跳至主要内容
临床试验/NCT05084729
NCT05084729已完成不适用

A Multi-Center InternatiONal Registry to Evaluate the Efficacy oF Imaging With Opto-acoustics to Diagnose BrEast CaNCEr

Seno Medical Instruments Inc.3 个研究点 分布在 1 个国家目标入组 165 人开始时间: 2020年9月11日最近更新:
适应症

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

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)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (3)

Loading locations...

相似试验