Retrospective Study on the Direction of Artificial Intelligence in Identifying Cranial Trauma CT Imaging

Cerebral Hemorrhage Clinical Trial

Official title:

Evaluation of Artificial Intelligence's Ability to Analyze and Recognize Cranial Trauma CT Imaging

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06230419
• Other study ID #: 83760142
• Status: Active, not recruiting
• Start date: September 1, 2023
• Est. completion date: March 1, 2024

Study information

• Verified date: January 2024
• Source: RenJi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal of this observational retrospective study is to evaluate artificial intelligences (AI)'s proficiency in identifying and annotating brain bleeds in computed tomography (CT) images.

The main questions it aims to answer are:

• Whether AIs at present are capable of analyzing and recognizing cerebral traumas in CT images?

• If they are, how competent are they and how can humans take advantages of that? CT images were selected during the normal diagnosis and treatment process of patients, and no one needed to undergo any additional procedures connected to the study.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 208
• Est. completion date: March 1, 2024
• Est. primary completion date: February 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 92 Years

Eligibility

Inclusion Criteria:

• People who had cerebral traumas with brain bleedings shown in CT images.

Exclusion Criteria:

• Brain bleedings were not clear or representative in CT images.

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage

Locations

Country	Name	City	State
China	Brain Injury Center, Renji Hospital, School of Medicine, Shanghai Jiao Tong University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The identification completeness of the annotated images.	Use Photoshop to calculate the area of hemorrhage and the marked area, and then computing the ratio, import into Graphpad Prism for further analysis of the mean percentage and the standard deviation.	1 months
Secondary	The evaluations from professionals for outcomes produced by AIs	The outputs will be evaluated by professional radiologists on a 4-point scale questionnaire from the completeness, accuracy and success of the annotation. Then the results of the questionnaire will be further analyzed in the Graphpad Prism to get the average score and the standard deviation.	1 months