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Artificial Intellignece-assisted diagnosis of cerebral aneurysms: multi-center, single blinded, prospective study

Status Approved

First Submitted Date

2021/03/22
Registered Date

2021/04/07
Last Updated Date

2021/03/29

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0006065
Unique Protocol ID	2014X21
Public/Brief Title	Artificial Intellignece-assisted diagnosis of cerebral aneurysms
Scientific Title	Artificial Intellignece-assisted diagnosis of cerebral aneurysms: multi-center, single blinded, prospective study
Acronym	AI-CA
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status	Not applicable

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	1-2020-0074
Approval Date	2020-12-20
Institutional Review Board Name	Severance Hospital IRB
Institutional Review Board Address	Yonsei University Health System, 50-1 Yonsei-ro, Seodaemun-gu, Seoul
Institutional Review Board Telephone	02-2228-0500
Data Monitoring Committee	No

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Keun Young Park
Title	Dr.
Telephone	+82-2-2228-2150
Affiliation	Yonsei University
Address	Yonsei University Health System, 50-1 Yonsei-ro, Seodaemun-gu, Seoul
Contact Person for Public Queries
Name	Keun Young Park
Title	Dr.
Telephone	+82-2-2228-2150
Affiliation	Yonsei University
Address	Yonsei University Health System, 50-1 Yonsei-ro, Seodaemun-gu, Seoul
Contact Person for Updating Information
Name	Keun Young Park
Title	Dr.
Telephone	+82-2-2228-2150
Affiliation	Yonsei University
Address	Yonsei University Health System, 50-1 Yonsei-ro, Seodaemun-gu, Seoul

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Multi-center Number of center : 3
Overall Recruitment Status	Not yet recruiting
Date of First Enrollment	2021-04-01 Anticipated
Target Number of Participant	300
Primary Completion Date	2022-02-28 , Anticipated
Study Completion Date	2022-03-31 , Anticipated
Name of Study	Yonsei University Health System, Severance Hospital
Recruitment Status	Not yet recruiting
Date of First Enrollment	2021-04-01 ,
Recruitment Status by Participating Study Site 2
Name of Study	Yonsei University Yongin Severance Hospital
Recruitment Status	Not yet recruiting
Date of First Enrollment	2021-04-01 ,
Recruitment Status by Participating Study Site 3
Name of Study	Ewha Womans University Seoul Hospital
Recruitment Status	Not yet recruiting
Date of First Enrollment	2021-04-01 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	Ministry of Health & Welfare
Organization Type	Government
Project ID	2014X21

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Yonsei University
Organization Type	University

7. Study Summary

Study Summary Information
Lay Summary	Unruptured cerebral aneurysm is a typical cerebrovascular disease found in about 2% of the population. Upon rupture of a cerebral aneurysm, 50 to 60% of patients have death or severe disability. Therefore, early detection and active treatment of cerebral aneurysms is important for public health. On the other hand, brain MR image data for diagnosing a cerebral aneurysm is increasing exponentially, but the number of radiologists specializing in neuroimaging who can accurately read it is limited. As a result, inaccurate readings and time consumption by non-professionals degrade the quality of medical care, and eventually, it remains intact as damage to medical consumers. Therefore, there is a need for brain image processing and decision-making assistance using artificial intelligence for accurate and fast reading of brain MR. This study verifies the effectiveness of the artificial intelligence medical device (DEEP:NEURO-CA-01, Deepnoid Co., Ltd.) approved by the Ministry of Food and Drug Safety in the actual clinical medical field, and secures the improvement and stability of the software. In the end, it aims for the world's first commercialization as an auxiliary software for cerebral aneurysm diagnosis.

Study Summary Information

Lay Summary

Unruptured cerebral aneurysm is a typical cerebrovascular disease found in about 2&#37; of the population. Upon rupture of a cerebral aneurysm, 50 to 60&#37; of patients have death or severe disability. Therefore, early detection and active treatment of cerebral aneurysms is important for public health.
  On the other hand, brain MR image data for diagnosing a cerebral aneurysm is increasing exponentially, but the number of radiologists specializing in neuroimaging who can accurately read it is limited. As a result, inaccurate readings and time consumption by non-professionals degrade the quality of medical care, and eventually, it remains intact as damage to medical consumers. Therefore, there is a need for brain image processing and decision-making assistance using artificial intelligence for accurate and fast reading of brain MR. This study verifies the effectiveness of the artificial intelligence medical device (DEEP:NEURO-CA-01, Deepnoid Co., Ltd.) approved by the Ministry of Food and Drug Safety in the actual clinical medical field, and secures the improvement and stability of the software. In the end, it aims for the world&#39;s first commercialization as an auxiliary software for cerebral aneurysm diagnosis.

8. Study Design

Study Design Information - Study Type, Observational Study Model, Time Perspective, Target Number of Participant, Cohort/Group Number, Cohort/Group, Cohort/Group Label, Cohort/Group Description, Biospecimen Collection & Archiving, Biospecimen Description
Study Type	Observational Study
Observational Study Model	Case-control
Time Perspective	Prospective
Target Number of Participant	300
Cohort/Group Number	1
Cohort/ Group 1	Cohort/Group Label Adult patients with unruptured cerebral aneurysms and normal adults
Cohort/ Group 1	Cohort/Group Description Adults over 19 years of age who visit Severance Hospital, Yongin Severance Hospital, and Ewha Womans University Seoul Hospital Neurosurgery Department. The TOF MRA was collected from the group that agreed to the study, and the results on the presence and location of a cerebral aneurysm, and reading time were collected and compared between the groups that were read using artificial intelligence and those that did not.
Biospecimen Collection & Archiving	Not collect nor Archive
Biospecimen Description

9. Subject Eligibility

Subject Eligibility Information
Study Population Description	Adults over 19 years of age who visit Severance Hospital, Yongin Severance Hospital, and Ewha Womans University Seoul Hospital Neurosurgery Department.
Sampling Method	When the sensitivity is 0.748 in unaided, 0.852 in aided, and the discrepancy rate is 0.325, the minimum number of subjects required is 251, and 300 people will be competitively recruited from three institutions considering 20% dropout.
Condition(s)/Problem(s)	* (I00-I99)Diseases of the circulatory system (I67.1)Cerebral aneurysm, nonruptured Unruptured Cerebral Aneurysm
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 19Year~75Year
	Description ① Adults of Korean nationality aged 19 years or older and under 75 years of age who have undergone cerebrovascular magnetic resonance imaging (MRA). ② MRA is limited to those photographed using the time-of-flight (TOF) technique. ③ The magnetic field strength of the MRA image should be taken at 1.5T or 3T. ④ Cerebral aneurysm is limited to saccular aneurysms. ⑤ When the patient himself/herself consents to this study
Exclusion Criteria	① In case of rupture or deviating from normal anatomical structure due to hematoma ② If a fusiform, detachable, or infectious cerebral aneurysm is suspected ③ If you have already been treated
Healthy Volunteers	Yes

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	Efficacy
Outcome	Improvement of diagnositicperformance of researcher
Timepoint	Within 1 year after the end of research subject selection
Secondary Outcome(s) 1
Outcome	Time spent on researcher's diagnosis
Timepoint	Within 1 year after the end of research subject selection
Secondary Outcome(s) 2
Outcome	Diagnosis performance of artificial intelligence software
Timepoint	Within 1 year after the end of research subject selection

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	No

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