German Clinical Trials Register

Acronym/abbreviation of the study

Ultrafast Brain MRI in Acute Neurological Emergencies: the FAMILIES trial (LMU-RAD00055)

URL of the study

No Entry

Brief summary in lay language

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).

Brief summary in scientific language

Acute pathologies of the central nervous system are one of the most common reasons for an admission to an emergency department. Besides past medical history and the physical examination, prompt imaging procedures of the head are important to detect possible intracranial pathologies. The computed tomography (CT) of the head is an essential part of neurological emergency diagnostics. CT offers time efficient examinations and is widely spread in hospitals around the world. It is well suited to display high contrast structures (e.g. bones, air). However, alterations in low contrast structures (e.g. central nervous system) can often only be observed when they are very distinct. Alterations include hemorrhage, ischemia, edema, infarction and increased intracranial pressure (ICP). Therefore, CT is suboptimal for detailed diagnostics and differential diagnosis. The head MRI has distinct advantages during neurological emergency diagnostics, because of its higher soft tissue contrast and therefore superior diagnostic accuracy. However, the use of the head MRI for neurological emergency situations is limited because the examination procedure requires too much time (> 20 min for a standard head MRI protocol). To be able to make fast and precise therapy decisions, it is very important to have a fast, high resolution head imaging program. This study will evaluate a new head MRI protocol (GOBrain, Siemens Healthineers, Erlangen, Germany) which will reduce the standard head MRI examination time from 20 min to 5 min. The reduced acquisition time with this protocol may enable the use of the head MRI for acute emergency diagnostics. The prerequisite is that the accelerated MRI protocol will have to demonstrate an equivalent or better diagnostic value compared to standard MRI protocols. The goal of this study is to demonstrate the practicability and diagnostic value of the accelerated head MRI protocol in comparison to standard head MRI protocols, as well as CT head protocols.