Computer-Aided System for the Improvement of Nodule Detection and Characterization in Thoracic CT Based on a Novel Vessel Suppressed CT Volume
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 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 retrospective, multi-reader, multi-case, (MRMC) randomized reader study.
OBJECTIVE:
Primary: The primary objective of this clinical study is to prove that a user aided with ClearRead CT InSight (CRCTI) is superior to the unaided reader for detecting actionable lung nodules.
Secondary: The secondary objective of this clinical study is to prove that the reader's reading time is not significantly increased when aided with CRCTI.
NUMBER OF SUBJECTS:
Retrospective CT studies from approximately 300 patients will be included in the study. Approximately 100 true positive cases and 200 normal cases.
NUMBER OF READERS:
A reader study with at least ten (10) participating radiologists (US Board Certified) will be conducted.
PRIMARY ENDPOINTS:
Scores given by the radiologists with and without ClearRead CT Insight will be recorded and compared to the true status of the study-cases. The frequency of the scores for each method (Unaided, Aided) 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 one hundred (100) patients whose CT nodules were shown to be cancer and two hundred (200) normal patients. The patient population will be consistent with the national lung cancer screening protocols.
详细描述
A reader study with at least ten (10) participating radiologists will be conducted. A localized receiver operating characteristic curve will be used to evaluate radiologists' diagnostic performance (in terms of the trade-off between the sensitivity and specificity when the decision criteria changes) in the detection of lung nodules on lung CTs with and without the usage of the ClearRead CT Insight (CRCTI) system. The time needed for the review and interpretation of each case will also be recorded.
An initial (baseline) interpretation will be made by each of the radiologists based on the Lung CT in its original form. At a minimum of one month later, each radiologists will again interpret the same images viewing the pair of CRCTI CT series: Two sets of CT images (standard with CADe marks and processed with vessel suppression will be presented on either one large monitor or two adjacent monitors.
During the baseline reading the radiologist will mark the location of the actionable nodules and assign a score. The radiologist will also indicate the recommended method of follow-up (Contrast CT, PET-CT, CT Follow-up, Biopsy).
During the second reading session (concurrent read), the radiologist will be presented with a standard appearing CT with computer-aided detection (CADe) marks placed and the vessel suppressed same slice with the vessel suppressed view (right image). The second image, vessel suppressed, will be grayed out until the radiologist move the mouse to the second panel. The radiologist will mark locations. These may or may not correspond to the locations of the CAD markers. As before, the radiologist will assign a level of suspicious to each mark and indicate the need, if any, of an additional diagnostic action (CT Follow-up, Contrast CT, PET-CT, or Biopsy).
Based on the levels of suspicion for each nodule and the associated likelihood ratings, LROC curves will be constructed for both the baseline and the concurrent reads and the significance of any difference will be calculated. The recommendations for further action (CT Follow-up, Contrast CT, PET-CT, or Biopsy) will be used to calculate sensitivity and specificity, PPV and NPV.
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
- •A thoracic CT case that is associated or with a feature of the following:
- •Asymptomatic patients age 55 - 77 with history of smoking
- •Primary Lung Cancer
- •Biopsy Proven (LuRADS 5) with radiology report
- •Screen detected event plus 1 prior CT. 2 year of prior CTs is preferred, if available.
- •<= 3mm slice spacing, no gaps
- •Use standard reconstruction kernels
- •Maximum of 5 nodules per image
- •Nodules must be 5-20mm in size
- •With or without contrast
排除标准
- •Thoracic CT cases that meet the following exclusion criteria will not be collected for use during clinical testing.
- •No Acute pneumothorax
- •Both lungs must be fully visible within the field of view
- •Apices cannot be cropped
- •No excessive motion 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: 4 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 ClearRead CT software) studies.
Comparing LROC Curve in the Detection of Clinically Actionable Lung Nodules Among Normal
时间窗: 4 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 ClearRead CT software).
次要结局
- Average Reading Time Per Case(4 months)
研究者
ShihChung Ben Lo
Adjunct Professor
Virginia Polytechnic Institute and State University