RecruitingNCT06745791

Clinical Validation of BoneMRI in the Spine


Sponsor

MRIguidance B.V.

Enrollment

450 participants

Start Date

Aug 20, 2021

Study Type

OBSERVATIONAL

Conditions

Summary

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

Min Age: 12 Years

Inclusion Criteria6

  • ≥ 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

Exclusion Criteria4

  • 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

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Interventions

DEVICEBoneMRI

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.


Locations(10)

UZ Gent

Ghent, Belgium

UZ Leuven

Leuven, Belgium

VITAZ

Sint-Niklaas, Belgium

Hopital saint joseph

Marseille, France

UMC Utrecht

Utrecht, Utrecht, Netherlands

Amsterdam UMC

Amsterdam, Netherlands

Leids universitair medisch center

Leiden, Netherlands

Erasmus MC

Rotterdam, Netherlands

Elisabeth Tweesteden Ziekenhuis

Tilburg, Netherlands

Kantonsspital st. gallen

Sankt Gallen, Switzerland

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NCT06745791


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