An interventional study of WVI-MIS-02-2025 in Breast - Female, sponsored by University of Calgary. Enrolling by invitation at 1 site in Canada. Open to female participants aged 18 Years to 74 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-25.
Sponsored by University of Calgary · Not applicable, Interventional, and Other
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:
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.
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.
University of Calgary is the lead sponsor of 686 studies on the registry; 189 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 2 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
A single arm study in which the collected microwave data is compared against available clinical data.
Device: WVI-MIS-02-2025
Microwave scans
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.
Time frame: 12 months
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.
Time frame: 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.
Time frame: 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.
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
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.
Time frame: 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.
Time frame: 12 months
Plan to share: No
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