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)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Penetrating Head Injury; Closed Head Injury
• Intervention / Treatment: Diagnostic test: CT scan

• Study Type: Interventional
• Enrollment (Anticipated): 77
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Djamel Dabli; Phone Number: 04.66.68.33.10; Email: djamel.dabli@chu-nimes.fr

Study Locations

• France
  • Nîmes, France
    • CHU de Nîmes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients with head trauma	Diagnostic test: CT scan; Scan with classic dose followed by ultra-low dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Day 0
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	Day 0
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	Day 0
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	Day 0
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	Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Day 0
Presence of at least one extradural hematoma by ultra-low dose versus classical scanner	Yes/no	Day 0
Presence of at least one subarachnoid hemorrhage by ultra-low dose versus classical scanner	Yes/no	Day 0
Presence of at least one subdural hematoma by ultra-low dose versus classical scanner	Yes/no	Day 0
Presence of at least one intraparenchymal hemorrhage by ultra-low dose versus classical scanner	Yes/no	Day 0
Presence of at least one intracranial hemorrhage by ultra-low dose versus classical scanner	Yes/no	Day 0
Presence of at least one cranial bone lesion by ultra-low dose versus classical scanner	Yes/no	Day 0
Presence of at least one bone lesion by ultra-low dose versus classical scanner	Yes/no	Day 0
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	Day 0
Radiologist-reported diagnostic quality of ultra-low dose versus classical scanner	4-point Likert scale: unacceptable, sub-optimal, acceptable, better than average	Day 0
Radiologist-reported confidence level of ultra-low dose versus classical scanner	4-point Likert scale: unacceptable, sub-optimal, acceptable, better than average	Day 0
Interpretation time of ultra-low dose versus classical scanner for a senior and junior evaluator	Minutes	Day 0

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Nicolas Menjot de Champfleur, CHU Nimes

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2022
• Primary Completion (Anticipated): September 1, 2022
• Study Completion (Anticipated): September 1, 2022

Study Registration Dates

• First Submitted: January 14, 2022
• First Submitted That Met QC Criteria: January 14, 2022
• First Posted (Actual): January 27, 2022

Study Record Updates

• Last Update Posted (Actual): January 27, 2022
• Last Update Submitted That Met QC Criteria: January 14, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Disease Attributes; Trauma, Nervous System; Wounds, Nonpenetrating; Wounds, Penetrating; Emergencies; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic; Craniocerebral Trauma; Head Injuries, Closed; Head Injuries, Penetrating
• Other Study ID Numbers: NIMAO/2020-1/NM-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No