Breast - FemaleNCT07487792
Feasibility of Imaging Breast Implants With a Transmission-based Microwave Scanner
A study testing WVI-MIS-03-2025 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 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: 1. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast - Female
- What is being tested?
- WVI-MIS-03-2025
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 15 Sep 2026to 30 Dec 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women with breast implants placed at least 6 months prior who are asymptomatic for implant rupture as well as those with known implant rupture
- Female
- Minimum of 18 years of age
- Able to provide informed consent
Who cannot join
- Women who are currently pregnant or breastfeeding
- Women with active breast infections
- Women with nipple piercings (unless removed prior to scanning)
- Women with implanted electronic device
- Women with physical limitations that prevent them from placing their breasts inside the scanner
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Demsey Plastic Surgery Clinic
Calgary, Alberta, T3H 3K8
Anita Garland, 403-703-1664, anita.garland@ucalgary.ca
About this study
Official title: Feasibility of Imaging Breast Implants With a Transmission-based Transmission Scanner
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:
- Can a microwave imaging device effectively scan a breast containing implants?
- Can the presence of implants be identified in a microwave scan?
- Can the microwave scans of the left and right breasts be compared to assess whether similarity is observed?
Read the detailed description
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.
- Conditions
- Breast - Female
- Being tested
- WVI-MIS-03-2025
- Keywords
- women, breast implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WVI-MIS-03-2025Device
Microwave scans
| Study group | Role | What they receive |
|---|---|---|
| A single arm study to determine feasibility of imaging breast implants | Experimental | WVI-MIS-03-2025 Receives: Device: WVI-MIS-03-2025 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (2)
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.
Measured: 12 months
Compare microwave scans of the left and right breast
The properties and size of the region corresponding to the implant will be compared between right and left breasts.
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 posted23 Mar 2026
- Study start15 Sep 2026 (estimated)
- Primary completion15 Dec 2026 (estimated)
- Study completion30 Dec 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
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Wave View Imaging Inc.
- Responsible party
- Principal investigator, Elise Fear, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07487792
- Sponsor's protocol ID
- REB25-0914
- Status last verified
- Mar 2026
- First submitted
- 17 Mar 2026
- 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
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.
PubMed 40940299Mojabi 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.
PubMed 40587354Mojabi 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.
PubMed 40815587Smith, 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.
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.
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 40031671
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 Imaging Breast Implants With a Transmission-based Transmission Scanner
- ClinicalTrials.gov ID
- NCT07487792
- Acronym / sponsor ID
- REB25-0914
- Conditions
- Breast - Female
- Keywords
- women, breast implant
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Wave View Imaging Inc.
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 23 Mar 2026 (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 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:
- Can a microwave imaging device effectively scan a breast containing implants?
- Can the presence of implants be identified in a microwave scan?
- Can the microwave scans of the left and right breasts be compared to assess whether similarity is observed?
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A single arm study to determine feasibility of imaging breast implants | Experimental | Device: WVI-MIS-03-2025WVI-MIS-03-2025 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women with breast implants placed at least 6 months prior who are asymptomatic for implant rupture as well as those with known implant rupture
- Female
- Minimum of 18 years of age
- Able to provide informed consent
Key exclusion criteria (5 listed)
- Women who are currently pregnant or breastfeeding
- Women with active breast infections
- Women with nipple piercings (unless removed prior to scanning)
- Women with implanted electronic device
- Women with physical limitations that prevent them from placing their breasts inside the scanner
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-03-2025Microwave scans | Device | A single arm study to determine feasibility of imaging breast implants |
Primary outcome
Measurement of regions of interest in microwave images
Time frame: 12 months
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.
2 secondary outcomes
Comparison of total area in implant in microwave image with known physical size
Time frame: 12 months
Compare microwave scans of the left and right breast
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.
- Background: PubMed 40940299Mojabi 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.
- Background: PubMed 40587354Mojabi 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.
- Background: PubMed 40815587Mojabi 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.
- BackgroundSmith, 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.
- BackgroundButterworth, 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.
- Background: 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.
- 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.
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-03-2025 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 4 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: opening soon, 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?
Contact Anita Garland (403-703-1664, anita.garland@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of regions of interest 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 NCT07487792, 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; AzTrials last refreshed its copy on 6 Nov 2026.