Feasibility of Imaging Breast Implants With a Transmission-based Transmission Scanner
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Measurement of regions of interest in microwave images
研究概览
简要总结
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?
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with breast implants placed at least 6 months prior who are asymptomatic for implant rupture as well as those with known implant rupture
- •Minimum of 18 years of age
- •Able to provide informed consent
排除标准
- •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
研究组 & 干预措施
A single arm study to determine feasibility of imaging breast implants
WVI-MIS-03-2025
干预措施: WVI-MIS-03-2025 (Device)
结局指标
主要结局
Measurement of regions of interest in microwave images
时间窗: 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.
次要结局
- Comparison of total area in implant in microwave image with known physical size(12 months)
- Compare microwave scans of the left and right breast(12 months)
研究者
Elise Fear
Professor
University of Calgary