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

Closed Head Injury Clinical Trial

— 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05210855
• Other study ID #: NIMAO/2020-1/NM-02
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2022
• Est. completion date: September 2022

Study information

• Verified date: January 2022
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: Djamel Dabli
• Phone: 04.66.68.33.10
• Email: djamel.dabli[@]chu-nimes.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 77
• Est. completion date: September 2022
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Closed Head Injury
• Craniocerebral Trauma
• Emergencies
• Head Injuries, Closed
• Head Injuries, Penetrating
• Penetrating Head Injury
• Wounds and Injuries

Intervention

Diagnostic Test:
• CT scan
Scan with classic dose followed by ultra-low dose

Locations

Country	Name	City	State
France	CHU de Nimes	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

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