Evaluation of Carebot AI MMG Medical Device for Detection and Radiographic Assessment of Breast Lesions and Quantitative Analysis of Breast Density: A Multicentric, Multi-Reader Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 122
- 试验地点
- 3
- 主要终点
- Performance Test
研究概览
简要总结
Comparison of accuracy of clinician and DLAD image evaluation (Carebot AI MMG v2.2)
- Comparison of the Accuracy of Density Assessment by Clinician and DLAD (DENS)
- Comparison of Accuracy of Lesion Assessment by Clinician and DLAD (MASS, CLASS)
详细描述
The mammography studies were acquired from three independent sites: Site 1 (EUC Mamocentrum Brno) and Site 2 (Hospital Šumperk, a.s.) specialise in routine screening mammography, and Site 3 (Masaryk Memorial Cancer Institute) is a comprehensive oncology facility primarily dedicated to diagnostic mammography, i.e. performing additional examinations in case of a suspicious finding (recall).
The ground truth was obtained by consensus of two board-certified radiologists with expertise in radiology and diagnostic methods, and 13 and 27 years of experience with mammography image interpretation, respectively.
For comparative analysis, a team of five independent radiologists with clinical experience in interpreting mammography images was established. Three of the clinicians were junior (2, 2, and 4 years of experience, respectively) without board-certification; two physicians were senior (7 and 8 years of experience, respectively), board-certified.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •The medical device is intended for use in women over 18 years of age who are indicated for screening mammography using digital mammography.
排除标准
- •The medical device cannot be used in patients with breast implants.
- •The medical device cannot be used in male breast examination.
- •The medical device cannot be used in patients under 18 years of age.
研究组 & 干预措施
Retrospective collection of DICOM patient files for Site 1
A total of 60 mammographic studies were retrospectively collected from Site 1 (EUC Mamocentrum Brno).
The acquisition of mammography studies from Site 1 was enabled by the contract for the transfer of mammography images for medical research purposes, signed on 14 January 2022.
干预措施: Carebot AI MMG (Device)
Retrospective collection of DICOM patient files for Site 2
A total of 28 mammographic studies were retrospectively collected from Site 2 (Hospital Šumperk, a.s.).
The acquisition of mammography studies from Institution 2 was enabled by the contract for the transfer of mammography images for medical research purposes, signed on 31 January 2023.
干预措施: Carebot AI MMG (Device)
Retrospective collection of DICOM patient files for Site 3
A total of 34 mammographic studies were retrospectively collected from Site 3 (Masaryk Memorial Cancer Institute).
The acquisition of mammography studies from Institution 3 was enabled by the amendment to the contract for the transfer of X-ray images for medical research purposes, signed on 21 February 2023, which follows the contract for the transfer of X-ray images for medical research purposes, signed on 3 January 2022.
干预措施: Carebot AI MMG (Device)
结局指标
主要结局
Performance Test
时间窗: 2024
A multicenter, multi-reader, retrospective study was designed to validate the clinical efficacy of the proposed Carebot AI MMG (also referred to as "DLAD"). Using a non-certified medical device, a test set of retrospectively collected mammography studies in standard projections (CC and MLO). The performance of the DLAD was evaluated against the ground truth for individual indications (breast density evaluation, breast lesion detection) using Accuracy.
次要结局
- Comparison of Accuracy of Clinician and DLAD Image Evaluation (Carebot AI MMG v2.2) in Breast Density Assessment(2024)
- Comparison of Accuracy of Clinician and DLAD Image Evaluation (Carebot AI MMG v2.2) in Breast Lesion Detection(2024)