Clinical trial NCT05230563: A Clinical Study of LUNG-CT CAD Decision Support
Official title: A Clinical Study of LUNG-CT CAD Decision Support
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Cancer
Lung Diseases
Lead sponsor: TaiHao Medical Inc.
Sponsor class: INDUSTRY
First posted: 2022-02-09
Enrollment: 8
Sex: ALL
Minimum age (years): 20
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

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.


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.

Primary outcomes:
measure: Area under the ROC Curve(AUC)
timeFrame: 4 months
Secondary outcomes:
measure: Sensitivity
timeFrame: 4 months
measure: Specificity
timeFrame: 4 months
measure: Interpretation time
timeFrame: 4 months
Other outcomes:
Locations:
city: Changhua City
country: Taiwan
facility: Changhua Christian Hospital
state: Changhua County
Study officials:
affiliation: Study Director
name: Rong Tai Chen, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: