A Clinical Study of LUNG-CT CAD Decision Support

NCT05230563 | Unknown

• 1 other identifier: TaiHao LUNG-CTCAD CCH 210129
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer; Lung Diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Sensitivity

  4 months

• Specificity

  4 months

• Interpretation time

  4 months

Study Arms (2)

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

Device: Ti-LUNG

Interventions

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.

Experimental Group - with the aid of "Taihao" lung CT decision support system

Eligibility Criteria

• Age: 20 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• TaiHao Medical Inc.: lead

Study Sites (1)

Changhua Christian Hospital

Changhua, Changhua County, 500209, Taiwan

Location

MeSH Terms

Conditions

Lung Neoplasms; Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Respiratory Tract Diseases

Study Officials

• Rong Tai Chen, Ph.D

  Study Director

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2022
• First Posted: February 9, 2022
• Study Start: August 19, 2021
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: February 9, 2022

Record last verified: 2022-02

Locations

TW (1)