Multinational, Multicenter, Retrospective Study to Evaluate an AI/ML Technology-Based End-to-End CADe/CADx SaMD, Which Allows Detection, Localization and Characterization of Pulmonary Nodules (REALITY)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,147
- 试验地点
- 5
- 主要终点
- AUROC (Area under ROC curve) at patient level
研究概览
简要总结
This is a Multinational, Multicenter, retrospective study for the evaluation of the standalone efficacy and safety of an Artificial Intelligence/Machine Learning (AI/ML) technology-based end-to-end Computer assisted Detection/Computer Assisted Diagnosis (CADe/CADx) Software as a Medical Device (SaMD) developed to detect, localize and characterize malignant, and suspicious for lung cancer nodules on Low Dose Computed Tomography (LDCT) scans taken as part of a Lung Cancer Screening (LCS) program.
LDCT Digital Imaging and Communications in Medicine (DICOM) images of patients who underwent lung cancer screening were selected and included into the study. Selected scans will then be analyzed by the CADe/CADx SaMD and compared to radiologist generated reference standards including lesions localization and lesion cancer diagnosis.
Figures of merit at patient level and lesion level detection and diagnostic efficacy will be calculated as well as sub-class analysis to ensure algorithm performance generalizability.
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
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •≥50-80 Years of age;
- •Current or ex-smoker (>=20 pack years);
- •Patient screened and surveilled for lung cancer screening following lung cancer screening guidelines (equivalent to United States Preventive Services Task Force (USPSTF) 2021 Criteria);
- •Received LDCT due to inclusion in high-risk category for lung cancer.
排除标准
- •Prior lung resection;
- •Pacemaker or other indwelling metallic medical devices in the thorax that interfere with CT acquisition;
- •Patients/images used during AI model development;
- •Patients with only hilar and/or mediastinal cancer(s);
- •Patients with only ground glass cancer(s);
- •Patients with nodules, solid or part-solid >30mm (masses);
- •Patients that are not accompanied with the required clinical information;
- •Patients with imaging with any of the following: missing slices, slice thickness >3mm;
- •Partial cover of the lung.
结局指标
主要结局
AUROC (Area under ROC curve) at patient level
时间窗: 12 months
AUROC that measures Median LCS performance at patient level is strictly superior to 0.8. Support for Primary Endpoint: Derived from the patient level AUROC at the product fixed operating point : Sensitivity, Specificity, PPV, NPV.
次要结局
- ICC>0.8 for long axis diameter(12 months)
- ICC>0.8 for short axis diameter(12 months)
- ICC>0.75 for Volume(12 months)
- Sensitivity > 70% when Specificity=70%(12 months)
- Detection sensitivity>0.8 with average FP rate per scan<1(12 months)
- ICC>0.8 for average diameter(12 months)
- DICE Coefficient >0.7(12 months)
- Specificity > 70% when Sensitivity=70%(12 months)
- AUC of LROC > 0.75(12 months)