Clinical Validation of BoneMRI in the Spine A Study to Assess BoneMRI Device Accuracy for Spine Bone Imaging

What this Trial Is About

Researchers are evaluating BoneMRI, a new 3D MRI technique developed by MRIGuidance BV, which creates CT-like images to show bone density and structure in the spine. This technology has been tested in other areas like the cervical spine, hip, and sacro-iliac joint, and now it needs to be validated for use in the entire spine. The study aims to confirm that BoneMRI accurately shows the shape and density of spinal bones, while working well across different hospitals and MRI machines from various manufacturers. The study involves using BoneMRI alongside regular MRI and CT scans of the spine. Patients already scheduled for these scans due to spine issues will undergo an additional BoneMRI sequence during their MRI appointment. The study compares BoneMRI images with CT scans to check accuracy in showing bone details without adding extra radiation exposure. This approach may allow future patients to have safer, faster, and less costly diagnoses and treatment planning using one MRI scan instead of multiple imaging tests. Participants will have both MRI and CT scans as part of their standard care, with the extra BoneMRI sequence added for research purposes. Researchers will assess the BoneMRI images for accuracy in bone density and 3D shape compared to CT scans. The study expects to include 50 patients per center over 36 to 48 months. There are no additional risks since BoneMRI images are not used for clinical decisions. The findings could help reduce the need for CT scans, lowering radiation exposure for future patients.

Clinical Validation of BoneMRI in the Spine