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Comparison of Image Quality Between Ultra-low Dose (ULD) and Standard Dose CT Scans in Detecting Traumatic Brain Injury in the Emergency Room (ULD-CRANE 2)

Primary Purpose

Closed Head Injury, Penetrating Head Injury

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
CT scan
Sponsored by
Centre Hospitalier Universitaire de Nīmes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Closed Head Injury

Eligibility Criteria

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

Inclusion Criteria:

  • Patient presenting to the emergency room of the CHU of Nîmes for a cranial trauma requiring scanning.
  • Patient with isolated head injury or polytrauma patient with head injury among others.
  • The patient or their legal representative or family member must have given their free and informed consent and signed the consent form, or the patient was included under an emergency situation
  • The patient must be a member or beneficiary of a health insurance plan

Exclusion Criteria:

  • The subject is participating in a study prohibiting participation in other studies, or is in a period of exclusion determined by a previous study
  • Patient is pregnant, parturient or breastfeeding

Sites / Locations

  • CHU de Nimes

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with head trauma

Arm Description

Outcomes

Primary Outcome Measures

Image quality of ultra-low dose scan compared to classic dose for visualising the differentiation of grey/white matter
5-point scale: unacceptable, sub-optimal, acceptable, better than average
Image quality of ultra-low dose scan compared to classic dose for visualising lenticular nuclei
5-point scale: unacceptable, sub-optimal, acceptable, better than average
Image quality of ultra-low dose scan compared to classic dose for visualising the ventricular system
5-point scale: unacceptable, sub-optimal, acceptable, better than average
Image quality of ultra-low dose scan compared to classic dose for visualising basal cisterns
5-point scale: unacceptable, sub-optimal, acceptable, better than average
Image quality of ultra-low dose scan compared to classic dose for visualising deconvexed subarachnoid spaces
5-point scale: unacceptable, sub-optimal, acceptable, better than average

Secondary Outcome Measures

Inter-evaluator concordance (senior versus junior) in visualizing all five structures (differentiation of grey/white matter, lenticular nuclei, ventricular system, basal cisterns, deconvexed subarachnoid spaces)
Total score of the 5 Likert scores
Presence of at least one extradural hematoma by ultra-low dose versus classical scanner
Yes/no
Presence of at least one subarachnoid hemorrhage by ultra-low dose versus classical scanner
Yes/no
Presence of at least one subdural hematoma by ultra-low dose versus classical scanner
Yes/no
Presence of at least one intraparenchymal hemorrhage by ultra-low dose versus classical scanner
Yes/no
Presence of at least one intracranial hemorrhage by ultra-low dose versus classical scanner
Yes/no
Presence of at least one cranial bone lesion by ultra-low dose versus classical scanner
Yes/no
Presence of at least one bone lesion by ultra-low dose versus classical scanner
Yes/no
Radiologist-reported image quality of ultra-low dose versus classical scanner
4-point Likert scale: Interpretable, interpretable despite moderate technical issues (centering, movement, constant), entirely interpretable despite moderate technical issues (centering, movement, constant), No technical issues
Radiologist-reported diagnostic quality of ultra-low dose versus classical scanner
4-point Likert scale: unacceptable, sub-optimal, acceptable, better than average
Radiologist-reported confidence level of ultra-low dose versus classical scanner
4-point Likert scale: unacceptable, sub-optimal, acceptable, better than average
Interpretation time of ultra-low dose versus classical scanner for a senior and junior evaluator
Minutes

Full Information

First Posted
January 14, 2022
Last Updated
January 14, 2022
Sponsor
Centre Hospitalier Universitaire de Nīmes
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1. Study Identification

Unique Protocol Identification Number
NCT05210855
Brief Title
Comparison of Image Quality Between Ultra-low Dose (ULD) and Standard Dose CT Scans in Detecting Traumatic Brain Injury in the Emergency Room
Acronym
ULD-CRANE 2
Official Title
Comparison of Image Quality Between Ultra-low Dose (ULD) and Standard Dose CT Scans in Detecting Traumatic Brain Injury in the Emergency Room
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 2022 (Anticipated)
Primary Completion Date
September 2022 (Anticipated)
Study Completion Date
September 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Head trauma is a frequent reason for consultation in the emergency room. The CT scan is the reference examination allowing rapid management of the patient. However, CT examinations are among the diagnostic examinations with the highest exposure to ionizing radiation. The study investigators have previously implemented "ultra-low dose" (ULD) acquisitions for several pathologies with an effective dose level similar to that of a standard radiographic examination. These ULD acquisitions are now routinely used in our clinical practice for explorations of the thorax, spine, pelvis and proximal femurs, extremities. This study expands these ULD acquisitions to skull CT for detecting traumatic intracranial lesions. The study investigators hypothesize that it would be possible to search for intracranial lesions in patients with head trauma using ULD protocols, thereby reducing the doses delivered to the patient while maintaining sufficient image quality for the diagnosis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Closed Head Injury, Penetrating Head Injury

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
77 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients with head trauma
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
CT scan
Intervention Description
Scan with classic dose followed by ultra-low dose
Primary Outcome Measure Information:
Title
Image quality of ultra-low dose scan compared to classic dose for visualising the differentiation of grey/white matter
Description
5-point scale: unacceptable, sub-optimal, acceptable, better than average
Time Frame
Day 0
Title
Image quality of ultra-low dose scan compared to classic dose for visualising lenticular nuclei
Description
5-point scale: unacceptable, sub-optimal, acceptable, better than average
Time Frame
Day 0
Title
Image quality of ultra-low dose scan compared to classic dose for visualising the ventricular system
Description
5-point scale: unacceptable, sub-optimal, acceptable, better than average
Time Frame
Day 0
Title
Image quality of ultra-low dose scan compared to classic dose for visualising basal cisterns
Description
5-point scale: unacceptable, sub-optimal, acceptable, better than average
Time Frame
Day 0
Title
Image quality of ultra-low dose scan compared to classic dose for visualising deconvexed subarachnoid spaces
Description
5-point scale: unacceptable, sub-optimal, acceptable, better than average
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
Inter-evaluator concordance (senior versus junior) in visualizing all five structures (differentiation of grey/white matter, lenticular nuclei, ventricular system, basal cisterns, deconvexed subarachnoid spaces)
Description
Total score of the 5 Likert scores
Time Frame
Day 0
Title
Presence of at least one extradural hematoma by ultra-low dose versus classical scanner
Description
Yes/no
Time Frame
Day 0
Title
Presence of at least one subarachnoid hemorrhage by ultra-low dose versus classical scanner
Description
Yes/no
Time Frame
Day 0
Title
Presence of at least one subdural hematoma by ultra-low dose versus classical scanner
Description
Yes/no
Time Frame
Day 0
Title
Presence of at least one intraparenchymal hemorrhage by ultra-low dose versus classical scanner
Description
Yes/no
Time Frame
Day 0
Title
Presence of at least one intracranial hemorrhage by ultra-low dose versus classical scanner
Description
Yes/no
Time Frame
Day 0
Title
Presence of at least one cranial bone lesion by ultra-low dose versus classical scanner
Description
Yes/no
Time Frame
Day 0
Title
Presence of at least one bone lesion by ultra-low dose versus classical scanner
Description
Yes/no
Time Frame
Day 0
Title
Radiologist-reported image quality of ultra-low dose versus classical scanner
Description
4-point Likert scale: Interpretable, interpretable despite moderate technical issues (centering, movement, constant), entirely interpretable despite moderate technical issues (centering, movement, constant), No technical issues
Time Frame
Day 0
Title
Radiologist-reported diagnostic quality of ultra-low dose versus classical scanner
Description
4-point Likert scale: unacceptable, sub-optimal, acceptable, better than average
Time Frame
Day 0
Title
Radiologist-reported confidence level of ultra-low dose versus classical scanner
Description
4-point Likert scale: unacceptable, sub-optimal, acceptable, better than average
Time Frame
Day 0
Title
Interpretation time of ultra-low dose versus classical scanner for a senior and junior evaluator
Description
Minutes
Time Frame
Day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient presenting to the emergency room of the CHU of Nîmes for a cranial trauma requiring scanning. Patient with isolated head injury or polytrauma patient with head injury among others. The patient or their legal representative or family member must have given their free and informed consent and signed the consent form, or the patient was included under an emergency situation The patient must be a member or beneficiary of a health insurance plan Exclusion Criteria: The subject is participating in a study prohibiting participation in other studies, or is in a period of exclusion determined by a previous study Patient is pregnant, parturient or breastfeeding
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Djamel Dabli
Phone
04.66.68.33.10
Email
djamel.dabli@chu-nimes.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolas Menjot de Champfleur
Organizational Affiliation
CHU Nimes
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Nimes
City
Nîmes
Country
France

12. IPD Sharing Statement

Learn more about this trial

Comparison of Image Quality Between Ultra-low Dose (ULD) and Standard Dose CT Scans in Detecting Traumatic Brain Injury in the Emergency Room

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