No registrations found.
ID
Source
Brief title
Health condition
Symptoms related to a spine disorder with suspected underlying involvement of osseous structures
Sponsors and support
Intervention
Outcome measures
Primary outcome
Geometric accuracy in terms of visualization of the 3D osseous morphology of the spinal column.
Secondary outcome
Investigate the applicability of BoneMRI in specific applications for the spine.
Background 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.
This study is a prospective multi-center clinical validation study, following a comparative design.
Study objective
The BoneMRI technology is accurate in visualization of the osseous structures
Study design
After 1 year of inclusion the primary outcome will be assessed via an equivalency design. During this equivalency design the surface distance between the cortical edge of osseous structures as determined on a bone MRI and on a CT scan will be compared. The secondary endpoint will also be assessed after 1 year of inclusion via a survey that will be sent out to all of the end users of BoneMRI
Intervention
NA
Inclusion criteria
Subjects ≥ 18 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 criteria
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
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9570 |
| Other | METc UMCU : METC-20-801/D |