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This product is a computer-aided detection software designed to assist clinicians in detecting lung nodules in chest computer tomography. This product receives from PACS, radiology information system or directly from computer tomography scanner. After receiving the image, the product performs image analysis and provides a mark of suspected lung nodules. Users can use existing medical image capture and transmission systems or reading software to view these annotations on the workstation.
The main purpose of this trial is to verify that when clinicians perform chest CT pulmonary nodule detection, compared to only diagnosis based on chest CT images, whether the "Taihao" lung CT decision support system helps to improve the diagnostic efficiency of clinicians.
The secondary purpose is to evaluate that when clinicians perform chest CT pulmonary nodule detection, compared to only diagnosis based on chest CT images, whether the "Taihao" lung CT decision support system helps to improve the sensitivity, specificity, and image interpretation time (Reading Time) of clinicians.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | No Intervention | Participating clinicians will perform lung nodule detection on 200 cases of lung low-dose computed tomography images | |
| Experimental Group - with the aid of "Taihao" lung CT decision support system | Experimental | Participating clinicians will perform lung nodule detection on 200 cases of lung low-dose computed tomography images with the aid of "Taihao" lung CT decision support system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ti-LUNG | Device | Participating clinicians will perform two image interpretations on all cases. One period the clinicians only will perform lung nodule detection on chest CT images, and the other period will perform lung nodule detection on chest CT images with the aid of "Taihao" lung CT decision support system. In each interpretation, all lung nodule is marked by each radiologist. This test collects chest computerized tomography cases for computer analysis, and evaluates whether the "TaiHao" lung CT decision support system helps doctors make more accurate diagnoses. |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the ROC Curve(AUC) | The primary outcome measure is the area under the receiver operating characteristic (ROC) curve of the radiologists, also known as c statistic. | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity | True Positive / True Positive + False Negative | 4 months |
| Specificity | True Negative / False Positive + True Negative | 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rong Tai Chen, Ph.D | Study Director | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changhua Christian Hospital | Changhua | Changhua County | 500209 | Taiwan |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 12, 2022 | |
| Reset | May 25, 2023 | |
| Release | Jun 14, 2023 | |
| Reset | Feb 14, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 12, 2022 | May 25, 2023 | |||
| Jun 14, 2023 |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D008171 | Lung Diseases |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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|
| Interpretation time | Reading Time of clinicians | 4 months |
| Feb 14, 2024 |
| D012140 |
| Respiratory Tract Diseases |