Non contrast-enhanced short-time MRI and conventional CT: Comparison of diagnostic parameters in patients with acute neurological symptoms

• Register: German Clinical Trials Register
• Last refreshed on: 8 April 2024
• Main ID: DRKS00013356
• Date of registration: 01/12/2017
• Prospective Registration: Yes
• Primary sponsor: Klinikum der Universität München, Campus Großhadern
• Public title: Non contrast-enhanced short-time MRI and conventional CT: Comparison of diagnostic parameters in patients with acute neurological symptoms
• Scientific title: Non contrast-enhanced short-time MRI and conventional CT: Comparison of diagnostic parameters in patients with acute neurological symptoms - Ultrafast Brain MRI in Acute Neurological Emergencies: the FAMILIES trial (LMU-RAD00055)
• Date of first enrolment: 05/12/2017
• Target sample size: 150
• Recruitment status: Complete
• URL: http://drks.de/search/en/trial/DRKS00013356
• Study type: interventional
• Study design: Allocation: N/A: single arm study; Masking: Open (masking not used); Control: uncontrolled; Assignment: single; Study design purpose: diagnostic
• Phase: N/A

Countries of recruitment

Germany

Contacts

• Name: Christel Besseler
• Affiliation: Klinik und Poliklinik für Radiologie Klinikum der Universität München Campus Großhadern

• Name: Clemens Cyran
• Affiliation: Klinikum der Universität München

Key inclusion & exclusion criteria

Inclusion criteria: - patients of the emergency department of the Ludwig-Maximilians-University (LMU) Munich-Großhadern (minimum age 18 years)
- suspected intracranial pathologies (hemorrhage, ischemia, tumor, signs of inflammation, edema, increased intracranial pressure (ICP))
- insufficient explanation of symptoms after examination using the cranial computed tomography

Exclusion criteria: - patients with MRI-incompatible intracorporeal material (e.g. pacemaker, bladder pacemaker, nerve stimulators)
- lacking capability of giving consent
- minors
- claustrophobia
- unstable general condition
- pregnancy
- sufficient explanation of symptoms by the cranial computed tomography


Age minimum: 18 Years
Age maximum: None
Gender: All

Health Condition(s) or Problem(s) studied

Cerebral infarction due to thrombosis of precerebral arteries

I63.0

I67.88
I63.0
R58

Haemorrhage, not elsewhere classified

I67.88

Intervention(s)

Group 1: This study begins with the selection of suitable patients in accordance to our specified inclusion and exclusion criteria which are based upon consultations with our colleagues in the interdisciplinary emergency department (neurology and neurosurgery). The patient’s cranial computed tomography (CT) images, taken as part of the standard emergency routine, will be evaluated a second time. Sufficient explanation of the patient’s symptoms by CT and study compatibility will be discussed with the treating physician. In the case of an insufficient CT result, the patient will be informed about the study, the use of encoded (pseudonymised) data and the examination using magnet resonance imaging (MRI). The patient’s participation is limited to the MRI examinations, which will include both an accelerated (GOBrain, Siemens Healthineers, Erlangen, Germany) and a standard protocol. The standard and accelerated protocols will be performed in random order. Following the examination, a specialist will assess the results and record them in the radiological information system (RIS) for the treating physicians. All pathologies/observations will be documented. The CT and accelerated MRI protocol will be compared to the standard MRI protocol (reference standard). The investigation will compile data comparing the sensitivity and specificity, as well as rating the examination quality (1 - nondiagnostic, 2 - poor image quality and substantial artifacts, 3 - satisfactory, 4 - good image quality and minor artifacts, 5 - excellent image quality without artifacts) and gray-white matter differentiation (0 – no visible gray-white matter differentiation, 1 - unclear but recognizable borders, 2 - clear differentiation).

Primary Outcome(s)

The primary outcome of this study will be accomplished after the examination results have been assessed by a specialist and the sensitivities and specificities of the CT examination, accelerated MRI protocol and standard MRI protocol have been determined. The sensitivities and specificities of the CT examination, accelerated MRI protocol and standard MRI protocol (reference standard) will be compared and evaluated. We assume that the results of the standard and accelerated protocols will be virtually identical and the accelerated protocol will prove to be superior to CT.

Secondary Outcome(s)

Two blinded, independent readers will analyze all pseudonymised records. All pathologies/observations detected in the accelerated and standard MRI protocols will be recorded. Additionally, examination quality of the accelerated and standard MRI protocols will be assessed analogous to Prakkamukal et al. (J Neuroimaging 2016;26:503-510) (1 - nondiagnostic, 2 - poor image quality and substantial artifacts, 3 - satisfactory, 4 - good image quality and minor artifacts, 5 - excellent image quality without artifacts). Gray-white matter differentiation will also be assessed analogous to Prakkamukal et al. (0 – no visible gray-white matter differentiation, 1 - unclear but recognizable borders, 2 - clear differentiation).

Secondary ID(s)

interne Studiennummer

Source(s) of Monetary Support

Klinik und Poliklinik für Radiologie Klinikum der Universität München Campus Großhadern

Ethics review

Status: Approved
Approval date: 08/09/2017
Contact:

[e-mail]

Ethikkommission der Med. Fakultät der LMU

[phone]

[e-mail]

Results

• Results available: Yes
• Date Posted: 02/01/2024
• Date Completed: 30/01/2019
• URL: http://drks.de/search/en/trial/DRKS00013356#studyResults