NCT06230419

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
208

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 8, 2024

Completed
22 days until next milestone

First Posted

Study publicly available on registry

January 30, 2024

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2024

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

January 30, 2024

Status Verified

January 1, 2024

Enrollment Period

6 months

First QC Date

January 8, 2024

Last Update Submit

January 29, 2024

Conditions

Keywords

Artificial IntelligenceComputed Tomography

Outcome Measures

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.

    1 months

Secondary Outcomes (1)

  • The evaluations from professionals for outcomes produced by AIs

    1 months

Study Arms (1)

The cerebral trauma group

Eligibility Criteria

Age16 Years - 92 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brain Injury Center, Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, 201114, China

Location

Related Publications (1)

  • Zhang D, Ma Z, Gong R, Lian L, Li Y, He Z, Han Y, Hui J, Huang J, Jiang J, Weng W, Feng J. Using Natural Language Processing (GPT-4) for Computed Tomography Image Analysis of Cerebral Hemorrhages in Radiology: Retrospective Analysis. J Med Internet Res. 2024 Sep 26;26:e58741. doi: 10.2196/58741.

MeSH Terms

Conditions

Cerebral Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Brain Injury Center

Study Record Dates

First Submitted

January 8, 2024

First Posted

January 30, 2024

Study Start

September 1, 2023

Primary Completion

February 15, 2024

Study Completion

March 1, 2024

Last Updated

January 30, 2024

Record last verified: 2024-01

Locations