Breast - FemaleNCT07273565
Feasibility of Comparing Microwave Images to Clinical Information in Patients Recalled for Follow-up Breast Imaging
A study testing WVI-MIS-02-2025 in people with Breast - Female, run by University of Calgary at 1 site in Canada.
Trial summary
The goal of this clinical trial is to measure the electrical properties of breast tissues using microwave technology and to compare these collected measurements to clinical information in mammograms and/or breast ultrasound for women that have been recalled for follow-up breast imaging or further investigation. Read more about this study
- Who is it for?
- Ages 18 to 74 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast - Female
- What is being tested?
- WVI-MIS-02-2025
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 19 Mar 2026to 30 Oct 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 18 to 74 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female sex
- 18-74 years of age
- Able to provide informed consent
- Had a screening or diagnostic mammogram or breast ultrasound within the previous 6 weeks
- Recalled for additional breast imaging due to BIRADS 3 or 4 or 5 findings.
Who cannot join
- Participants who have not received a mammogram or breast ultrasound
- Participants who are currently undergoing breast cancer treatment or have had treatment in the past 6 months
- Participants with breast implants
- Participants who are pregnant or breastfeeding
- Participants with active breast skin infections
- Participants with nipple piercings (unless they are removed prior to scanning)
- Participants with an implanted electronic device
- Participants with physical limitations that prevent them from placing their breasts inside the Wave View scanner.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The goal of this clinical trial is to measure the electrical properties of breast tissues using microwave technology and to compare these collected measurements to clinical information in mammograms and/or breast ultrasound for women that have been recalled for follow-up breast imaging or further investigation. The main questions it aims to answer are:
- Can the breast area and plate separation in the microwave scan be compared to mammogram data (where available) to assess similarity in breast positioning and the feasibility of image registration?
- Can the distribution of electrical properties specifically glandular tissue distribution in the microwave image be compared to that observed in the mammogram (where available)?
- Can the characteristics of the microwave image in the localized region corresponding to an identified anomaly in the breast imaging data be examined?
Study participants will be scanned with the Wave View microwave scanner on the same day as their follow-up breast imaging appointment. Each breast will be scanned up to 3 times with the scanner oriented in both the horizontal position and oriented at 45 degrees. Study participants will also be asked to fill out three surveys, one relating to breast health and the other two relating to their scanning experience.
Read the detailed description
A new approach to imaging that uses low-power microwaves to scan the breast has been developed. Since the imaging system uses low power, there is no risk of tissue heating. The imaging system places the sensors in contact with the breast tissue. The research team at the University of Calgary has previously developed microwave imaging systems that have been tested on healthy volunteers and breast cancer patients. A group of healthy volunteers were repeatedly scanned to evaluate the consistency of the imaging approach. Another study involved scanning breast cancer patients before each round of neoadjuvant chemotherapy. The information collected from experiences scanning volunteers and patients have been reviewed and translated into a next-generation imaging system design. Aspects of this system have been further improved by Wave View Imaging, which is a company formed by members of the University's research team.
The proposed study involves collecting electrical property measurements of breast tissues and comparing these measurements to clinical information in mammograms and/or breast ultrasounds. The investigators also aim to compare regions of interest in the microwave scans with regions of interest in the mammograms (where available). This includes regions dominated by fibroglandular tissues, as well as regions of interest that correspond to anomalies identified in the mammograms and/or breast ultrasounds.
The plan is to scan both breasts of up to 100 volunteers that have been recalled for follow-up breast imaging or further investigation. Each volunteer will participate in a single scanning session during their follow-up appointment. Breast tissue composition will be compared with the microwave properties and registration of mammograms (where available) with microwave images will be performed for a more detailed comparison.
- Conditions
- Breast - Female
- Being tested
- WVI-MIS-02-2025
- Keywords
- women, mammography, recall, breast, breast ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WVI-MIS-02-2025Device
Microwave scans
| Study group | Role | What they receive |
|---|---|---|
| WVI-MIS-02-2025 | Experimental | A single arm study in which the collected microwave data is compared against available clinical data. Receives: Device: WVI-MIS-02-2025 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of electrical properties of breast tissues in microwave images
The average electrical properties of the Wave View image will be calculated (relative permittivity and attenuation). The average properties of the right and left breasts will be compared. The average properties of the craniocaudal (CC) and mediolateral oblique (MLO) views will also be compared for both breasts.
Measured: 12 months
Secondary outcomes (5)
Examine the similarity in plate separation between mammography and Wave View scans
The separation between the plates contacting the breast will be compared between the two modalities. This comparison provides an initial indication of the volume of breast tissue in the scanner.
Measured: 12 months
Breast area
The breast area on the mammogram will be compared to the breast area on the Wave View scan. The breast area in the Wave View image will be calculated, while the breast area on the mammogram is available from automated image analysis reports.
Measured: 12 months
Examine the similarity between glandular tissue distribution on mammograms and electrical property images obtained with the Wave View scanner.
The microwave image will be overlayed on the mammogram to provide initial insight on glandular tissue distribution via visual inspection. The images will be registered based on the outline of the breast. If the breast areas are found to differ, deformable registration techniques will be applied. Higher intensity regions representing glandular tissues will be identified in both images via image filtering and segmentation. These regions will be compared with metrics such as the Dice coefficient. In addition, the area of the higher intensity region will be compared with the overall area of the breast image, similar to the method used to calculate the percentages used in breast density analysis.
Measured: 12 months
Examine how closely the presence of responses in Wave View scans correspond to anomalies detected on mammograms and/or breast ultrasounds
Localized regions in the Wave View image that correspond to locations of anomalies on the mammogram or breast ultrasounds will be identified based on the registered images. The average properties of these regions will be compared with the average properties of a region in the same breast, as well as in the contralateral breast.
Measured: 12 months
Estimate of breast composition
Pureform Radiology uses a breast density tool to automatically calculate the volume of the breast and glandular tissue, as well as the percentage density and density category (A, B, C, D). Microwave properties are expected to be greater with greater breast densities.To compare electrical properties to breast density, average electrical properties of each microwave scan will be plotted against the corresponding percent density.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start19 Mar 2026
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Breast - FemaleStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Pureform Radiology, Wave View Imaging Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07273565
- Sponsor's protocol ID
- HREBA.CC-25-0255
- Status last verified
- Sep 2025
- First submitted
- 18 Nov 2025
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
C. M. Butterworth, P. Mojabi, and E. C. Fear, "Quantifying Consistency of Microwave Breast Imaging: Laser Scanning for Assessing Breast Volume and Shape," IEEE Journal of Electromagnetics, RF and Microwaves in Medicine and Biology, pp. 1-9, 2025, doi: 10.1109/JERM.2025.3531693
Mojabi P, Bourqui J, Lasemiimeni Z, Grewal B, Fear E. Microwave Imaging for Breast Cancer Detection: Performance Assessment of a Next-Generation Transmission System. IEEE Trans Biomed Eng. 2025 Jun;72(6):1787-1799. doi: 10.1109/TBME.2024.3521410.
PubMed 40031671Wang Z, Mojabi P, Price S, Lasemiimeni Z, Besler B, Bourqui J, Deutscher D, Besler B, Shen H, Docktor B, Tsang RY, Fear E. Reproducibility of Microwave Breast Imaging: Analysis of Regular Scans of a Group of Volunteers. IEEE Trans Biomed Eng. 2025 May;72(5):1562-1571. doi: 10.1109/TBME.2024.3512572. Epub 2025 Apr 22.
PubMed 40030750Mojabi P, Bourqui J, Fear E. Fast 3D Breast Imaging With a Transmission-Based Microwave System. IEEE Trans Med Imaging. 2025 May;44(5):2206-2217. doi: 10.1109/TMI.2025.3527916. Epub 2025 May 2.
PubMed 40030952Smith K, Bourqui J, Wang Z, Besler B, Lesiuk M, Roumeliotis M, Quirk S, Grendarova P, Pinilla J, Price S, Docktor B, Fear E. Microwave imaging for monitoring breast cancer treatment: A pilot study. Med Phys. 2023 Nov;50(11):7118-7129. doi: 10.1002/mp.16756. Epub 2023 Oct 6.
PubMed 37800880Smith, K., et al. "Microwave Imaging of the Breast: Consistency of Measurements Over Time." IEEE Journal of Electromagnetics, RF and Microwaves in Medicine and Biology, vol. 6, no. 1, 2022, pp. 61-67, https://doi.org/10.1109/JERM.2021.3099014. . : . .
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Comparing Microwave Images to Clinical Information in Patients Recalled for Follow-up Breast Imaging
- ClinicalTrials.gov ID
- NCT07273565
- Acronym / sponsor ID
- HREBA.CC-25-0255
- Conditions
- Breast - Female
- Keywords
- women, mammography, recall, breast, breast ultrasound
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Pureform Radiology, Wave View Imaging Inc.
- Study start
- 19 Mar 2026 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 9 Dec 2025 (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.
The goal of this clinical trial is to measure the electrical properties of breast tissues using microwave technology and to compare these collected measurements to clinical information in mammograms and/or breast ultrasound for women that have been recalled for follow-up breast imaging or further investigation. The main questions it aims to answer are:
- Can the breast area and plate separation in the microwave scan be compared to mammogram data (where available) to assess similarity in breast positioning and the feasibility of image registration?
- Can the distribution of electrical properties specifically glandular tissue distribution in the microwave image be compared to that observed in the mammogram (where available)?
- Can the characteristics of the microwave image in the localized region corresponding to an identified anomaly in the breast imaging data be examined?
Study participants will be scanned with the Wave View microwave scanner on the same day as their follow-up breast imaging appointment. Each breast will be scanned up to 3 times with the scanner oriented in both the horizontal position and oriented at 45 degrees. Study participants will also be asked to fill out three surveys, one relating to breast health and the other two relating to their scanning experience.
Detailed description
A new approach to imaging that uses low-power microwaves to scan the breast has been developed. Since the imaging system uses low power, there is no risk of tissue heating. The imaging system places the sensors in contact with the breast tissue. The research team at the University of Calgary has previously developed microwave imaging systems that have been tested on healthy volunteers and breast cancer patients. A group of healthy volunteers were repeatedly scanned to evaluate the consistency of the imaging approach. Another study involved scanning breast cancer patients before each round of neoadjuvant chemotherapy. The information collected from experiences scanning volunteers and patients have been reviewed and translated into a next-generation imaging system design. Aspects of this system have been further improved by Wave View Imaging, which is a company formed by members of the University's research team.
The proposed study involves collecting electrical property measurements of breast tissues and comparing these measurements to clinical information in mammograms and/or breast ultrasounds. The investigators also aim to compare regions of interest in the microwave scans with regions of interest in the mammograms (where available). This includes regions dominated by fibroglandular tissues, as well as regions of interest that correspond to anomalies identified in the mammograms and/or breast ultrasounds.
The plan is to scan both breasts of up to 100 volunteers that have been recalled for follow-up breast imaging or further investigation. Each volunteer will participate in a single scanning session during their follow-up appointment. Breast tissue composition will be compared with the microwave properties and registration of mammograms (where available) with microwave images will be performed for a more detailed comparison.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| WVI-MIS-02-2025 | Experimental | Device: WVI-MIS-02-2025A single arm study in which the collected microwave data is compared against available clinical data. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female sex
- 18-74 years of age
- Able to provide informed consent
- Had a screening or diagnostic mammogram or breast ultrasound within the previous 6 weeks
- Recalled for additional breast imaging due to BIRADS 3 or 4 or 5 findings.
Key exclusion criteria (8 listed)
- Participants who have not received a mammogram or breast ultrasound
- Participants who are currently undergoing breast cancer treatment or have had treatment in the past 6 months
- Participants with breast implants
- Participants who are pregnant or breastfeeding
- Participants with active breast skin infections
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 |
|---|---|---|
| WVI-MIS-02-2025Microwave scans | Device | WVI-MIS-02-2025 |
Primary outcome
Measurement of electrical properties of breast tissues in microwave images
Time frame: 12 months
The average electrical properties of the Wave View image will be calculated (relative permittivity and attenuation). The average properties of the right and left breasts will be compared. The average properties of the craniocaudal (CC) and mediolateral oblique (MLO) views will also be compared for both breasts.
5 secondary outcomes
Examine the similarity in plate separation between mammography and Wave View scans
Time frame: 12 months
Breast area
Time frame: 12 months
Examine the similarity between glandular tissue distribution on mammograms and electrical property images obtained with the Wave View scanner.
Time frame: 12 months
Examine how closely the presence of responses in Wave View scans correspond to anomalies detected on mammograms and/or breast ultrasounds
Time frame: 12 months
Estimate of breast composition
Time frame: 12 months
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 25 Jun 2026.
- Results publicationC. M. Butterworth, P. Mojabi, and E. C. Fear, "Quantifying Consistency of Microwave Breast Imaging: Laser Scanning for Assessing Breast Volume and Shape," IEEE Journal of Electromagnetics, RF and Microwaves in Medicine and Biology, pp. 1-9, 2025, doi: 10.1109/JERM.2025.3531693
- Results publication: PubMed 40031671Mojabi P, Bourqui J, Lasemiimeni Z, Grewal B, Fear E. Microwave Imaging for Breast Cancer Detection: Performance Assessment of a Next-Generation Transmission System. IEEE Trans Biomed Eng. 2025 Jun;72(6):1787-1799. doi: 10.1109/TBME.2024.3521410.
- Results publication: PubMed 40030750Wang Z, Mojabi P, Price S, Lasemiimeni Z, Besler B, Bourqui J, Deutscher D, Besler B, Shen H, Docktor B, Tsang RY, Fear E. Reproducibility of Microwave Breast Imaging: Analysis of Regular Scans of a Group of Volunteers. IEEE Trans Biomed Eng. 2025 May;72(5):1562-1571. doi: 10.1109/TBME.2024.3512572. Epub 2025 Apr 22.
- Results publication: PubMed 40030952Mojabi P, Bourqui J, Fear E. Fast 3D Breast Imaging With a Transmission-Based Microwave System. IEEE Trans Med Imaging. 2025 May;44(5):2206-2217. doi: 10.1109/TMI.2025.3527916. Epub 2025 May 2.
- Results publication: PubMed 37800880Smith K, Bourqui J, Wang Z, Besler B, Lesiuk M, Roumeliotis M, Quirk S, Grendarova P, Pinilla J, Price S, Docktor B, Fear E. Microwave imaging for monitoring breast cancer treatment: A pilot study. Med Phys. 2023 Nov;50(11):7118-7129. doi: 10.1002/mp.16756. Epub 2023 Oct 6.
- Results publicationSmith, K., et al. "Microwave Imaging of the Breast: Consistency of Measurements Over Time." IEEE Journal of Electromagnetics, RF and Microwaves in Medicine and Biology, vol. 6, no. 1, 2022, pp. 61-67, https://doi.org/10.1109/JERM.2021.3099014. . : . .
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WVI-MIS-02-2025 in people with Breast - Female, run by University of Calgary at 1 site in Canada.
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 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: enrolling by invitation, as of the sponsor's last update on 25 Jun 2026. 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 Canada. 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?
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?
Measurement of electrical properties of breast tissues in microwave images (time frame: 12 months). 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 NCT07273565, which also lists 6 linked publications.
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 25 Jun 2026.