About this trial
BoneMRI is a quantitative 3D MRI technique that has been developed recently by MRIGuidance BV©, which is based on a multiple gradient-echo sequence and a machine learning processing pipeline. The BoneMRI technology is capable of generating CT-like, quantitative radiodensity bone MRI images to visualize cortical and trabecular bone, allowing to assess bone structure and morphology, in addition to regular clinical MRI images. The use of BoneMRI has been investigated and clinically validated in multiple musculoskeletal studies involving the cervical spine, hip and sacro-iliac joint. In order to clinically use BoneMRI in the entire spine, the BoneMRI technology needs to be validated in that area as well, focussing on geometrical and voxelwise accuracy of the radiodensity contrast to assure accurate visualization of the osseous structures. As robustness against expected data variability between hospitals is crucial for successful machine learning algorithms, multiple MR field strengths and scanner types from different manufacturers will be included in this study. If successful, BoneMRI will facilitate a better, easier and cheaper workflow by enabling diagnosis, treatment planning and surgical navigation using a single radiological examination, without the potential hazards of ionizing radiation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥ 12 years old
Indication for diagnostic MRI of the spine
Indication for diagnostic CT of the spine
Eligible for MRI
Disqualifiers
Pregnancy
History of (psychiatric) disorder which causes the patient to be incompetent to make a thought-out decision
claustrophobia
>3 months between CT and MRI scan
Trial population
Subjects referred to the radiology department for an MRI and CT scan of the spine having symptoms related to a spine disorder with suspected underlying involvement of osseous structures, will be asked to participate in this study.
Trial design
Other
Prospective
Treatments tested in this trial
BoneMRI
DeviceBoneMRI is a quantitative 3D MRI technique,capable of generating CT-like, quantitative radiodensity bone MRI images to visualize cortical and trabecular bone, allowing to assess bone structure and morphology, in addition to regular clinical MRI images.
Treatment groups
Trial outcomes
Primary outcomes
Accuracy of the BoneMRI image reconstructions in terms of tissue radiodensity and tissue radiodensity contrast (in HU), and 3D morphology (in mm)
The relevant outcome parameters defined for the BoneMRI application are related to the accurate reconstructions of tissue radiodensity, tissue radiodensity contrast and 3D morphology. The outcomes of geometrical (mm) and voxelwise (HU) accuracy of the radiodensity contrast assure accurate visualization of the osseous structures, in terms of visualization of the 3D osseous morphology of the spinal column. The following outcome parameters for BoneMRI are therefore defined: * Accuracy of the reconstruction of radiodensity and radiodensity contrast in Hounsfield Units (HU). * Accuracy of the 3D morphology of osseous structures in mm.
Sponsors and contacts
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