Closed Head InjuryULD-CRANE 2NCT05210855
Comparison of Image Quality Between Ultra-low Dose (ULD) and Standard Dose CT Scans in Detecting Traumatic Brain Injury in the Emergency Room
A study testing CT scan in people with Closed Head Injury and Penetrating Head Injury, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Closed Head Injury, Penetrating Head Injury
- What is being tested?
- CT scan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteFrance
- Study dates
- 12 May 2022to 19 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Closed Head Injury, Penetrating Head Injury
- Being tested
- CT scan
- Medical subject headings
- Head Injuries, Closed, Head Injuries, Penetrating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT scanDiagnostic test
Scan with classic dose followed by ultra-low dose
| Study group | Role | What they receive |
|---|---|---|
| Patients with head trauma | Experimental | Not described Receives: Diagnostic Test: CT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Total score of the 5 Likert scores
Measured: Day 0
Presence of at least one extradural hematoma by ultra-low dose versus classical scanner
Yes/no
Measured: Day 0
Presence of at least one subarachnoid hemorrhage by ultra-low dose versus classical scanner
Yes/no
Measured: Day 0
Presence of at least one subdural hematoma by ultra-low dose versus classical scanner
Yes/no
Measured: Day 0
Presence of at least one intraparenchymal hemorrhage by ultra-low dose versus classical scanner
Yes/no
Measured: Day 0
Presence of at least one intracranial hemorrhage by ultra-low dose versus classical scanner
Yes/no
Measured: Day 0
Presence of at least one cranial bone lesion by ultra-low dose versus classical scanner
Yes/no
Measured: Day 0
Presence of at least one bone lesion by ultra-low dose versus classical scanner
Yes/no
Measured: 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
Measured: Day 0
Radiologist-reported diagnostic quality of ultra-low dose versus classical scanner
4-point Likert scale: unacceptable, sub-optimal, acceptable, better than average
Measured: Day 0
Radiologist-reported confidence level of ultra-low dose versus classical scanner
4-point Likert scale: unacceptable, sub-optimal, acceptable, better than average
Measured: Day 0
Interpretation time of ultra-low dose versus classical scanner for a senior and junior evaluator
Minutes
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start12 May 2022
- Primary completion19 Oct 2023
- Study completion19 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Closed Head InjuryStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas Menjot de Champfleur, Principal investigator, CHU Nimes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05210855
- Sponsor's protocol ID
- NIMAO/2020-1/NM-02
- Acronym
- ULD-CRANE 2
- Status last verified
- Mar 2025
- First submitted
- 14 Jan 2022
- Last updated
- 10 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05210855
- Acronym / sponsor ID
- ULD-CRANE 2 / NIMAO/2020-1/NM-02
- Conditions
- Closed Head Injury, Penetrating Head Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 12 May 2022 (actual)
- Primary completion
- 19 Oct 2023 (actual)
- Study completion
- 19 Oct 2023 (actual)
- First posted
- 27 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with head trauma | Experimental | Diagnostic Test: CT scan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT scanScan with classic dose followed by ultra-low dose | Diagnostic test | Patients with head trauma |
Primary outcome
Image quality of ultra-low dose scan compared to classic dose for visualising the differentiation of grey/white matter
Time frame: Day 0
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
Time frame: Day 0
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
Time frame: Day 0
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
Time frame: Day 0
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
Time frame: Day 0
5-point scale: unacceptable, sub-optimal, acceptable, better than average
12 secondary outcomes
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)
Time frame: Day 0
Presence of at least one extradural hematoma by ultra-low dose versus classical scanner
Time frame: Day 0
Presence of at least one subarachnoid hemorrhage by ultra-low dose versus classical scanner
Time frame: Day 0
Presence of at least one subdural hematoma by ultra-low dose versus classical scanner
Time frame: Day 0
Presence of at least one intraparenchymal hemorrhage by ultra-low dose versus classical scanner
Time frame: Day 0
Presence of at least one intracranial hemorrhage by ultra-low dose versus classical scanner
Time frame: Day 0
Presence of at least one cranial bone lesion by ultra-low dose versus classical scanner
Time frame: Day 0
Presence of at least one bone lesion by ultra-low dose versus classical scanner
Time frame: Day 0
Radiologist-reported image quality of ultra-low dose versus classical scanner
Time frame: Day 0
Radiologist-reported diagnostic quality of ultra-low dose versus classical scanner
Time frame: Day 0
Radiologist-reported confidence level of ultra-low dose versus classical scanner
Time frame: Day 0
Interpretation time of ultra-low dose versus classical scanner for a senior and junior evaluator
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
Related trials for Closed Head Injury
Enrolling by invitationPhase 1
Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
Mild Traumatic Brain Injury
Recruiting
Evaluation of Cognitive Behavioral Therapy for Insomnia (CBT-I) in Individuals With Mild Traumatic Brain Injury (mTBI)
Sleep Architecture, Mild Traumatic Brain Injury
Active, not recruiting
Pilot TMS in Mild TBI
Persistent Post Concussive Headache, Mild Traumatic Brain Injury
Recruiting
Non-invasive Stimulation of the Glymphatic System for Slowing Cognitive Decline
Mild Traumatic Brain Injury, Post Concussion Syndrome
Enrolling by invitation
Improving In-hospital and Post-discharge Patient Education for Mild Traumatic Brain Injury
Concussion, Mild, Traumatic Brain Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas Menjot de Champfleur principal investigator
CHU Nimes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT scan in people with Closed Head Injury and Penetrating Head Injury, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Image quality of ultra-low dose scan compared to classic dose for visualising the differentiation of grey/white matter (time frame: Day 0). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2025.