What is this study trying to find out about bone diseases in the spine?

This study is evaluating BoneMRI, a new imaging technique that creates detailed 3D pictures of spinal bones using MRI. Researchers want to see if BoneMRI can accurately show bone structure compared to standard CT scans, which use radiation. This research may help improve spine diagnosis and treatment while reducing radiation exposure.

Who may be eligible for this bone diseases clinical trial?

People 12 years and older with a medical need for both MRI and CT scans of the spine may be eligible. Participants must be able to safely undergo these scans and provide informed consent. Anyone who is pregnant, has claustrophobia, or has certain mental health conditions may not qualify. Please review eligibility criteria for more details.

Is there any cost to participate in this bone diseases clinical trial?

Study-related care, including the study procedure and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should plan for any travel costs themselves.

Actively Recruiting

Age: 12Years +

All Genders

ID06745791

Clinical Validation of BoneMRI in the Spine to Assess Spinal Bone Structure Using 3D MRI Compared to CT

Led by MRIguidance B.V. · Updated on 2025-09-24

450

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating BoneMRI, a new 3D MRI technique developed by MRIGuidance BV, which creates CT-like images to visualize bone structure and morphology in the spine. This study aims to validate BoneMRIs accuracy in showing spinal bone details, focusing on how well it measures radiodensity and 3D shape across different hospital scanners and MRI machines. The goal is to improve diagnosis and treatment planning while reducing exposure to ionizing radiation. The study involves patients who are referred for both MRI and CT scans of the spine due to suspected bone-related spine disorders. Participants will have an additional MRI sequence taken using BoneMRI technology, alongside their routine scans. This prospective multi-center study expects to include 50 patients per center over 36 to 48 months. BoneMRI images will be compared to standard CT images to assess accuracy and reliability across various MRI configurations. During the study, participants will undergo routine clinical MRI and CT scans as part of their standard care, with the extra BoneMRI sequence added for research purposes. Researchers will measure how accurately BoneMRI reconstructs tissue radiodensity and 3D spinal morphology. There are no additional risks since BoneMRI images are not used in patient care decisions. The study may help reduce future patients radiation exposure if BoneMRI proves accurate enough to replace some CT scans.

CONDITIONS

Brief Title

Clinical Validation of BoneMRI in the Spine

Who Can Participate

Age: 12Years +

All Genders

Eligibility Criteria

You may qualify if you...

12 years old or older
Medical need for diagnostic MRI of the spine
Medical need for diagnostic CT of the spine
Eligible for MRI
Eligible for CT
Provided written informed consent

You will not qualify if you...

Pregnancy
History of psychiatric disorder affecting decision-making ability
Claustrophobia
More than 3 months between CT and MRI scans

Research Team

Peter R Seevinck, dr. ir.

Hilde Geraedts, phd

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