A Clinical Study of LUNG-CT CAD Decision Support

Not Applicable

• Conditions: Lung Cancer; Lung Diseases
• Interventions: Device: Ti-LUNG

• Registration Number: NCT05230563
• Lead Sponsor: TaiHao Medical Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-19
• Study First Submitted: 2022-01-14
• Status Verified: 2022-02
• Study First Submitted QC: 2022-02-08
• Last Update Submitted: 2022-02-08
• Study First Posted: 2022-02-09
• Last Update Posted: 2022-02-09
• Primary Completion: 2022-05-31
• Study Completion: 2022-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

• Cases of men or women aged between 20 and 89.
• At Changhua Christian Hospital or Yuanlin Christian Hospital, expert (qualified for interpretation of chest computed tomography lung nodules) confirms that the original low-dose computed tomography image had pulmonary nodules (part solid nodule, solid nodule, and pulmonary nodules greater than or equal to 3 mm), and verified that it is as a true nodule through follow-up clinical imaging examination or clinical determination, or
• At Changhua Christian Hospital or Yuanlin Christian Hospital, the subject has undergone a low-dose lung computed tomography and a physician (qualified for interpretation of chest computed tomography lung nodules) confirmed that there are no lung nodules on the computed tomography scan.

Exclusion Criteria

• The computerized tomography of the lungs and obvious administrative or technical errors.
• A physician (qualified for interpretation of chest CT pulmonary nodules) confirms cases with severe infections such as tuberculosis and pneumonia from source report or other medical records.
• A physician (qualified for interpretation of chest CT pulmonary nodules) confirms cases with lung fibrosis such as pneumoconiosis from source report or other medical records.
• Test cases used when training physicians to use the lung computer tomography decision support system.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Experimental Group - with the aid of "Taihao" lung CT decision support system	Ti-LUNG	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

Primary Outcome Measures

Name	Time	Method
Area under the ROC Curve(AUC)	4 months	The primary outcome measure is the area under the receiver operating characteristic (ROC) curve of the radiologists, also known as c statistic.

Secondary Outcome Measures

Name	Time	Method
Sensitivity	4 months	True Positive / True Positive + False Negative
Specificity	4 months	True Negative / False Positive + True Negative
Interpretation time	4 months	Reading Time of clinicians

Trial Locations

Locations (1)

Changhua Christian Hospital; 🇨🇳 Changhua City, Changhua County, Taiwan