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Active, not recruitingNCT06230419Updated Jan 30, 2024

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

An observational study in Cerebral Hemorrhage, sponsored by RenJi Hospital. Active, not recruiting at 1 site in China. Open to participants aged 16 Years to 92 Years. Per ClinicalTrials.gov, last updated 2024-01-30.

Sponsored by RenJi Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Feb 2024, 2 years 7 months ago, but the record still lists the study as active, not recruiting.
Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
208
Ages
16 Years to 92 Years
Sex
All
01

Study 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.
02

Conditions studied

  • Cerebral Hemorrhage

Keywords

  • Artificial Intelligence
  • Computed Tomography
03

In context

Cerebral Hemorrhage

476 studies on the registry are indexed under Cerebral Hemorrhage; 181 are open to participants now.

This study's enrollment of 208 is below the median of 275 across 180 observational studies indexed under Cerebral Hemorrhage.

Browse Cerebral Hemorrhage studies →

Lead sponsor

RenJi Hospital is the lead sponsor of 535 studies on the registry; 244 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 92 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

The study population ranges from 16 years old to 92 years old, both female and male, who mostly are the elderly.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Brain bleedings were not clear or representative in CT images.
05

Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
208 participants (actual)
Patient registry
No

Groups and cohorts

  • The cerebral trauma group
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 months

Secondary outcomes

  1. 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.

    Time frame: 1 months

07

Study locations

1 site
  • Brain Injury Center, Renji Hospital, School of Medicine, Shanghai Jiao Tong University
    Shanghai, Shanghai 201114, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 30, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06230419
Lead sponsor
RenJi Hospital
Responsible party
Junfeng Feng (Director of Brain Injury Center, RenJi Hospital) — Principal investigator
First posted
Jan 30, 2024
Start date
Sep 1, 2023
Primary completion
Feb 15, 2024 (estimated)
Completion
Mar 1, 2024 (estimated)
Last update
Jan 30, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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