Trauma, BrainRADIOMIC-TBINCT04058379
Artificial Intelligence Analysis of Initial Scan Evolution of Traumatic Brain Injured Patient to Predict Neurological Outcome
A study testing CT scan in people with Trauma, Brain, run by University Hospital, Grenoble at 1 site in France.
Trial summary
We assume that an early iterative automatic CT scan analysis (D0, D1 and D3) by different AI approaches will allow an early differentiation of the tissues evolution after TBI. Our objective is to couple theses scan profiles to a neurological evolution, measured by therapeutic intensity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trauma, Brain
- What is being tested?
- CT scan
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2020to 12 Oct 2021
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > or = 18 years old
- Closed TBI
- Primary admission in Grenoble University Hospital
- Initial CT scan with visible cerebral lesion rated at least 3 on abbreviated injury score (AIS)
- In ICU for an expected length of 48 hours
- Social security system affiliation
Who cannot join
- Life expectation <48 hours
- In ICU for more than 24h
- Transferred from another hospital
- Patients corresponding to articles L1121-5, L1121-6, L1121-7, L1121-8 (under legal protection) of French Public Health Code
- Patient in exclusion time of another study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Artificial Intelligence Analysis of Initial Scan Evolution of Traumatic Brain Injured Patient to Predict Neurological Outcome: Pilot Translational an Exploratory Study
We assume that an early iterative automatic CT scan analysis (D0, D1 and D3) by different AI approaches will allow an early differentiation of the tissues evolution after TBI. Our objective is to couple theses scan profiles to a neurological evolution, measured by therapeutic intensity.
Read the detailed description
Traumatic brain injury is a common and serious pathology, responsible of an important morbi-mortality. The TBI can be consider as a complex set of nosological entities of different evolution with difficult early identification whereas the main issue of this pathology depends on prevention and management of the lesions caused by the initial cerebral aggression.
Different evolutionary profiles seems to exist and sometimes coexists: edema evolution, hemorrhagic transformation and/or cerebrospinal fluid (CSF) resorption issues with hydrocephalus apparition.
Currently, there is no Imaging methods that can be used in every day clinical management that allows a visualization, quantification and prediction of these different lesional evolutions
CT scan is the reference imaging method for TBI patient monitoring. It allows a lesion description, a therapeutic adaptation and an evaluation of the prognostic.
Even if it is used as a routine examination, the analysis of cerebral scanners remains manual and a non-quantitative one, which make a little informative analysis as far as lesions evolution is concerned.
Recently it has been established the automatic MRI analysis with AI approach allows:
- - To show aspects of images that can't be seen to the naked eye
- - To automatically segment and quantify the different tissues (edema, hemorrhage...). First tests on this kind of analysis on CT scans shows that this technology can be transferred from MRI to CT scans and more importantly it brings out new quantitative informations on cerebral lesions evolution.
- Conditions
- Trauma, Brain
- Being tested
- CT scan
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT scanRadiation
3 ct scans : D0, D1 and D3
| Study group | Role | What they receive |
|---|---|---|
| CT scan | Experimental | During this study each patient will have 3 CT scans : D0, D1 and D3. A daily follow up during first seven days in ICU, then a follow up at D28 if still in hospital, and a phone call at M6 for neurological outcome Receives: Radiation: CT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical evolution during first 7 days in ICU with therapeutic intensity level (TILsum)
Composite criteria : Head position, depth, sort and objective of sedation, presence or absence of a CSF draining system, management of ventilation, presence or absence of a hyperosmolar therapy, management of body temperature, surgical intervention for intracranial hypertension.
Measured: 7 days after TBI
Secondary outcomes (8)
Mortality according to scan profiles
Measured: 28 days after TBI and 6 month after TBI
Morbidity (consequences of the trauma) according to scan profiles
Lenght of stay in ICU with more than 20 mmHg of intracranial pressure with no stimulation
Measured: 28 days after TBI
Morbidity (consequences of the trauma) according to scan profiles
length of stay in ICU with a therapeutic intensity level > or = 8,
Measured: 28 days after TBI
Morbidity (consequences of the trauma) according to scan profiles
Hospital stay length
Measured: 28 days after TBI
Morbidity (consequences of the trauma) according to scan profiles
ICU stay length days with mechanical ventilation
Measured: 28 days after TBI
Morbidity (consequences of the trauma) according to scan profiles
Glasgow Outcome Scale (GOSe)
Measured: 6 months after TBI
Comparison and Description of correlation between early scan profiles evolution signature by AI and to clinical evolution (with TILSum)
Analysis of main outcome (TIL sum after 7 days in ICU maximum) according to a kinetic scan evolution between D0, D1 and D3
Measured: 7 days after TBI
Neurological Pupil Index
Measure of neurological pupilla index within 1h after admission and at D1
Measured: 1 day after TBI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2019
- Study start1 Jan 2020
- Primary completion12 Apr 2021
- Study completion12 Oct 2021 (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 Trauma, BrainStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre BOUZAT, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04058379
- Sponsor's protocol ID
- 38RC19.193
- Acronym
- RADIOMIC-TBI
- Status last verified
- Nov 2020
- First submitted
- 15 Jul 2019
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brossard C, Greze J, de Busschere JA, Attye A, Richard M, Tornior FD, Acquitter C, Payen JF, Barbier EL, Bouzat P, Lemasson B. Prediction of therapeutic intensity level from automatic multiclass segmentation of traumatic brain injury lesions on CT-scans. Sci Rep. 2023 Nov 17;13(1):20155. doi: 10.1038/s41598-023-46945-9.
PubMed 37978266
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence Analysis of Initial Scan Evolution of Traumatic Brain Injured Patient to Predict Neurological Outcome: Pilot Translational an Exploratory Study
- ClinicalTrials.gov ID
- NCT04058379
- Acronym / sponsor ID
- RADIOMIC-TBI / 38RC19.193
- Conditions
- Trauma, Brain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 12 Apr 2021 (actual)
- Study completion
- 12 Oct 2021 (estimated)
- First posted
- 15 Aug 2019 (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.
We assume that an early iterative automatic CT scan analysis (D0, D1 and D3) by different AI approaches will allow an early differentiation of the tissues evolution after TBI. Our objective is to couple theses scan profiles to a neurological evolution, measured by therapeutic intensity.
Detailed description
Traumatic brain injury is a common and serious pathology, responsible of an important morbi-mortality. The TBI can be consider as a complex set of nosological entities of different evolution with difficult early identification whereas the main issue of this pathology depends on prevention and management of the lesions caused by the initial cerebral aggression.
Different evolutionary profiles seems to exist and sometimes coexists: edema evolution, hemorrhagic transformation and/or cerebrospinal fluid (CSF) resorption issues with hydrocephalus apparition.
Currently, there is no Imaging methods that can be used in every day clinical management that allows a visualization, quantification and prediction of these different lesional evolutions
CT scan is the reference imaging method for TBI patient monitoring. It allows a lesion description, a therapeutic adaptation and an evaluation of the prognostic.
Even if it is used as a routine examination, the analysis of cerebral scanners remains manual and a non-quantitative one, which make a little informative analysis as far as lesions evolution is concerned.
Recently it has been established the automatic MRI analysis with AI approach allows:
- - To show aspects of images that can't be seen to the naked eye
- - To automatically segment and quantify the different tissues (edema, hemorrhage...). First tests on this kind of analysis on CT scans shows that this technology can be transferred from MRI to CT scans and more importantly it brings out new quantitative informations on cerebral lesions evolution.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CT scan | Experimental | Radiation: CT scanDuring this study each patient will have 3 CT scans : D0, D1 and D3. A daily follow up during first seven days in ICU, then a follow up at D28 if still in hospital, and a phone call at M6 for neurological outcome |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age > or = 18 years old
- Closed TBI
- Primary admission in Grenoble University Hospital
- Initial CT scan with visible cerebral lesion rated at least 3 on abbreviated injury score (AIS)
- In ICU for an expected length of 48 hours
Key exclusion criteria (5 listed)
- Life expectation <48 hours
- In ICU for more than 24h
- Transferred from another hospital
- Patients corresponding to articles L1121-5, L1121-6, L1121-7, L1121-8 (under legal protection) of French Public Health Code
- Patient in exclusion time of another study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT scan3 ct scans : D0, D1 and D3 | Radiation | CT scan |
Primary outcome
Clinical evolution during first 7 days in ICU with therapeutic intensity level (TILsum)
Time frame: 7 days after TBI
Composite criteria : Head position, depth, sort and objective of sedation, presence or absence of a CSF draining system, management of ventilation, presence or absence of a hyperosmolar therapy, management of body temperature, surgical intervention for intracranial hypertension.
8 secondary outcomes
Mortality according to scan profiles
Time frame: 28 days after TBI and 6 month after TBI
Morbidity (consequences of the trauma) according to scan profiles
Time frame: 28 days after TBI
Morbidity (consequences of the trauma) according to scan profiles
Time frame: 28 days after TBI
Morbidity (consequences of the trauma) according to scan profiles
Time frame: 28 days after TBI
Morbidity (consequences of the trauma) according to scan profiles
Time frame: 28 days after TBI
Morbidity (consequences of the trauma) according to scan profiles
Time frame: 6 months after TBI
Comparison and Description of correlation between early scan profiles evolution signature by AI and to clinical evolution (with TILSum)
Time frame: 7 days after TBI
Neurological Pupil Index
Time frame: 1 day after TBI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Derived from this study: PubMed 37978266Brossard C, Greze J, de Busschere JA, Attye A, Richard M, Tornior FD, Acquitter C, Payen JF, Barbier EL, Bouzat P, Lemasson B. Prediction of therapeutic intensity level from automatic multiclass segmentation of traumatic brain injury lesions on CT-scans. Sci Rep. 2023 Nov 17;13(1):20155. doi: 10.1038/s41598-023-46945-9.
- Individual participant dataSharing planned: No
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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.
Pierre BOUZAT principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT scan in people with Trauma, Brain, run by University Hospital, Grenoble at 1 site in France.
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 6 inclusion and 5 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 28 Apr 2021. 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 France. 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?
Clinical evolution during first 7 days in ICU with therapeutic intensity level (TILsum) (time frame: 7 days after TBI). 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 NCT04058379, 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 28 Apr 2021.