Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 9:18 PM
Study NCT ID:
NCT07487792
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-23
First Post:
2026-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility of Imaging Breast Implants With a Transmission-based Microwave Scanner
Sponsor:
University of Calgary
Organization:
Study Overview
Official Title:
Feasibility of Imaging Breast Implants With a Transmission-based Transmission Scanner
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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. 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?
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?
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: