Feasibility of Imaging Breast Implants With a Transmission-based Microwave Scanner

March 17, 2026 updated by: Elise Fear, University of Calgary

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:

  1. Can a microwave imaging device effectively scan a breast containing implants?
  2. Can the presence of implants be identified in a microwave scan?
  3. Can the microwave scans of the left and right breasts be compared to assess whether similarity is observed?

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T3H 3K8

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A single arm study to determine feasibility of imaging breast implants
WVI-MIS-03-2025
Device: WVI-MIS-03-2025
Microwave scans

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of total area in implant in microwave image with known physical size
Time Frame: 12 months
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
Time Frame: 12 months
The properties and size of the region corresponding to the implant will be compared between right and left breasts.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Calgary

Collaborators

Wave View Imaging Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 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.
  • Mojabi, Pedram, et al. "Feasibility of Tumor Detection with a Transmission-based Microwave Imaging System." Medical Physics (Lancaster), vol. 52, no. 9, 2025, pp. e18080-n/a, https://doi.org/10.1002/mp.18080.
  • Mojabi, Pedram, et al. "Assessment of Breast Composition with A Transmission-Based Microwave Imaging System." IEEE Transactions on Biomedical Engineering, vol. 73, no. 1, 2025, pp. 1-11, https://doi.org/10.1109/TBME.2025.3584669.
  • Mojabi, Pedram, et al. "Point-of-Care Breast Imaging for Monitoring Neoadjuvant Treatment: Case Studies with Transmission-Based Microwave Imaging." IEEE Transactions on Biomedical Engineering, vol. PP, 2025, pp. 1-10, https://doi.org/10.1109/TBME.2025.3599516.
  • 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, Pedram, et al. "Microwave Imaging for Breast Cancer Detection: Performance Assessment of a Next-Generation Transmission System." IEEE Transactions on Biomedical Engineering, vol. 72, no. 6, 2025, pp. 1787-99, https://doi.org/10.1109/TBME.2024.3521410.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 15, 2026

Primary Completion (Estimated)

November 15, 2026

Study Completion (Estimated)

November 15, 2026

Study Registration Dates

First Submitted

March 17, 2026

First Submitted That Met QC Criteria

March 17, 2026

First Posted (Actual)

March 23, 2026

Study Record Updates

Last Update Posted (Actual)

March 23, 2026

Last Update Submitted That Met QC Criteria

March 17, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • REB25-0914

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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