Head Injuries, PenetratingULD-CRANENCT04939688
Concordance Between Ultra-low Dose (ULD) and Standard Dose CT Scans in the Search for Traumatic Brain Injury
A study testing Conventional dose AND ultra low-dose CT scanning in the search for cranial lesions in people with Head Injuries, Penetrating and Head Injuries, Closed, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
The aim of this research is to evaluate the diagnostic concordance of ultra low-dose and standard dose reconstructed computed tomography acquisitions using the ADMIRE algorithm to search for intracranial lesions - both hemorrhagic and bone lesions - in trauma patients at the emergency department. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head Injuries, Penetrating, Head Injuries, Closed
- What is being tested?
- Conventional dose AND ultra low-dose CT scanning in the search for cranial lesions
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteFrance
- Study dates
- 26 Jun 2021to 19 Jul 2021
- 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
- All patients in an emergency situation with a head trauma requiring a scan, i.e. moderate or severe skull trauma, Group 1 or 2 according to the Brain Trauma Task Force classification (Guidelines for management of severe head injury. J Neurotrauma 2000 ; 17 : 507-11) as described by P. Schoettker et al. 2001).
- Patient with an isolated skull trauma or polytraumatized patient including skull trauma.
- Patient capable of giving informed consent or for whom a person of confidence or legal representative / family member has given informed consent and signed the consent form on the patient's behalf if the patient has been included in an emergency.
- Patients affiliated to or beneficiary of a health insurance scheme.
- All adult patients aged 18 or over.
Who cannot join
- Patients already taking part in another study for which it is not allowed to participate in other clinical studies.
- Patients in an exclusion period determined by another study.
- Patients who are pregnant, breastfeeding or about to give birth.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Concordance Between Ultra-low Dose (ULD) and Conventional Standard Dose CT Scans in the Search for Traumatic Brain Injury at the Emergency Department
The aim of this research is to evaluate the diagnostic concordance of ultra low-dose and standard dose reconstructed computed tomography acquisitions using the ADMIRE algorithm to search for intracranial lesions - both hemorrhagic and bone lesions - in trauma patients at the emergency department. The study will also evaluate the diagnostic performance of the two protocols, as well as the speed of image reading. For the first time, acquisitions ≤ 10 mGy (lower value than reported in the literature) will be performed with top-of-the-range scanners available in the emergency room to search for intracranial lesions. These scanners are equipped with the latest generation of ADMIRE iterative algorithms.
Read the detailed description
Head trauma is a common reason for consultation at the casualty department. The CT computed tomography scan is the standard examination leading to rapid patient management (admission to intensive care or neurosurgical management). The prevalence of traumatic lesions, intracranial bleeding or fractures, is estimated at 90% in moderate or severe head trauma patients, justifying the systematic use of a CT scan.
X-ray exposure from CT scanners is among the highest (order of May 23, 2019 for the Diagnostic Reference Levels, DRL). Radiation protection principles therefore require continuous optimization of acquisition procedures to ensure the lowest possible dose to the patient whilst maintaining satisfactory image quality for diagnosis. In recent years, technological innovations have been developed to optimize the dose delivered to the scanner, such as iterative reconstructions. Numerous studies on image quality and anthropomorphic phantoms and on cadavers have been performed at the imaging department of Nîmes University Hospital. Subsequently, feasibility studies have been conducted on patients, highlighting the use of the ultra low-dose scanner to detect common pathologies. These studies have made it possible to set up "ultra-low dose" acquisitions for several pathologies with an effective dose level close to a standard radiographic examination. These ultra low-dose acquisitions are now routinely used in our clinical practice for thoracic, spine, pelvis and proximal femurs, extremities and abdomino-pelvic explorations.
In the literature, some studies have explored the feasibility of ultra low-dose acquisitions for ear, nose and throat or skull explorations. Our study is in the context of evaluating ULD acquisitions for skull CT for traumatic intracranial lesions. The study by Corcuera-Solano et al. (2014) showed the feasibility of ULD acquisitions (Scanographic Dose Index in Volume, mean SDVI = 15.5 mGy) compared to standard acquisition (mean SDVI = 48.38 mGy) in the follow-up of a heterogeneous group of patients admitted to the neurosurgical intensive care unit, without evaluating the diagnostic performance of the two acquisitions. In this study, the Siemens scanner used was equipped with a 2nd generation iterative reconstruction algorithm (SAFIRE).
A 3rd generation algorithm has since been developed (ADMIRE) allowing an improvement in image texture, thus favoring the use of ultra low-dose acquisition for structures with lower spontaneous contrast such as the encephalon. We believe it would therefore be possible to search for intracranial lesions in trauma patients using ultra low-dose protocols, which should make it possible to reduce the doses delivered to the patient whilst maintaining sufficient image quality for diagnosis.
- Conditions
- Head Injuries, Penetrating, Head Injuries, Closed
- Being tested
- Conventional dose AND ultra low-dose CT scanning in the search for cranial lesions
- Medical subject headings
- Head Injuries, Penetrating, Head Injuries, Closed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional dose AND ultra low-dose CT scanning in the search for cranial lesionsRadiation
As well as undergoing the usual, conventional radiation dose CT scan, these patients will also undergo ultra low-dose CT scanning in the search for cranial lesions.
| Study group | Role | What they receive |
|---|---|---|
| Patients requiring a CT scan in the search for cranial lesions following head trauma | Experimental | All patients will undergo both conventional dose AND ultra low-dose CT scans in the search for cranial lesions following head trauma. Receives: Radiation: Conventional dose AND ultra low-dose CT scanning in the search for cranial lesions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of at least one extradural hematoma found on the standard dose CT-scan
YES/NO
Measured: Day 0
Presence of at least one extradural hematoma found on the ultra low-dose CT-scan
YES/NO
Measured: Day 0
Presence of at least one subarachnoid hemorrhage found on the standard dose CT-scan
YES/NO
Measured: Day 0
Presence of at least one subarachnoid hemorrhage found on the ultra low-dose CT-scan
YES/NO
Measured: Day 0
Presence of at least one subdural hematoma found on the standard dose CT-scan
YES/NO
Measured: Day 0
Presence of at least one subdural hematoma found on the ultra low-dose CT-scan
YES/NO
Measured: Day 0
Presence of at least one intraparenchymal hemorrhage found on the standard dose CT-scan
YES/NO
Measured: Day 0
Presence of at least one intraparenchymal hemorrhage found on the ultra low-dose CT-scan
YES/NO
Measured: Day 0
Secondary outcomes (26)
A. Presence of at least one bone lesion in the skull, arch or face found on the standard dose CT-scan
YES/NO
Measured: Day 0
A. Presence of at least one bone lesion in the skull, arch or face found on the ultra low-dose CT-scan
YES/NO
Measured: Day 0
B. Presence of at least one intracranial hemorrhagic lesion found on the standard dose CT-scan
YES/NO
Measured: Day 0
B. Presence of at least one intracranial hemorrhagic lesion found on the ultra low-dose CT-scan
YES/NO
Measured: Day 0
C. Presence of at least one cranial bone lesion found on the standard dose CT-scan
YES/NO
Measured: Day 0
C. Presence of at least one cranial bone lesion found on the ultra low-dose CT-scan
YES/NO
Measured: Day 0
D. Presence of at least one intracranial hemorrhagic lesion and presence of at least one bone lesion found on the standard dose CT-scan according to the radiologist.
YES/NO
Measured: Day 0
D. Presence of at least one intracranial hemorrhagic lesion and presence of at least one bone lesion found on the ultra low-dose CT-scan according to the radiologist.
YES/NO
Measured: Day 0
E. Presence of at least one intracranial hemorrhagic lesion and presence of at least one bone lesion found on the standard dose CT-scan
YES/NO
Measured: Day 0
E. Presence of at least one intracranial hemorrhagic lesion and presence of at least one bone lesion found on the ultra low-dose CT-scan
YES/NO
Measured: Day 0
Fi.Radiologist's appreciation of the standard dose CT-scan: image quality
A scale of 1 - 4 will be used (1 = interpretable, 2 = interpretable despite a slight technical problem (centering, movement, constants) 3 = completely interpretable despite a slight technical problem, 4 = no technical problems)
Measured: Day 0
Fi.Radiologist's appreciation of the ultra low-dose CT-scan: image quality
A scale of 1 - 4 will be used (1 = interpretable, 2 = interpretable despite a slight technical problem (centering, movement, constants) 3 = completely interpretable despite a slight technical problem, 4 = no technical problems)
Measured: Day 0
Fii.Radiologist's appreciation of the standard dose CT-scan: diagnostic quality
A scale of 1 - 5 will be used (1 = unacceptable, 2 = sub-optimal, 3 = acceptable, 4 = above average, 5 = excellent)
Measured: Day 0
Fii.Radiologist's appreciation of the ultra low-dose CT-scan: diagnostic quality
A scale of 1 - 5 will be used A scale of 1 - 5 will be used (1 = unacceptable, 2 = sub-optimal, 3 = acceptable, 4 = above average, 5 = excellent)
Measured: Day 0
Fiii.Radiologist's appreciation of the standard dose CT-scan: level of confidence
A scale of 1 - 5 will be used (1 = very poor, 2 = poor, 3 = moderate, 4 = high, 5 = excellent)
Measured: Day 0
Fiii.Radiologist's appreciation of the ultra low-dose CT-scan: level of confidence
A scale of 1 - 5 will be used (1 = very poor, 2 = poor, 3 = moderate, 4 = high, 5 = excellent)
Measured: Day 0
G. Total dose of X-rays delivered with the standard dose CT-scan : DLP
DACS (Dose Archiving and Communication System) will be used to measure Dose Length Product (DLP) measured in mGy*cm
Measured: Day 0
G. Total dose of X-rays delivered with the ultra low-dose CT-scan : DLP
DACS (Dose Archiving and Communication System) will be used to measure Dose Length Product (DLP) measured in mGy*cm
Measured: Day 0
G. Total dose of X-rays delivered with the standard dose CT-scan : CTDI
DACS (Dose Archiving and Communication System) will be used to measure Computed Tomography Dose Index in mGy
Measured: Day 0
G. Total dose of X-rays delivered with the ultra low-dose CT-scan : CTDI
DACS (Dose Archiving and Communication System) will be used to measure Computed Tomography Dose Index in mGy
Measured: Day 0
H. Interpretation time with the standard dose CT-scan
The time taken to interpret the images will be measured in minutes
Measured: Day 0
H. Interpretation time with the ultra low-dose CT-scan
The time taken to interpret the images will be measured in minutes
Measured: Day 0
I. Performance of standard dose CT-scan for polytrauma patients. Presence of at least one intracranial hemorrhagic lesion and presence of at least one bone lesion.
YES/NO
Measured: Day 0
I. Performance of the ultra low-dose CT-scan for patients with skull trauma alone. Presence of at least one intracranial hemorrhagic lesion and presence of at least one bone lesion
YES/NO
Measured: Day 0
I. General performance of the ultra low-dose CT-scan for polytrauma patients: Presence of at least one intracranial hemorrhagic lesion and presence of at least one bone lesion
YES/NO
Measured: Day 0
I. General performance of the standard dose CT-scan for patients with skull trauma alone. Presence of at least one intracranial hemorrhagic lesion and presence of at least one bone lesion
YES/NO
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 posted25 Jun 2021
- Study start26 Jun 2021
- Primary completion19 Jul 2021
- Study completion19 Jul 2021
Why it stopped: Recruitment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Head Injuries, PenetratingStudies 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
- Model description
- All patients requiring investigation of traumatic injuries after moderate or severe head trauma as identified at the emergency department. All patients will receive a standard dose CT scan of the skull according to the usual management, as well as a ULD scan of the same area, performed specifically for the needs of the study, following a pre-established standardized protocol. The center's radiologist will interpret the conventional CT scan in real time for patient diagnosis and management, but this interpretation will not be used in the study. The patient will then be redirected to the emergency department for his or her usual management.
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas MENJEOT DE CHAMPFLEUR, Principal investigator, Nîmes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04939688
- Sponsor's protocol ID
- NIMAO/2020-1/NM-01
- Acronym
- ULD-CRANE
- Status last verified
- Mar 2025
- First submitted
- 17 Jun 2021
- Last updated
- 10 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Greffier J, Fernandez A, Macri F, Freitag C, Metge L, Beregi JP. Which dose for what image? Iterative reconstruction for CT scan. Diagn Interv Imaging. 2013 Nov;94(11):1117-21. doi: 10.1016/j.diii.2013.03.008. Epub 2013 Jun 22.
PubMed 23796396Greffier J, Macri F, Larbi A, Fernandez A, Khasanova E, Pereira F, Mekkaoui C, Beregi JP. Dose reduction with iterative reconstruction: Optimization of CT protocols in clinical practice. Diagn Interv Imaging. 2015 May;96(5):477-86. doi: 10.1016/j.diii.2015.02.007. Epub 2015 Mar 19.
PubMed 25797211Larbi A, Orliac C, Frandon J, Pereira F, Ruyer A, Goupil J, Macri F, Beregi JP, Greffier J. Detection and characterization of focal liver lesions with ultra-low dose computed tomography in neoplastic patients. Diagn Interv Imaging. 2018 May;99(5):311-320. doi: 10.1016/j.diii.2017.11.003. Epub 2018 Feb 1.
PubMed 29396085Maas AI, Hukkelhoven CW, Marshall LF, Steyerberg EW. Prediction of outcome in traumatic brain injury with computed tomographic characteristics: a comparison between the computed tomographic classification and combinations of computed tomographic predictors. Neurosurgery. 2005 Dec;57(6):1173-82; discussion 1173-82. doi: 10.1227/01.neu.0000186013.63046.6b.
PubMed 16331165Macri F, Greffier J, Pereira F, Rosa AC, Khasanova E, Claret PG, Larbi A, Gualdi G, Beregi JP. Value of ultra-low-dose chest CT with iterative reconstruction for selected emergency room patients with acute dyspnea. Eur J Radiol. 2016 Sep;85(9):1637-44. doi: 10.1016/j.ejrad.2016.06.024. Epub 2016 Jul 1.
PubMed 27501900Macri F, Greffier J, Pereira FR, Mandoul C, Khasanova E, Gualdi G, Beregi JP. Ultra-low-dose chest CT with iterative reconstruction does not alter anatomical image quality. Diagn Interv Imaging. 2016 Nov;97(11):1131-1140. doi: 10.1016/j.diii.2016.06.009. Epub 2016 Jul 20.
PubMed 27451261Widmann G, Juranek D, Waldenberger F, Schullian P, Dennhardt A, Hoermann R, Steurer M, Gassner EM, Puelacher W. Influence of Ultra-Low-Dose and Iterative Reconstructions on the Visualization of Orbital Soft Tissues on Maxillofacial CT. AJNR Am J Neuroradiol. 2017 Aug;38(8):1630-1635. doi: 10.3174/ajnr.A5239. Epub 2017 Jun 8.
PubMed 28596194
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
- Concordance Between Ultra-low Dose (ULD) and Conventional Standard Dose CT Scans in the Search for Traumatic Brain Injury at the Emergency Department
- ClinicalTrials.gov ID
- NCT04939688
- Acronym / sponsor ID
- ULD-CRANE / NIMAO/2020-1/NM-01
- Conditions
- Head Injuries, Penetrating, Head Injuries, Closed
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment difficulties
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 26 Jun 2021 (actual)
- Primary completion
- 19 Jul 2021 (actual)
- Study completion
- 19 Jul 2021 (actual)
- First posted
- 25 Jun 2021 (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.
The aim of this research is to evaluate the diagnostic concordance of ultra low-dose and standard dose reconstructed computed tomography acquisitions using the ADMIRE algorithm to search for intracranial lesions - both hemorrhagic and bone lesions - in trauma patients at the emergency department. The study will also evaluate the diagnostic performance of the two protocols, as well as the speed of image reading. For the first time, acquisitions ≤ 10 mGy (lower value than reported in the literature) will be performed with top-of-the-range scanners available in the emergency room to search for intracranial lesions. These scanners are equipped with the latest generation of ADMIRE iterative algorithms.
Detailed description
Head trauma is a common reason for consultation at the casualty department. The CT computed tomography scan is the standard examination leading to rapid patient management (admission to intensive care or neurosurgical management). The prevalence of traumatic lesions, intracranial bleeding or fractures, is estimated at 90% in moderate or severe head trauma patients, justifying the systematic use of a CT scan.
X-ray exposure from CT scanners is among the highest (order of May 23, 2019 for the Diagnostic Reference Levels, DRL). Radiation protection principles therefore require continuous optimization of acquisition procedures to ensure the lowest possible dose to the patient whilst maintaining satisfactory image quality for diagnosis. In recent years, technological innovations have been developed to optimize the dose delivered to the scanner, such as iterative reconstructions. Numerous studies on image quality and anthropomorphic phantoms and on cadavers have been performed at the imaging department of Nîmes University Hospital. Subsequently, feasibility studies have been conducted on patients, highlighting the use of the ultra low-dose scanner to detect common pathologies. These studies have made it possible to set up "ultra-low dose" acquisitions for several pathologies with an effective dose level close to a standard radiographic examination. These ultra low-dose acquisitions are now routinely used in our clinical practice for thoracic, spine, pelvis and proximal femurs, extremities and abdomino-pelvic explorations.
In the literature, some studies have explored the feasibility of ultra low-dose acquisitions for ear, nose and throat or skull explorations. Our study is in the context of evaluating ULD acquisitions for skull CT for traumatic intracranial lesions. The study by Corcuera-Solano et al. (2014) showed the feasibility of ULD acquisitions (Scanographic Dose Index in Volume, mean SDVI = 15.5 mGy) compared to standard acquisition (mean SDVI = 48.38 mGy) in the follow-up of a heterogeneous group of patients admitted to the neurosurgical intensive care unit, without evaluating the diagnostic performance of the two acquisitions. In this study, the Siemens scanner used was equipped with a 2nd generation iterative reconstruction algorithm (SAFIRE).
A 3rd generation algorithm has since been developed (ADMIRE) allowing an improvement in image texture, thus favoring the use of ultra low-dose acquisition for structures with lower spontaneous contrast such as the encephalon. We believe it would therefore be possible to search for intracranial lesions in trauma patients using ultra low-dose protocols, which should make it possible to reduce the doses delivered to the patient whilst maintaining sufficient image quality for diagnosis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All patients requiring investigation of traumatic injuries after moderate or severe head trauma as identified at the emergency department. All patients will receive a standard dose CT scan of the skull according to the usual management, as well as a ULD scan of the same area, performed specifically for the needs of the study, following a pre-established standardized protocol. The center's radiologist will interpret the conventional CT scan in real time for patient diagnosis and management, but this interpretation will not be used in the study. The patient will then be redirected to the emergency department for his or her usual management.
| Arm | Type | Receives |
|---|---|---|
| Patients requiring a CT scan in the search for cranial lesions following head trauma | Experimental | Radiation: Conventional dose AND ultra low-dose CT scanning in the search for cranial lesionsAll patients will undergo both conventional dose AND ultra low-dose CT scans in the search for cranial lesions following head trauma. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- All patients in an emergency situation with a head trauma requiring a scan, i.e. moderate or severe skull trauma, Group 1 or 2 according to the Brain Trauma Task Force classification (Guidelines for management of severe head injury. J Neurotrauma 2000 ; 17 : 507-11) as described by P. Schoettker et al. 2001).
- Patient with an isolated skull trauma or polytraumatized patient including skull trauma.
- Patient capable of giving informed consent or for whom a person of confidence or legal representative / family member has given informed consent and signed the consent form on the patient's behalf if the patient has been included in an emergency.
- Patients affiliated to or beneficiary of a health insurance scheme.
- All adult patients aged 18 or over.
Key exclusion criteria (3 listed)
- Patients already taking part in another study for which it is not allowed to participate in other clinical studies.
- Patients in an exclusion period determined by another study.
- Patients who are pregnant, breastfeeding or about to give birth.
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 |
|---|---|---|
| Conventional dose AND ultra low-dose CT scanning in the search for cranial lesionsAs well as undergoing the usual, conventional radiation dose CT scan, these patients will also undergo ultra low-dose CT scanning in the search for cranial lesions. | Radiation | Patients requiring a CT scan in the search for cranial lesions following head trauma |
Primary outcome
Presence of at least one extradural hematoma found on the standard dose CT-scan
Time frame: Day 0
YES/NO
Presence of at least one extradural hematoma found on the ultra low-dose CT-scan
Time frame: Day 0
YES/NO
Presence of at least one subarachnoid hemorrhage found on the standard dose CT-scan
Time frame: Day 0
YES/NO
Presence of at least one subarachnoid hemorrhage found on the ultra low-dose CT-scan
Time frame: Day 0
YES/NO
Presence of at least one subdural hematoma found on the standard dose CT-scan
Time frame: Day 0
YES/NO
Presence of at least one subdural hematoma found on the ultra low-dose CT-scan
Time frame: Day 0
YES/NO
Presence of at least one intraparenchymal hemorrhage found on the standard dose CT-scan
Time frame: Day 0
YES/NO
Presence of at least one intraparenchymal hemorrhage found on the ultra low-dose CT-scan
Time frame: Day 0
YES/NO
26 secondary outcomes
A. Presence of at least one bone lesion in the skull, arch or face found on the standard dose CT-scan
Time frame: Day 0
A. Presence of at least one bone lesion in the skull, arch or face found on the ultra low-dose CT-scan
Time frame: Day 0
B. Presence of at least one intracranial hemorrhagic lesion found on the standard dose CT-scan
Time frame: Day 0
B. Presence of at least one intracranial hemorrhagic lesion found on the ultra low-dose CT-scan
Time frame: Day 0
C. Presence of at least one cranial bone lesion found on the standard dose CT-scan
Time frame: Day 0
C. Presence of at least one cranial bone lesion found on the ultra low-dose CT-scan
Time frame: Day 0
D. Presence of at least one intracranial hemorrhagic lesion and presence of at least one bone lesion found on the standard dose CT-scan according to the radiologist.
Time frame: Day 0
D. Presence of at least one intracranial hemorrhagic lesion and presence of at least one bone lesion found on the ultra low-dose CT-scan according to the radiologist.
Time frame: Day 0
E. Presence of at least one intracranial hemorrhagic lesion and presence of at least one bone lesion found on the standard dose CT-scan
Time frame: Day 0
E. Presence of at least one intracranial hemorrhagic lesion and presence of at least one bone lesion found on the ultra low-dose CT-scan
Time frame: Day 0
Fi.Radiologist's appreciation of the standard dose CT-scan: image quality
Time frame: Day 0
Fi.Radiologist's appreciation of the ultra low-dose CT-scan: image quality
Time frame: Day 0
Fii.Radiologist's appreciation of the standard dose CT-scan: diagnostic quality
Time frame: Day 0
Fii.Radiologist's appreciation of the ultra low-dose CT-scan: diagnostic quality
Time frame: Day 0
Fiii.Radiologist's appreciation of the standard dose CT-scan: level of confidence
Time frame: Day 0
Fiii.Radiologist's appreciation of the ultra low-dose CT-scan: level of confidence
Time frame: Day 0
G. Total dose of X-rays delivered with the standard dose CT-scan : DLP
Time frame: Day 0
G. Total dose of X-rays delivered with the ultra low-dose CT-scan : DLP
Time frame: Day 0
G. Total dose of X-rays delivered with the standard dose CT-scan : CTDI
Time frame: Day 0
G. Total dose of X-rays delivered with the ultra low-dose CT-scan : CTDI
Time frame: Day 0
H. Interpretation time with the standard dose CT-scan
Time frame: Day 0
H. Interpretation time with the ultra low-dose CT-scan
Time frame: Day 0
I. Performance of standard dose CT-scan for polytrauma patients. Presence of at least one intracranial hemorrhagic lesion and presence of at least one bone lesion.
Time frame: Day 0
I. Performance of the ultra low-dose CT-scan for patients with skull trauma alone. Presence of at least one intracranial hemorrhagic lesion and presence of at least one bone lesion
Time frame: Day 0
I. General performance of the ultra low-dose CT-scan for polytrauma patients: Presence of at least one intracranial hemorrhagic lesion and presence of at least one bone lesion
Time frame: Day 0
I. General performance of the standard dose CT-scan for patients with skull trauma alone. Presence of at least one intracranial hemorrhagic lesion and presence of at least one bone lesion
Time frame: Day 0
Results and safety
The study was stopped early (reason given: Recruitment difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- Background: PubMed 23796396Greffier J, Fernandez A, Macri F, Freitag C, Metge L, Beregi JP. Which dose for what image? Iterative reconstruction for CT scan. Diagn Interv Imaging. 2013 Nov;94(11):1117-21. doi: 10.1016/j.diii.2013.03.008. Epub 2013 Jun 22.
- Background: PubMed 25797211Greffier J, Macri F, Larbi A, Fernandez A, Khasanova E, Pereira F, Mekkaoui C, Beregi JP. Dose reduction with iterative reconstruction: Optimization of CT protocols in clinical practice. Diagn Interv Imaging. 2015 May;96(5):477-86. doi: 10.1016/j.diii.2015.02.007. Epub 2015 Mar 19.
- Background: PubMed 29396085Larbi A, Orliac C, Frandon J, Pereira F, Ruyer A, Goupil J, Macri F, Beregi JP, Greffier J. Detection and characterization of focal liver lesions with ultra-low dose computed tomography in neoplastic patients. Diagn Interv Imaging. 2018 May;99(5):311-320. doi: 10.1016/j.diii.2017.11.003. Epub 2018 Feb 1.
- Background: PubMed 16331165Maas AI, Hukkelhoven CW, Marshall LF, Steyerberg EW. Prediction of outcome in traumatic brain injury with computed tomographic characteristics: a comparison between the computed tomographic classification and combinations of computed tomographic predictors. Neurosurgery. 2005 Dec;57(6):1173-82; discussion 1173-82. doi: 10.1227/01.neu.0000186013.63046.6b.
- Background: PubMed 27501900Macri F, Greffier J, Pereira F, Rosa AC, Khasanova E, Claret PG, Larbi A, Gualdi G, Beregi JP. Value of ultra-low-dose chest CT with iterative reconstruction for selected emergency room patients with acute dyspnea. Eur J Radiol. 2016 Sep;85(9):1637-44. doi: 10.1016/j.ejrad.2016.06.024. Epub 2016 Jul 1.
- Background: PubMed 27451261Macri F, Greffier J, Pereira FR, Mandoul C, Khasanova E, Gualdi G, Beregi JP. Ultra-low-dose chest CT with iterative reconstruction does not alter anatomical image quality. Diagn Interv Imaging. 2016 Nov;97(11):1131-1140. doi: 10.1016/j.diii.2016.06.009. Epub 2016 Jul 20.
- Background: PubMed 28596194Widmann G, Juranek D, Waldenberger F, Schullian P, Dennhardt A, Hoermann R, Steurer M, Gassner EM, Puelacher W. Influence of Ultra-Low-Dose and Iterative Reconstructions on the Visualization of Orbital Soft Tissues on Maxillofacial CT. AJNR Am J Neuroradiol. 2017 Aug;38(8):1630-1635. doi: 10.3174/ajnr.A5239. Epub 2017 Jun 8.
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Not yet recruitingObservational study
BRIDGE-US: Bridging Readiness in Deployed Neurotrauma Gaps for Excellence
Brain Injuries, Acute, Brain Trauma
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 MENJEOT DE CHAMPFLEUR principal investigator
Nîmes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional dose AND ultra low-dose CT scanning in the search for cranial lesions in people with Head Injuries, Penetrating and Head Injuries, Closed, 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 5 inclusion and 3 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: stopped early, 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 was stopped early (reason given: Recruitment difficulties). Results are not available in the source record.
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?
Presence of at least one extradural hematoma found on the standard dose CT-scan (time frame: Day 0). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04939688, which also lists 7 linked publications.
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; AzTrials last refreshed its copy on 3 Nov 2026.