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临床试验/NCT04688086
NCT04688086已完成不适用

A Prospective Study to Evaluate the Effectiveness of Thermalytix (AI-based Thermographic Solution Developed by Niramai) for Breast Cancer Screening as Compared to Standard Screening Modalities for Breast Cancer

Niramai Health Analytix Private Limited1 个研究点 分布在 1 个国家目标入组 687 人开始时间: 2018年12月15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
687
试验地点
1
主要终点
Sensitivity, Specificity, Positive Predictive Value and Negative Predictive Value of Thermalytix

研究概览

简要总结

The purpose of this study is to determine the clinical performance of AI-based Thermalytix with the current standard-of-care diagnostic modalities in women.

详细描述

While mammography is the most accepted breast cancer screening test, it is less sensitive in women with dense breast tissue, who have a four fold high risk for developing breast cancer. Thermalytix is a novel automated breast cancer screening solution that uses artificial intelligence (AI) over thermal images to detect and localise breast cancer lesions in women. In this study the performance of Thermalytix over mammography is evaluated in women with dense and non-dense breast tissue who presented for a health check-up at a hospital. All women underwent Thermalytix and mammography, and participants who were reported as positive on either test were recommended for further investigations. Sensitivity, specificity, positive predictive value, and negative predictive value were calculated across age-groups, menopausal status, and breast densities against the current standard-of-care diagnostic modalities.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Female subjects equal to and above 18 years
  • Subjects who are willing to give written informed consent for study participation
  • Subjects who are ready to comply with the study related visits and procedures

排除标准

  • Subjects who are pregnant
  • Subjects who are lactating
  • Subjects who have undergone either lumpectomy or mastectomy
  • Subjects who have undergone chemotherapy in the last 2 weeks at the time of study enrollment
  • Any active illness, psychological and/or pathological condition that would interfere with study participation in the opinion of the Investigator

结局指标

主要结局

Sensitivity, Specificity, Positive Predictive Value and Negative Predictive Value of Thermalytix

时间窗: 2 days

To assess the clinical performance of Thermalytix as compared to standard screening modalities. Sensitivity, specificity, positive predictive value and negative predictive value of Thermalytix

次要结局

  • Sensitivity and Specificity of Thermalytix for Women With Dense Breast Tissue (ACR Category C or D)(2 days)
  • Sensitivity and Specificity of Thermalytix in Women With Breast Density ACR Category "A" or "B"(2 days)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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