An interventional study of Conventional dose AND ultra low-dose CT scanning in the search for cranial lesions in Head Injuries, Penetrating and Head Injuries, Closed, sponsored by Centre Hospitalier Universitaire de Nīmes. Terminated at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-10.
Sponsored by Centre Hospitalier Universitaire de Nīmes · Not applicable, Interventional, and Diagnostic
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.
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.
2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.
This study's enrollment of 2 is below the median of 48 across 1,331 interventional studies indexed under Brain Injuries.
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Exclusion Criteria:
All patients will undergo both conventional dose AND ultra low-dose CT scans in the search for cranial lesions following head trauma.
Radiation: Conventional dose AND ultra low-dose CT scanning in the search for cranial lesions
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.
Presence of at least one extradural hematoma found on the standard dose CT-scan
YES/NO
Time frame: Day 0
Presence of at least one extradural hematoma found on the ultra low-dose CT-scan
YES/NO
Time frame: Day 0
Presence of at least one subarachnoid hemorrhage found on the standard dose CT-scan
YES/NO
Time frame: Day 0
Presence of at least one subarachnoid hemorrhage found on the ultra low-dose CT-scan
YES/NO
Time frame: Day 0
Presence of at least one subdural hematoma found on the standard dose CT-scan
YES/NO
Time frame: Day 0
Presence of at least one subdural hematoma found on the ultra low-dose CT-scan
YES/NO
Time frame: Day 0
Presence of at least one intraparenchymal hemorrhage found on the standard dose CT-scan
YES/NO
Time frame: Day 0
Presence of at least one intraparenchymal hemorrhage found on the ultra low-dose CT-scan
YES/NO
Time frame: Day 0
A. Presence of at least one bone lesion in the skull, arch or face found on the standard dose CT-scan
YES/NO
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
YES/NO
Time frame: Day 0
B. Presence of at least one intracranial hemorrhagic lesion found on the standard dose CT-scan
YES/NO
Time frame: Day 0
B. Presence of at least one intracranial hemorrhagic lesion found on the ultra low-dose CT-scan
YES/NO
Time frame: Day 0
C. Presence of at least one cranial bone lesion found on the standard dose CT-scan
YES/NO
Time frame: Day 0
C. Presence of at least one cranial bone lesion found on the ultra low-dose CT-scan
YES/NO
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.
YES/NO
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.
YES/NO
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
YES/NO
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
YES/NO
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Day 0
H. Interpretation time with the standard dose CT-scan
The time taken to interpret the images will be measured in minutes
Time frame: Day 0
H. Interpretation time with the ultra low-dose CT-scan
The time taken to interpret the images will be measured in minutes
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.
YES/NO
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
YES/NO
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
YES/NO
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
YES/NO
Time frame: Day 0
Patient's age
In years
Time frame: Day 0
Patient's weight
In kilos
Time frame: Day 0
Patient's height
In cm
Time frame: Day 0
Patient's Body Mass Index
The patient's Body Mass Index will be calculated by computer according to the patient's weight and height (in Kg/m²)
Time frame: Day 0
Type of trauma
The type of trauma will be recorded
Time frame: Day 0
Circumstances of trauma
The circumstances of the trauma will be recorded
Time frame: Day 0
This study is terminated, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Universitaire de Nīmes