Evaluation of Diagnostic Accuracy and Validation of LIRA: AI-Driven Radiological Software for Tuberculosis Screening and Other Abnormalities in Adult Chest X-Rays
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 5,640
- 试验地点
- 1
- 主要终点
- This study will evaluate the diagnostic accuracy of LIRA in TB screening and detection of other chest abnormalities by comparing its sensitivity and specificity to the performance with that of expert radiologists
研究概览
简要总结
The purpose of this study is to evaluate the diagnostic accuracy and validate the performance ofLIRA AI Tool, in detecting Pulmonary TB and other key clinical findings or abnormalities from adult chestX-rays and to compare its results with those of expert radiologists.
The objectives of this clinical study are divided into two major group studies:
**Retrospective study:**The primary objective is to assess LIRA’s sensitivity, specificity, positive predictive value, andnegative predictive value in detecting tuberculosis (TB) versus the reference standardmicrobiological confirmation using previously collected chest X-ray data.The secondary objective is to compare LIRA’s sensitivity, specificity, positive predictive value,and negative predictive value in detecting tuberculosis (TB) versus a radiologist’s opinion usingpreviously collected chest X-ray data.
Prospective study:The primary objective is to evaluate LIRA’s accuracy and reliability in real-time TB detection,aiming to enhance diagnostic speed and efficiency.Page 9 of 74CMT_LIRA_001Version 01The secondary objective focuses on LIRA’s impact on radiologist workflows, specifically itsintegration with PACS, its effect on turnaround times, and its capacity to prioritize high-risk casesin clinical and community settings.
This is a case-control design and prospective cohort study designed to evaluate the clinical efficacyand diagnostic accuracy of LIRA, an AI-powered radiology software, in identifying abnormalitiesassociated with tuberculosis (TB) on CXR in AP/PA views.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Retrospective Phase: a.
- •Archived chest X-ray images of adult patients, aged 18 years and older , collected within the last 6 months.
- •Minimum image resolution of 1440 x 1440 pixels.
- •Availability of corresponding microbiological test results.
- •No prior diagnosis or treatment for active TB within the past 6 months.
- •Prospective Phase: a.
- •Adults aged 18 years and above presenting for chest X-rays due to suspected TB.
排除标准
- •Retrospective phase: a.
- •Incomplete or poor-quality CXR images.
- •Patients under 18 years of age.
- •Absence of corresponding microbiological test results or clinical data.
- •Prior diagnosis or treatment for active TB within the past 6 months.
- •Prospective Phase: a.
- •Pregnant or lactating individuals (due to radiation exposure).
- •Patients with severe respiratory distress require immediate clinical intervention.
- •Inability to comply with the study protocol due to cognitive impairments or severe comorbidities.
结局指标
主要结局
This study will evaluate the diagnostic accuracy of LIRA in TB screening and detection of other chest abnormalities by comparing its sensitivity and specificity to the performance with that of expert radiologists
时间窗: 6 months
次要结局
- This study will examine the impact of LIRA on clinical workflow efficiency, diagnostic speed, and the qualitative feedback from radiologists regarding its usability.(6 months)