A Clinical Study of LUNG-CT CAD Decision Support

Sponsor
TaiHao Medical Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT05230563
Collaborator
(none)
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Ti-LUNG
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
8 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
A Clinical Study of LUNG-CT CAD Decision Support
Actual Study Start Date :
Aug 19, 2021
Anticipated Primary Completion Date :
May 31, 2022
Anticipated Study Completion Date :
May 31, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Sensitivity [4 months]

    True Positive / True Positive + False Negative

  2. Specificity [4 months]

    True Negative / False Positive + True Negative

  3. Interpretation time [4 months]

    Reading Time of clinicians

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 89 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Changhua Christian Hospital Changhua City Changhua County Taiwan 500209

Sponsors and Collaborators

  • TaiHao Medical Inc.

Investigators

  • Principal Investigator: Rong Tai Chen, Ph.D, Study Director

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
TaiHao Medical Inc.
ClinicalTrials.gov Identifier:
NCT05230563
Other Study ID Numbers:
  • TaiHao LUNG-CTCAD CCH 210129
First Posted:
Feb 9, 2022
Last Update Posted:
Feb 9, 2022
Last Verified:
Feb 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 9, 2022