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

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 design

Treatments tested in this trial

  • BoneMRI

Treatment groups

450 Participants
are divided into 1 treatment group

Sponsors and collaborators