigational medical imaging device is a low-power microwave breast imaging system for cancer screening purposes. It is an active device which uses non-ionizing radiation.
Microwave imaging is an emerging imaging modality for the early detection of breast cancer. The physical basis of microwave imaging is the dielectric contrast between healthy and cancerous breast tissues at the microwave frequency spectrum.
This study is a pilot Clinical Evaluation of a microwave imaging system (Wavelia #2) for Breast Cancer Detection. The clinical data that will be collected in the context of this study is intended for the assessment of the imaging diagnostic capability and the safety of the investigational device.
Detailed description
This study aims to enrol approximately 103 subjects presenting to the symptomatic breast unit with a breast abnormality who consent to undergo an Microwave Breast Imaging (MWBI) scan using the Wavelia #2 imaging system. The study uses an adaptive design to verify and validate the technical evolutions that have been integrated in the Wavelia# 2 prototype on a small patient dataset (30 patients). Once the technical performance has been established recruitment will continue to assess the clinical performance of the MBI system compared to standard of care reference imaging. The primary objectives of the study are to assess the performance of Wavelia # 2 in the detection of malignant and benign breast lesions, the sizing of malignant lesions for which post-surgery histology data will be available and the differentiation between benign and malignant breast abnormalities by means of features extracted from the MBI images.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All patients will have an MBI scan with Wavelia in addition to standard of care procedures
| Arm | Type | Receives |
|---|---|---|
| All patients will have an MBI scan with Wavelia #2 in addition to standard reference imaging. | Experimental | Device: Wavelia #2Patients with an investigator assessed discrete breast abnormality of size >1cm and who attend the symptomatic breast unit for assessment as per standard of care protocol will be considered for participation in this clinical investigation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Informed Consent
- Female subjects with an investigator assessed discrete breast abnormality of size > 1cm
- Able and willing to comply with the requirements of this study protocol
- Negative urine pregnancy test on the day of microwave imaging procedure (if of childbearing potential)
- intact breast skin (i.e., without bleeding lesion, no evidence of inflammation and/or erythema of the breast)
Key exclusion criteria (5 listed)
- Have a cup size of A or whose breast is deemed too small to allow MBI assessment in the opinion of the investigator
- Are pregnant or breast-feeding
- Have had surgery on either breast within the past 12 months
- Have any active or metallic implant other than a biopsy clip
- Would be unsuitable for an MBI scan or unlikely to follow the protocol in the opinion of the Investigator
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 |
|---|---|---|
| Wavelia #2Patients who are eligible and consent to have an MBI breast scan procedure will be asked to confirm their willingness to participate on the day of the breast scan. The patient will first have an Optical Breast Contour Detection (OBCD) scan, to reconstruct the external surface of the breast with high-precision, measure the total volume and the vertical extent of the breast before the MBI scan. The MBI scan will be performed on both breasts. The process will include optimization of breast positioning and breast cleaning to remove any transition liquid remaining on the skin. | Device | All patients will have an MBI scan with Wavelia #2 in addition to standard reference imaging. |
Primary outcome
Assess the Detectability Rate of Malignant and Benign Breast Lesions.
Time frame: 21 days
Endpoint: Percentage of malignant and benign breast lesions correctly detected with Wavelia MWBI
1 secondary outcome
Correct Sizing of Breast Lesions With Wavelia MWBI
Time frame: 21 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Michael Kerin principal investigator
Galway University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wavelia #2 in people with Breast Cancer, run by MVG Industries SAS at 1 site in Ireland.
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 7 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: finished, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. 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?
Yes. Results are posted in the registry (first posted 26 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Assess the Detectability Rate of Malignant and Benign Breast Lesions. (time frame: 21 days). 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 26 Nov 2025.