Evaluation of V5 Lung AI Software With A Two-Arm Comparative Reader Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Comparing the Detection Accuracy, Sensitivity, and Specificity of Clinically Actionable Lung Nodules
研究概览
简要总结
STUDY DESIGN:
This is a two-arm retrospective, multi-reader, multi-case, (MRMC) randomized reader study.
OBJECTIVE:
Primary: The primary objective of this clinical study is to prove that radiologist's performance aided with V5med Lung AI is superior to the unaided for detecting qualified lung nodules.
Secondary: The secondary objective of this clinical study is to prove that the radiologist's reading time is not significantly increased when aided with V5med Lung AI.
Addition Objectives: To prove that the agreement (e.g., in kappa correlation coefficient) between experts and radiologist's Lung-RADS score aided with V5med Lung AI is superior to the unaided.
NUMBER OF SUBJECTS:
Retrospective CT studies from approximately 350 patients will be included in the study with approximately 170 true positive cases and 180 normal cases.
PRIMARY ENDPOINTS:
Scores given by the radiologists with and without V5med Lung AI will be recorded and compared to the true status of the study-cases. The frequency of the scores for each method (Aided, Unaided) will be tabulated and LROC curves constructed along with sensitivity, specificity, PPV, NPV and clinical actions. Additionally, machine nodule detection rate and false positives per patient on normal cases will be measured.
PATIENT POPULATION:
The study will target approximately two hundred (200) patients whose CT lung nodules were shown to be cancer and one hundred and eighty (150) patients who have no lung nodule greater than 4mm. The patient population will be consistent with the national lung cancer screening protocols.
详细描述
Overview of the Study:
A reader study with sixteen participating radiologists will be conducted. A location-specific receiver operating characteristic (LROC) curve will be used to evaluate radiologists' detection performance in detecting qualified lung nodules on chest CT scans with and without the use of the V5med Lung AI system. The reading time for each case will also be recorded.
The 16 study radiologists will be split into two groups, X and Y. The 350 chest CT scans will be split into two subsets, A and B. Group X radiologists will interpret subset A without AI and subset B with V5med Lung AI. Group Y radiologist will interpret subset B without AI and subset A with AI. After a minimum of one month, each radiologist group will interpret the same images again but in the reverse order with regard to study modes (without AI and with AI). Please see Figures 1 and 2 for detailed arrangement of the radiologist interpretation sessions.
During the baseline reading session the radiologist will mark each location of qualified nodules and assign a score. If at least one suspicious nodule is observed, the radiologist will also indicate a Lung-RADS score (i.e., 2, 3, 4A, 4B, or 4X) at the end of case interpretation.
During the second reading (i.e., aided reading) session, the radiologist will be presented with a chest CT with CADe marks displayed on the "left window" and the same chest CT without CADe marks displayed on the "right window". If the radiologist confirms a nodule, the radiologist will mark the location on the chest CT displayed on the right window. This may or may not correspond to the locations of the CADe marks as displayed on the left window. The same as in the baseline study, the radiologist will assign a score (level of suspicion) to each suspicious location and provide a Lung-RADS score for the chest CT case, if at least one location on the CT is marked.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 55 Years 至 77 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Screening chest CT taken of asymptomatic patients age 55 - 77 with history of smoking
- •Non-screening chest CT of an adult (age 18 and older) without comorbidity
- •Primary Lung Cancer, Biopsy-proven with radiology report
- •<= 2.5mm slice spacing, no gaps
- •Standard reconstruction kernels
- •Maximum of 7 lung nodules per CT scan
- •Nodules must be 4-30mm in size (though majority of them will be 20mm or smaller)
排除标准
- •Acute pneumothorax
- •Incomplete inclusion of both lungs, within the field of view, including both Apices
- •Excessive motion artifacts or beam-hardening artifacts
- •Symptomatic patients with co-morbidities
结局指标
主要结局
Comparing the Detection Accuracy, Sensitivity, and Specificity of Clinically Actionable Lung Nodules
时间窗: 6 months
The detection rates in accuracy, sensitivity, and specificity on clinically actionable lung nodules were computed and compared for Aim 1 (baseline) and Arm 2 (study participants were aided with V5med Lung AI) studies.
Comparing LROC Curve in the Detection of Clinically Actionable Lung Nodules Among Normal
时间窗: 6 months
The areas under location-specific Receiver Operating Characteristic (LROC) curves were computed and compared for Aim 1 (baseline) and Aim 2 (study participants were aided with V5med Lung AI).
次要结局
- Average Reading Time Per Case(4 months)