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| Name | Class |
|---|---|
| Wave View Imaging Inc. | UNKNOWN |
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The goal of this clinical trial is to assess whether microwave scans can depict the presence of implants in the breast in women with existing breast implants that were surgically placed at least 6 months ago. The main questions it aims to answer are:
Breast implants are consistently one of the top 5 cosmetic procedures performed each year in North America. The Food and Drug Administration (FDA) cites a 10% risk of rupture over 10 years (1% cumulative per annum risk of device rupture).
Rupture refers to disruption in the integrity of the implant, and is typically age-related deterioration where age in this context refer to the implant. Rupture in saline implants is detected with rapid change in breast size. With silicone implants, rupture is much more challenging to detect as it is rare to have a completely collapsed implant shell.
Current recommendations for surveillance of breast implants include Magnetic Resonance Imaging (MRI) or ultrasound within 5-6 years of surgery for the initial test, then every 2-3 years. The guideline initially included only MRI but was adjusted in 2022 to include ultrasound. Patient adherence to guidelines with only MRI was very low (less than 5%), which is postulated to relate to the expense, discomfort, and inaccessibility of MRI. Mammography is a frequently used breast imaging method. However, the majority of women with implants are too young for breast screening programs that involve regular mammograms. Also, the implant is displaced during mammography to focus on the breast tissues. Finally, mammography involves exposure to x-rays, limiting regular scans in women too young for screening.
Therefore, there is a need to regularly inspect silicone implants for silent rupture. An imaging approach that is low-cost, available at point-of-care, easy to use, and reliable (i.e. sensitive to implant rupture) would be a valuable tool for plastic surgery clinics.
Microwave imaging has been proposed as a low-cost and comfortable approach to breast imaging that can be performed at point of care. This approach to imaging is low power, so no tissue heating occurs and there are no other side effects. Therefore, microwave imaging is suited to in-clinic, ongoing monitoring of the breast.
10 women with breast implants will be recruited from plastic surgery clinics. This includes women with breast implants that were surgically placed at least 6 months prior and are asymptomatic for implant rupture, as well as women who have implants with a confirmed rupture. Study participants will be scanned with the microwave imaging system. Three scans of each breast will be collected in each of the Craniocaudal (CC) and Mediolateral Oblique (MLO) views.
The breast positioning will be adjusted between scans to maximize the presentation of the implant in the imaging volume. The images will be analyzed to identify the implants, as the implants have different properties when compared to healthy breast tissues.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A single arm study to determine feasibility of imaging breast implants | Experimental | WVI-MIS-03-2025 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WVI-MIS-03-2025 | Device | Microwave scans |
|
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of regions of interest in microwave images | Images of both breasts will be created. Regions of interest corresponding to the breast implants will be identified using the electrical properties. The size of these regions will be calculated. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of total area in implant in microwave image with known physical size | The total area corresponding to the breast implant in the microwave images will be calculated and compared with the known implant size. | 12 months |
| Compare microwave scans of the left and right breast |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anita Garland | Contact | 403-703-1664 | anita.garland@ucalgary.ca | |
| Elise Fear | Contact | 403-210-5413 | fear@ucalgary.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Demsey Plastic Surgery Clinic | Calgary | Alberta | T3H 3K8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40940299 | Background | Mojabi P, Tsang RY, Docktor B, Deutscher D, Garland A, Mahsin M, Bourqui J, Fear E. Feasibility of tumor detection with a transmission-based microwave imaging system. Med Phys. 2025 Sep;52(9):e18080. doi: 10.1002/mp.18080. | |
| 40587354 | Background | Mojabi P, Bourqui J, Docktor BJ, Tsang RY, Fear E. Assessment of Breast Composition With a Transmission-Based Microwave Imaging System. IEEE Trans Biomed Eng. 2026 Jan;73(1):451-461. doi: 10.1109/TBME.2025.3584669. |
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The properties and size of the region corresponding to the implant will be compared between right and left breasts. |
| 12 months |
| 40815587 | Background | Mojabi P, Tsang RY, Docktor BJ, Deutscher D, Garland A, Lasemiimeni Z, Bourqui J, Fear E. Point-of-Care Breast Imaging for Monitoring Neoadjuvant Treatment: Case Studies With Transmission-Based Microwave Imaging. IEEE Trans Biomed Eng. 2026 Mar;73(3):1181-1190. doi: 10.1109/TBME.2025.3599516. |
| Background | Smith, 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. |
| Background | Butterworth, Carina M., et al. "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, vol. 9, no. 3, 2025, pp. 335-43, https://doi.org/10.1109/JERM.2025.3531693. |
| 40031671 | Background | 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. |