NCT05210855

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 14, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 27, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

May 12, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 19, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 19, 2023

Completed
Last Updated

March 10, 2025

Status Verified

March 1, 2025

Enrollment Period

1.4 years

First QC Date

January 14, 2022

Last Update Submit

March 7, 2025

Conditions

Closed Head InjuryPenetrating Head Injury

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (12)

  • 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)

    Day 0

  • Presence of at least one extradural hematoma by ultra-low dose versus classical scanner

    Day 0

  • Presence of at least one subarachnoid hemorrhage by ultra-low dose versus classical scanner

    Day 0

  • Presence of at least one subdural hematoma by ultra-low dose versus classical scanner

    Day 0

  • Presence of at least one intraparenchymal hemorrhage by ultra-low dose versus classical scanner

    Day 0

  • +7 more secondary outcomes

Study Arms (1)

Patients with head trauma

EXPERIMENTAL
Diagnostic Test: CT scan

Interventions

CT scanDIAGNOSTIC_TEST

Scan with classic dose followed by ultra-low dose

Patients with head trauma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patient is pregnant, parturient or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nimes

Nîmes, France

Location

MeSH Terms

Conditions

Head Injuries, ClosedHead Injuries, Penetrating

Interventions

Tomography, X-Ray Computed

Condition Hierarchy (Ancestors)

Craniocerebral TraumaTrauma, Nervous SystemNervous System DiseasesWounds and InjuriesWounds, NonpenetratingWounds, Penetrating

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-AssistedDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisRadiographic Image EnhancementImage EnhancementPhotographyRadiographyTomography, X-RayTomography

Study Officials

  • Nicolas Menjot de Champfleur

    CHU Nimes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2022

First Posted

January 27, 2022

Study Start

May 12, 2022

Primary Completion

October 19, 2023

Study Completion

October 19, 2023

Last Updated

March 10, 2025

Record last verified: 2025-03

Locations

FR(1)