Cerebral HemorrhageNCT06230419
Retrospective Study on the Direction of Artificial Intelligence in Identifying Cranial Trauma CT Imaging
An observational study of Cerebral Hemorrhage, run by RenJi Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 16 to 92 years
- Conditions the study is for
- Cerebral Hemorrhage
- How many people
- 208 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2023to 1 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 92 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population ranges from 16 years old to 92 years old, both female and male, who mostly are the elderly.
Who may be able to join
- People who had cerebral traumas with brain bleedings shown in CT images.
Who cannot join
- Brain bleedings were not clear or representative in CT images.
Trial locations and contacts
1 site in 1 country.
China1 site
Brain Injury Center, Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 201114
About this study
Official title: Evaluation of Artificial Intelligence's Ability to Analyze and Recognize Cranial Trauma CT Imaging
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.
- Conditions
- Cerebral Hemorrhage
- Keywords
- Artificial Intelligence, Computed Tomography
- Medical subject headings
- Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| The cerebral trauma group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start1 Sep 2023
- Primary completion15 Feb 2024 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral HemorrhageStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Junfeng Feng, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06230419
- Sponsor's protocol ID
- 83760142
- Status last verified
- Jan 2024
- First submitted
- 8 Jan 2024
- Last updated
- 30 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39326037
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Artificial Intelligence's Ability to Analyze and Recognize Cranial Trauma CT Imaging
- ClinicalTrials.gov ID
- NCT06230419
- Acronym / sponsor ID
- 83760142
- Conditions
- Cerebral Hemorrhage
- Keywords
- Artificial Intelligence, Computed Tomography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 208 participants (actual)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 15 Feb 2024 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 30 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The cerebral trauma group | – | – |
Who may qualify
- Ages
- 16 to 92 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population ranges from 16 years old to 92 years old, both female and male, who mostly are the elderly.
Key inclusion criteria (1 listed)
- People who had cerebral traumas with brain bleedings shown in CT images.
Key exclusion criteria (1 listed)
- Brain bleedings were not clear or representative in CT images.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The identification completeness of the annotated images.
Time frame: 1 months
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 secondary outcome
The evaluations from professionals for outcomes produced by AIs
Time frame: 1 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- Derived from this study: PubMed 39326037Zhang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Hemorrhage, run by RenJi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The identification completeness of the annotated images. (time frame: 1 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06230419, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2024.