Clinical Validation of BoneMRI in the Spine

NCT06745791 | Recruiting

• 1 other identifier: CIP 005 spine multicenter
• Study Type: observational
• Target: 450
• Locations: 4 countries
• Sites: 10

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.

Conditions

Bone Diseases; Image; Medical Device

Keywords

medical device; software; synthetic CT; MRI sequence

Outcome Measures

Primary Outcomes (1)

• Accuracy of the BoneMRI image reconstructions in terms of tissue radiodensity and tissue radiodensity contrast (in HU), and 3D morphology (in mm)

  The relevant outcome parameters defined for the BoneMRI application are related to the accurate reconstructions of tissue radiodensity, tissue radiodensity contrast and 3D morphology. The outcomes of geometrical (mm) and voxelwise (HU) accuracy of the radiodensity contrast assure accurate visualization of the osseous structures, in terms of visualization of the 3D osseous morphology of the spinal column. The following outcome parameters for BoneMRI are therefore defined: * Accuracy of the reconstruction of radiodensity and radiodensity contrast in Hounsfield Units (HU). * Accuracy of the 3D morphology of osseous structures in mm.

  Expected duration: approximately 36-48 months to include 50 patients per MRI configuration.

Study Arms (1)

Spinal MRI and CT

Subjects referred to the radiology department for an MRI and CT scan of the spine having symptoms related to a spine disorder with suspected underlying involvement of osseous structures, will be asked to participate in this study.

Device: BoneMRI

Interventions

BoneMRI DEVICE

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.

Spinal MRI and CT

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects referred to the radiology department for an MRI and CT scan of the spine having symptoms related to a spine disorder with suspected underlying involvement of osseous structures, will be asked to participate in this study.

You may qualify if:

• ≥ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MRIguidance B.V.: lead

Study Sites (10)

UZ Gent

Ghent, 9000, Belgium

RECRUITING

UZ Leuven

Leuven, 3000, Belgium

RECRUITING

VITAZ

Sint-Niklaas, 9100, Belgium

RECRUITING

Hopital saint joseph

Marseille, 13008, France

RECRUITING

UMC Utrecht

Utrecht, Utrecht, 3584 CX, Netherlands

RECRUITING

Amsterdam UMC

Amsterdam, 1105AZ, Netherlands

RECRUITING

Leids universitair medisch center

Leiden, 2333ZA, Netherlands

NOT YET RECRUITING

Erasmus MC

Rotterdam, 3015 GD, Netherlands

RECRUITING

Elisabeth Tweesteden Ziekenhuis

Tilburg, 5022GC, Netherlands

RECRUITING

Kantonsspital st. gallen

Sankt Gallen, 9007, Switzerland

RECRUITING

MeSH Terms

Conditions

Bone Diseases

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases

Study Officials

• Peter R Seevinck, dr. ir.

  iCEO, Founder

  STUDY DIRECTOR

Central Study Contacts

Peter R Seevinck, dr. ir.

CONTACT

00316 81741711; peter.seevinck@mriguidance.com

Hilde Geraedts, phd

CONTACT

clinical@mriguidance.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2024
• First Posted: December 20, 2024
• Study Start: August 20, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 24, 2025

Record last verified: 2025-09

Locations

BE (3); FR (1); NL (5); CH (1)