Back to resultsA Clinical Study of LUNG-CT CAD Decision Support
Primary Purpose
Lung Cancer, Lung Diseases
Status
Active
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Ti-LUNG
Sponsored by
About this trial
This is an interventional diagnostic trial for Lung Cancer
Eligibility Criteria
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.
Sites / Locations
- Changhua Christian Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control Group
Experimental Group - with the aid of "Taihao" lung CT decision support system
Arm Description
Participating clinicians will perform lung nodule detection on 200 cases of lung low-dose computed tomography images
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Sensitivity
True Positive / True Positive + False Negative
Specificity
True Negative / False Positive + True Negative
Interpretation time
Reading Time of clinicians
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05230563
Brief Title
A Clinical Study of LUNG-CT CAD Decision Support
Official Title
A Clinical Study of LUNG-CT CAD Decision Support
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 19, 2021 (Actual)
Primary Completion Date
May 31, 2022 (Anticipated)
Study Completion Date
May 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TaiHao Medical Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Lung Diseases
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Participating clinicians will perform lung nodule detection on 200 cases of lung low-dose computed tomography images
Arm Title
Experimental Group - with the aid of "Taihao" lung CT decision support system
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Ti-LUNG
Intervention Description
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.
Primary Outcome Measure Information:
Title
Area under the ROC Curve(AUC)
Description
The primary outcome measure is the area under the receiver operating characteristic (ROC) curve of the radiologists, also known as c statistic.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Sensitivity
Description
True Positive / True Positive + False Negative
Time Frame
4 months
Title
Specificity
Description
True Negative / False Positive + True Negative
Time Frame
4 months
Title
Interpretation time
Description
Reading Time of clinicians
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rong Tai Chen, Ph.D
Organizational Affiliation
Study Director
Official's Role
Principal Investigator
Facility Information:
Facility Name
Changhua Christian Hospital
City
Changhua City
State/Province
Changhua County
ZIP/Postal Code
500209
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
A Clinical Study of LUNG-CT CAD Decision Support
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