Clinical Validation of BoneMRI in the Spine

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12+
SponsorMRIguidance B.V.

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 volunteers

Qualifiers

≥ 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

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • BoneMRI

    Device

    BoneMRI 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

450 Participants
are divided into 1 treatment group
Group A: Spinal MRI and CT1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Expected duration: approximately 36-48 months to include 50 patients per MRI configuration.

Secondary outcomes

Other outcomes

Sponsors and contacts

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