Clinical Validation of BoneMRI in the Spine

Recruiting now

Conditions studied: Bone Diseases, Image, Medical Device

In brief

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.

Key facts

Study ID

NCT06745791

Run by

MRIguidance B.V.

People needed

450

Starts

2021-08-20

Expected to finish

2026-12-31

Last updated by the study team

2025-09-24

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥ 12 years old
• Indication for diagnostic MRI of the spine
• Indication for diagnostic CT of the spine
• Eligible for MRI
• Eligible for CT
• Written informed consent

You may not qualify if…

• 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

Where it is running

• Kantonsspital st. gallen — Sankt Gallen, Switzerland (enrolling)
• UZ Leuven — Leuven, Belgium (enrolling)
• VITAZ — Sint-Niklaas, Belgium (enrolling)
• Hopital saint joseph — Marseille, France (enrolling)
• UMC Utrecht — Utrecht, Utrecht, Netherlands (enrolling)
• Amsterdam UMC — Amsterdam, Netherlands (enrolling)
• UZ Gent — Ghent, Belgium (enrolling)
• Erasmus MC — Rotterdam, Netherlands (enrolling)
• Elisabeth Tweesteden Ziekenhuis — Tilburg, Netherlands (enrolling)
• Leids universitair medisch center — Leiden, Netherlands

Full record on ClinicalTrials.gov

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