The ABC Study: Assessment of Breast Density Classification Via Algorithm Development Using Microwave Imaging in Breast Clinics
试验速览
- 阶段
- 不适用
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- The creation of that algorithm
研究概览
简要总结
The MARIA® breast imaging system is a CE-marked radiofrequency (RF) medical imaging device. The system employs an electromagnetic imaging technique that exploits the dielectric contrast between normal and cancerous tissues. It is the intention that MARIA® will be able to offer a breast density classifier to clinician's but for this project to be successful, data is required. This study will collect the data required for the classifier to be developed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •To be eligible to participate in this study, a subject must meet all the following criteria:
- •Attending a symptomatic or assessment breast clinic at the study site
- •Female sex
- •18 years or older
- •Able to provide informed consent
- •Not in any identified, vulnerable group
排除标准
- •A potential subject who meets any of the following criteria will be excluded from participation in this study:
- •Unable to mount MARIA® patient bed
- •Unable to lie in the prone position for a period of up to 15 minutes
- •Patients who have undergone biopsy less than 5 days before the MARIA® scan
- •Patients with implanted electronics
- •Patients with breast implants
- •Patients with nipple piercings (unless they are removed prior to the MARIA® scan)
- •Breast sizes too small or too large to be suitable for the array
- •Participants recruited the same day are not subject to any additional screening criteria other than that described above. However, participants being recruited and consenting to the use of previously- taken mammography will need to provide information on key points in order to assess the eligibility of their mammograms for use. This will include information on:
- •Whether they have initiated or discontinued use of a hormonal contraceptive since their last mammogram
- •Whether they have initiated or discontinued use of hormone replacement therapy since their last mammogram
- •Whether they believe that they have had a change in menopausal status since their last mammogram Participants who answer yes to any of the above will not be eligible for participation.
研究组 & 干预措施
Main study group
干预措施: Bilateral MARIA scan (Device)
结局指标
主要结局
The creation of that algorithm
时间窗: 12 months
Using the current breast density algorithm developed for MARIA to analyse the MARIA images and compare that to the mammographic ground truth
The creation of the required dataset to develop the breast density classification algorithm
时间窗: 12 months
Dataset of information containing ground truth breast density from mammogram
The assessment of the performance of that algorithm to measure breast density when compared to the ground truth of the Boyd score
时间窗: 12 months
Analyse the values obtained from both the MARIA algorithm and the mammographic ground truth, and look for correlation using the Boyd percentage score of breast density.
次要结局
- Understand participant acceptability of the MARIA® scan(12 months)