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

NCT04939688 | Terminated

• 1 other identifier: NIMAO/2020-1/NM-01
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Head Injuries, Penetrating; Head Injuries, Closed

Outcome Measures

Primary Outcomes (8)

• Presence of at least one extradural hematoma found on the standard dose CT-scan

  YES/NO

  Day 0

• Presence of at least one extradural hematoma found on the ultra low-dose CT-scan

  YES/NO

  Day 0

• Presence of at least one subarachnoid hemorrhage found on the standard dose CT-scan

  YES/NO

  Day 0

• Presence of at least one subarachnoid hemorrhage found on the ultra low-dose CT-scan

  YES/NO

  Day 0

• Presence of at least one subdural hematoma found on the standard dose CT-scan

  YES/NO

  Day 0

• Presence of at least one subdural hematoma found on the ultra low-dose CT-scan

  YES/NO

  Day 0

• Presence of at least one intraparenchymal hemorrhage found on the standard dose CT-scan

  YES/NO

  Day 0

• Presence of at least one intraparenchymal hemorrhage found on the ultra low-dose CT-scan

  YES/NO

  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

  Day 0

• A. Presence of at least one bone lesion in the skull, arch or face found on the ultra low-dose CT-scan

  Day 0

• B. Presence of at least one intracranial hemorrhagic lesion found on the standard dose CT-scan

  Day 0

• B. Presence of at least one intracranial hemorrhagic lesion found on the ultra low-dose CT-scan

  Day 0

• C. Presence of at least one cranial bone lesion found on the standard dose CT-scan

  Day 0

Other Outcomes (6)

• Patient's age

  Day 0

• Patient's weight

  Day 0

• Patient's height

  Day 0

Study Arms (1)

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.

Radiation: Conventional dose AND ultra low-dose CT scanning in the search for cranial lesions

Interventions

Conventional dose AND ultra low-dose CT scanning in the search for cranial lesions RADIATION

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.

Patients requiring a CT scan in the search for cranial lesions following head trauma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients already taking part in another study for which it is not allowed to participate in other clinical studies.
• Patients who are pregnant, breastfeeding or about to give birth.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

Nîmes University Hospital

Nîmes, Gard, 30029, France

Location

Related 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.

  PMID: 23796396 BACKGROUND

• 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.

  PMID: 25797211 BACKGROUND

• 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.

  PMID: 29396085 BACKGROUND

• 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. doi: 10.1227/01.neu.0000186013.63046.6b.

  PMID: 16331165 BACKGROUND

• 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.

  PMID: 27501900 BACKGROUND

• 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.

  PMID: 27451261 BACKGROUND

• 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.

  PMID: 28596194 BACKGROUND

MeSH Terms

Conditions

Head Injuries, Penetrating; Head Injuries, Closed

Condition Hierarchy (Ancestors)

Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries; Wounds, Penetrating; Wounds, Nonpenetrating

Study Officials

• Nicolas MENJEOT DE CHAMPFLEUR

  Nîmes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: All patients will have the benefit of two CT scans : one normal dose and one ultra low-dose. However, the results of scans will be interpreted by two independent radiologists (senior and junior) who do not know whether the scan has been done with the normal, classic dose or with the ultra low-dose protocol.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 17, 2021
• First Posted: June 25, 2021
• Study Start: June 26, 2021
• Primary Completion: July 19, 2021
• Study Completion: July 19, 2021
• Last Updated: March 10, 2025

Record last verified: 2025-03

Locations

FR (1)