A Clinical Study of LUNG-CT CAD Decision Support

Lung Cancer Clinical Trial

Official title:

A Clinical Study of LUNG-CT CAD Decision Support

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05230563
• Other study ID #: TaiHao LUNG-CTCAD CCH 210129
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 19, 2021
• Est. completion date: May 31, 2022

Study information

• Verified date: February 2022
• Source: TaiHao Medical Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 8
• Est. completion date: May 31, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 89 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Diseases

Intervention

Device:
• Ti-LUNG
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.

Locations

Country	Name	City	State
Taiwan	Changhua Christian Hospital	Changhua City	Changhua County

Sponsors (1)

Lead Sponsor	Collaborator
TaiHao Medical Inc.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Sensitivity	True Positive / True Positive + False Negative	4 months
Secondary	Specificity	True Negative / False Positive + True Negative	4 months
Secondary	Interpretation time	Reading Time of clinicians	4 months