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

Primary Purpose

Trauma, Brain

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
CT scan
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Trauma, Brain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University Hospital Grenoble

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CT scan

Arm 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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Mortality according to scan profiles
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
Morbidity (consequences of the trauma) according to scan profiles
length of stay in ICU with a therapeutic intensity level > or = 8,
Morbidity (consequences of the trauma) according to scan profiles
Hospital stay length
Morbidity (consequences of the trauma) according to scan profiles
ICU stay length days with mechanical ventilation
Morbidity (consequences of the trauma) according to scan profiles
Glasgow Outcome Scale (GOSe)
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
Neurological Pupil Index
Measure of neurological pupilla index within 1h after admission and at D1

Full Information

First Posted
July 15, 2019
Last Updated
April 27, 2021
Sponsor
University Hospital, Grenoble
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1. Study Identification

Unique Protocol Identification Number
NCT04058379
Brief Title
Artificial Intelligence Analysis of Initial Scan Evolution of Traumatic Brain Injured Patient to Predict Neurological Outcome
Acronym
RADIOMIC-TBI
Official Title
Artificial Intelligence Analysis of Initial Scan Evolution of Traumatic Brain Injured Patient to Predict Neurological Outcome: Pilot Translational an Exploratory Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
April 12, 2021 (Actual)
Study Completion Date
October 12, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trauma, Brain

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CT scan
Arm Type
Experimental
Arm 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
Intervention Type
Radiation
Intervention Name(s)
CT scan
Intervention Description
3 ct scans : D0, D1 and D3
Primary Outcome Measure Information:
Title
Clinical evolution during first 7 days in ICU with therapeutic intensity level (TILsum)
Description
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.
Time Frame
7 days after TBI
Secondary Outcome Measure Information:
Title
Mortality according to scan profiles
Time Frame
28 days after TBI and 6 month after TBI
Title
Morbidity (consequences of the trauma) according to scan profiles
Description
Lenght of stay in ICU with more than 20 mmHg of intracranial pressure with no stimulation
Time Frame
28 days after TBI
Title
Morbidity (consequences of the trauma) according to scan profiles
Description
length of stay in ICU with a therapeutic intensity level > or = 8,
Time Frame
28 days after TBI
Title
Morbidity (consequences of the trauma) according to scan profiles
Description
Hospital stay length
Time Frame
28 days after TBI
Title
Morbidity (consequences of the trauma) according to scan profiles
Description
ICU stay length days with mechanical ventilation
Time Frame
28 days after TBI
Title
Morbidity (consequences of the trauma) according to scan profiles
Description
Glasgow Outcome Scale (GOSe)
Time Frame
6 months after TBI
Title
Comparison and Description of correlation between early scan profiles evolution signature by AI and to clinical evolution (with TILSum)
Description
Analysis of main outcome (TIL sum after 7 days in ICU maximum) according to a kinetic scan evolution between D0, D1 and D3
Time Frame
7 days after TBI
Title
Neurological Pupil Index
Description
Measure of neurological pupilla index within 1h after admission and at D1
Time Frame
1 day after TBI

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre BOUZAT
Organizational Affiliation
University Hospital, Grenoble
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Grenoble
City
Grenoble
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Artificial Intelligence Analysis of Initial Scan Evolution of Traumatic Brain Injured Patient to Predict Neurological Outcome

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