None listed
Conditions
Interventions
Medical Device : When the reference standard construction is completed as many as the number of target image providers, only images that meet all selection/exclusion criteria are randomly assigned to
Sponsors
Seoul National University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All of the following selection criteria must be satisfied to participate in this clinical trial. 1. Non-contrast brain CT images of men and women aged 19 years or older 2. Brain CT images taken in the axial direction for suspected acute cerebral infarction or for examination 3. Clinical information of the image provider* and (in the case of the data of the image provider diagnosed as benign) Brain CT image that can obtain a brain MRI image (DWI)** *Date of birth (or age as of date of CT scan), date of CT scan, gender, name of CT device used **Brain MRI image (DWI) taken within about 3 hours after brain CT scan 4. Images with a score of 3 or higher on the image quality questionnaire (refer to the image quality questionnaire standard table) Image quality questionnaire standard table Based on 5-point scale 1 Non diagnostic due to excessive noise or artifacts 2 Diagnosis questionable due to excessive noise or artifacts, moderate decrease in confidence 3 Diagnostic with moderate but acceptable noise or artifacts 4 Mild noise, no change in confidence 5 Routine diagnostic image quality 5. (Selection Criteria after Reference Standard Establishment) As a result of reference standard establishment, images constructed as positive (acute cerebral infarction ‘yes’) or negative (acute cerebral infarction ‘no’)
Exclusion criteria
Exclusion criteria: If any of the following exclusion criteria are met, the subject cannot participate in this clinical trial. 1. Brain CT imaging using contrast agent 2. Cerebral hemorrhage confirmed on brain CT image 3. Brain CT images already used as a training set or validation set for clinical trial medical device development 4. (Exclusion criteria after establishment of reference standard) If positive (acute cerebral infarction ‘yes’) or negative (acute cerebral infarction ‘no’) images are collected as many as the target number of image providers and additional registration is not required 5. If the trial director determines that participation in a clinical trial is inappropriate due to an impact on the efficacy evaluation result or for other reasons (specific reasons are recorded in the case report)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical Sensitivity for diagnosis of image provider (%), Clinical Specificity for diagnosis of image provider (%) | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical Accuracy for diagnosis of image provider (%), Clinical Sensitivity considering location of acute cerebral infarction (%), Concordance rate of intra-group image reading results, Clinical Sensitivity for CT image slice reading (%), Clinical Specificity for CT image slice reading (%), Clinical Accuracy for CT image slice reading (%);Sensitivity (%) of the acute cerebral infarction determination algorithm of clinical trial medical devices, specificity (%) of the acute cerebral infarction determination algorithm of clinical trial medical devices, Accuracy (%), positive predictive value (%), negative predictive value (%) for acute cerebral infarction determination algorithm of clinical trial medical device, AUC of ROC Curve (Area Under the Curve of Receiver Operating Characteristic Curve) for acute cerebral infarction determination algorithm of clinical trial medical device, processing time for acute cerebral infarction determination algorithm of clinical trial medical device (sec) | — |
Countries
Korea, Republic of
Contacts
Public ContactTae Jin Yun
Seoul National University Hospital
Outcome results
None listed