NCT06745791 Clinical Validation of BoneMRI in the Spine
| NCT ID | NCT06745791 |
| Status | Recruiting |
| Phase | — |
| Sponsor | MRIguidance B.V. |
| Condition | Bone Diseases |
| Study Type | OBSERVATIONAL |
| Enrollment | 450 participants |
| Start Date | 2021-08-20 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 450 participants in total. It began in 2021-08-20 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * ≥ 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 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
Contact & Investigator
Peter R Seevinck, dr. ir.
STUDY DIRECTOR
iCEO, Founder
Frequently Asked Questions
Who can join the NCT06745791 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, studying Bone Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06745791 currently recruiting?
Yes, NCT06745791 is actively recruiting participants. Contact the research team at peter.seevinck@mriguidance.com for enrollment information.
Where is the NCT06745791 trial being conducted?
This trial is being conducted at Ghent, Belgium, Leuven, Belgium, Sint-Niklaas, Belgium, Marseille, France and 6 additional locations.
Who is sponsoring the NCT06745791 clinical trial?
NCT06745791 is sponsored by MRIguidance B.V.. The principal investigator is Peter R Seevinck, dr. ir. at iCEO, Founder. The trial plans to enroll 450 participants.