Artificial Intelligence Analysis of Initial Scan Evolution of Traumatic Brain Injured Patient to Predict Neurological Outcome (RADIOMIC-TBI)

Grenoble Alpes University Hospital Center (CHU)

Status: Unknown

Conditions: Trauma, Brain

Treatments: Radiation: CT scan

Study type: Interventional

Funder types: Other

Identifiers

NCT04058379

38RC19.193

Details and patient eligibility

About

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.

Full 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:

1. • To show aspects of images that can't be seen to the naked eye
2. • 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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 design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

CT scan

Experimental group

Description:

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

Treatment:

Radiation: CT scan