A Clinical Study of LUNG-CT CAD Decision Support

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Lung Diseases; Lung Cancer
• Intervention / Treatment: Device: Ti-LUNG

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Changhua County
    • Changhua City, Changhua County, Taiwan, 500209
      • Changhua Christian Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; Participating clinicians will perform lung nodule detection on 200 cases of lung low-dose computed tomography images
Experimental: Experimental Group - with the aid of "Taihao" lung CT decision support system; 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	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity	True Positive / True Positive + False Negative	4 months
Specificity	True Negative / False Positive + True Negative	4 months
Interpretation time	Reading Time of clinicians	4 months

Collaborators and Investigators

• Sponsor: TaiHao Medical Inc.
• Investigators: Principal Investigator: Rong Tai Chen, Ph.D, Study Director

Study record dates

Study Major Dates

• Study Start (Actual): August 19, 2021
• Primary Completion (Anticipated): May 31, 2022
• Study Completion (Anticipated): May 31, 2022

Study Registration Dates

• First Submitted: January 14, 2022
• First Submitted That Met QC Criteria: February 8, 2022
• First Posted (Actual): February 9, 2022

Study Record Updates

• Last Update Posted (Actual): February 9, 2022
• Last Update Submitted That Met QC Criteria: February 8, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases
• Other Study ID Numbers: TaiHao LUNG-CTCAD CCH 210129

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No