Concordance Between Ultra-low Dose (ULD) and Standard Dose CT Scans in the Search for Traumatic Brain Injury

Head Injuries, Closed Clinical Trial

— ULD-CRANE  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04939688
• Other study ID #: NIMAO/2020-1/NM-01
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: March 1, 2023

Study information

• Verified date: June 2021
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: Nicolas MENJEOT DE CHAMPFLEUR, Dr.
• Phone: +334.66.68.33.10
• Email: nicolasdechampfleur[@]icloud.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 446
• Est. completion date: March 1, 2023
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
France	Nîmes University Hospital	Nîmes	Gard

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

References & Publications (7)

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. — View Citation

Greffier 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. — View Citation

Larbi 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. — View Citation

Maas 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. — View Citation

Macri 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. — View Citation

Macri 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. — View Citation

Widmann 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient's age	In years	Day 0
Other	Patient's weight	In kilos	Day 0
Other	Patient's height	In cm	Day 0
Other	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)	Day 0
Other	Type of trauma	The type of trauma will be recorded	Day 0
Other	Circumstances of trauma	The circumstances of the trauma will be recorded	Day 0
Primary	Presence of at least one extradural hematoma found on the standard dose CT-scan	YES/NO	Day 0
Primary	Presence of at least one extradural hematoma found on the ultra low-dose CT-scan	YES/NO	Day 0
Primary	Presence of at least one subarachnoid hemorrhage found on the standard dose CT-scan	YES/NO	Day 0
Primary	Presence of at least one subarachnoid hemorrhage found on the ultra low-dose CT-scan	YES/NO	Day 0
Primary	Presence of at least one subdural hematoma found on the standard dose CT-scan	YES/NO	Day 0
Primary	Presence of at least one subdural hematoma found on the ultra low-dose CT-scan	YES/NO	Day 0
Primary	Presence of at least one intraparenchymal hemorrhage found on the standard dose CT-scan	YES/NO	Day 0
Primary	Presence of at least one intraparenchymal hemorrhage found on the ultra low-dose CT-scan	YES/NO	Day 0
Secondary	A. Presence of at least one bone lesion in the skull, arch or face found on the standard dose CT-scan	YES/NO	Day 0
Secondary	A. Presence of at least one bone lesion in the skull, arch or face found on the ultra low-dose CT-scan	YES/NO	Day 0
Secondary	B. Presence of at least one intracranial hemorrhagic lesion found on the standard dose CT-scan	YES/NO	Day 0
Secondary	B. Presence of at least one intracranial hemorrhagic lesion found on the ultra low-dose CT-scan	YES/NO	Day 0
Secondary	C. Presence of at least one cranial bone lesion found on the standard dose CT-scan	YES/NO	Day 0
Secondary	C. Presence of at least one cranial bone lesion found on the ultra low-dose CT-scan	YES/NO	Day 0
Secondary	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	Day 0
Secondary	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	Day 0
Secondary	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	Day 0
Secondary	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	Day 0
Secondary	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)	Day 0
Secondary	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)	Day 0
Secondary	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)	Day 0
Secondary	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)	Day 0
Secondary	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)	Day 0
Secondary	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)	Day 0
Secondary	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	Day 0
Secondary	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	Day 0
Secondary	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	Day 0
Secondary	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	Day 0
Secondary	H. Interpretation time with the standard dose CT-scan	The time taken to interpret the images will be measured in minutes	Day 0
Secondary	H. Interpretation time with the ultra low-dose CT-scan	The time taken to interpret the images will be measured in minutes	Day 0
Secondary	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	Day 0
Secondary	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	Day 0
Secondary	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	Day 0
Secondary	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	Day 0