The objective of this study is to investigate whether Bone MRI can be used for the 3D visualization and characterization of bone.
ID
Source
Brief title
Condition
- Bone disorders (excl congenital and fractures)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Objective and subjective image quality of Bone MRI will be investigated.
Geometrical accuracy and voxelwise similarity will be assessed to evaluate
objective image quality and will be leading in the acceptance of Bone MRI
images.
Secondary outcome
Subjective image scores is our secondary outcome measure. Bone MRI scans will
be assessed by two radiologists and one neurosurgeon and should reach a score
of 3 or higher (scale 1-4) in 80% in order to be qualified as acceptable, in
the rating of predetermined anatomical structures.
Background summary
Magnetic Resonance Imaging (MRI) is frequently used in the evaluation of
symptoms referring to diseases of the cervical spine, such as radiculopathy.
MRI offers excellent soft-tissue visualization without the use of ionizing
radiation. CT can be very useful as an adjunct to MRI to assess osseous
involvement of disease. International literature has not yet reached consensus
about the best diagnostic strategy in osseous conditions of the cervical spine.
Recently, Bone MRI was developed, a quantitative MRI technique by MRI Guidance
BV©, which is based on a multiple gradient-echo sequence and a machine learning
processing pipeline and is capable of generating CT-like quantitative bone MRI
images. The use of Bone MRI is currently investigated in multiple
musculoskeletal studies. If successful, future patients can benefit from better
diagnostic techniques, without the potential hazards of ionizing radiation.
Study objective
The objective of this study is to investigate whether Bone MRI can be used for
the 3D visualization and characterization of bone.
Study design
This study is a prospective single-centre feasibility and validation study.
Patients referred to the Radiology Department for a MRI scan of the cervical
spine, will be asked to participate in this study. After written informed
consent is obtained, patients will receive an extra MRI sequence in addition to
the standard MRI scan and an additional CT of the cervical spine.
Study burden and risks
The patient does not benefit from participating in this study and will receive
routine care. For research purposes an additional MRI sequence and CT scan of
the cervical spine will be obtained for each patient. Patients are exposed to a
low amount of ionizing radiation (1 mSv); this is nearly 40% of the yearly
natural background radiation dose and low compared to other computed tomography
studies. This study may contribute to a lower radiation dose in future
patients: if Bone MRI images are sufficient for assessing osseous structures of
the cervical spine, an additional CT scan will become redundant.
Dokter van Heesweg 2
Zwolle 8025 AB
NL
Dokter van Heesweg 2
Zwolle 8025 AB
NL
Listed location countries
Age
Inclusion criteria
- Subjects * 50 years old
- Indication for MRI cervical spine
- Eligible for MRI
- Written informed consent
- Able to read in Dutch
Exclusion criteria
- Not eligible for MRI
- Previous participation in the study
- Pregnancy
- Concomitant participation in a research project in which the patient is exposed to ionizing radiation
- History of osteosynthesis of the cervical spine
- History of (psychiatric) disorder which causes the patient to be incompetent to make a thought-out decision.
Design
Recruitment
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 |
|---|---|
| CCMO | NL65041.075.18 |