Validation of a new MRI technique for spinal bone imaging
Clinical Validation of BoneMRI in the Spine
This study is testing a new MRI technique called BoneMRI to see if it can provide clearer images of spinal bones, helping doctors diagnose issues without using radiation from CT scans.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 450 (estimated) |
| Ages | 12 Years and up |
| Sex | All |
| Sponsor | MRIguidance B.V. Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 10 sites (Ghent and 9 other locations) |
| Trial ID | NCT06745791 on ClinicalTrials.gov |
What this trial studies
This study aims to clinically validate BoneMRI, a novel quantitative 3D MRI technique developed by MRIGuidance BV©, for visualizing spinal bone structures. BoneMRI generates CT-like images that allow for detailed assessment of cortical and trabecular bone, enhancing the capabilities of standard MRI. The study will evaluate the accuracy of BoneMRI in visualizing osseous structures across various MR field strengths and scanner types to ensure robustness against data variability. By validating this technology for the entire spine, the study seeks to improve diagnostic workflows and reduce reliance on ionizing radiation from CT scans.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 12 and older who require diagnostic MRI or CT scans of the spine.
Not a fit: Patients who are pregnant, have claustrophobia, or have a history of psychiatric disorders that impair decision-making may not benefit from this study.
Why it matters
Potential benefit: If successful, this technology could provide a safer and more efficient method for diagnosing and planning treatment for spinal bone diseases.
How similar studies have performed: Previous studies have shown success with similar imaging techniques, but this specific application of BoneMRI for the spine is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Ghent and 9 other locations
- UZ Gent — Ghent, Belgium (Recruiting)
- UZ Leuven — Leuven, Belgium (Recruiting)
- Vitaz — Sint-Niklaas, Belgium (Recruiting)
- Hopital saint joseph — Marseille, France (Recruiting)
- UMC Utrecht — Utrecht, Utrecht, Netherlands (Recruiting)
- Amsterdam UMC — Amsterdam, Netherlands (Recruiting)
- Leids universitair medisch center — Leiden, Netherlands (Not_yet_recruiting)
- Erasmus MC — Rotterdam, Netherlands (Recruiting)
- Elisabeth Tweesteden Ziekenhuis — Tilburg, Netherlands (Recruiting)
- Kantonsspital st. gallen — Sankt Gallen, Switzerland (Recruiting)
Study contacts
- Study coordinator: Peter R Seevinck, dr. ir.
- Email: peter.seevinck@mriguidance.com
- Phone: 00316 81741711
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.