A Multi-Center InternatiONal Registry to Evaluate the Efficacy oF Imaging With Opto-acoustics to Diagnose BrEast CaNCEr
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 165
- 试验地点
- 3
- 主要终点
- Assessment of the percentage of masses that the Imagio system alone or in combination with other imaging modalities is indicated as impacting the decision to biopsy
研究概览
简要总结
This registry has been designed to obtain real-life, post-market data on the use of the Imagio breast imaging system. This registry is sponsored by Seno Medical Instruments, Inc., the manufacturer of the device.
详细描述
This is a prospective, controlled, multi-center, observational international registry designed to evaluate the Imagio breast imaging system. The registry will be conducted at up to 12 international centers. Investigators will use Imagio US (IUS) and/or Imagio OA/US imaging per standard of care, anddata will be collected accordingly. Additional imaging and biopsy/surgery will be conducted per standard of care to reach a final diagnosis.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Assessment of the percentage of masses that the Imagio system alone or in combination with other imaging modalities is indicated as impacting the decision to biopsy
时间窗: September 2024
This parameter will be reviewed for the Intention-to-Diagnose (ITD) and Per-Protocol (PP) populations
Specificity, negative likelihood ratio, sensitivity and positive likelihood
时间窗: September 2024
This parameter will be reviewed for the Intention-to-Diagnose (ITD) and Per-Protocol (PP) populations
In malignant breast masses, to assess the roles of the Imagio OA/US as a prognostic biomarker
时间窗: September 2024
i.e., the correlation of Imagio OA/US feature scoring with histologic grade, ER and PR hormone receptors, HER2 receptor (IHC and/or HER2 FISH), Ki-67 proliferative index, as well as with molecular subtypes of breast cancer. This parameter will be reviewed for the Intention-to-Diagnose (ITD) and Per-Protocol (PP) populations
Quality of Life Assessment - Testing Morbidity Index
时间窗: September 2024
This parameter will be reviewed for the Intention-to-Diagnose (ITD) and Per-Protocol (PP) populations
次要结局
- Incidence and nature of device deficiencies (i.e. device complaints, device malfunctions)(September 2024)
- Characteristics of lymph node lesions/masses the device is used for(September 2024)
- Incidence and nature of device and procedure related adverse events(September 2024)