Radiation-free Bone Imaging UTE MRI in Healthy and Diseased Patients

Radiation-free Bone Imaging by Ultrashort Echo Time (UTE) Magnetic Resonance Tomography (MRT)

In summary, the investigators want to investigate whether UTE sequences are capable to replace imaging techniques involving ionizing radiation for bone imaging in the future. This would improve patient care greatly and might reduce medical imaging associated cancer risk drastically from an epidemiological standpoint. This field of research can be considered cutting-edge. The investigators determine this study promising to provide substantial generalizable knowledge and hope that this study results will improve patient care worldwide considerably.

Study Overview

• Status: Completed
• Conditions: Bone Diseases; Bone Anatomy
• Intervention / Treatment: Diagnostic test: Acquiring of ultrashort echo time (UTE) MRI sequences

Detailed Description

To date, definite depiction of anatomy or pathologies of bony structures requires ionizing radiation by using radiographs or computed tomography (CT) since conventional magnetic resonance imaging (MRI) that does not require ionizing radiation cannot depict bony structures well. Modern MR techniques, collectively referred to as ultrashort time to echo (UTE) sequences, have overcome this issue by acquiring the signal data much faster and therefore are able to acquire sufficient MR signal from bony structures. The investigators want to investigate if UTE sequences are capable to depict bony anatomy and pathology similar to imaging examination techniques involving ionizing radiation. Healthy adult and minor participants, as well as adult and minor participants, referred for a clinically indicated MRI involving the skeletal system will be included.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland
    • University Hospital Zurich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion criteria:

• adults and minors (all ages) capable of giving informed consent or have a legal representative capable of giving consent on the participant's behalf. Informed Consent as documented by signature (Appendix Informed Consent Form)
• for participants referred for a clinical indicated MRI (primary objective) inclusion criterion is the presence of radiographs or a CT scan of the part of the skeletal system that is under investigation within the clinical indicated MRI
• for healthy volunteers (secondary objective) any volunteer that is not referred for a clinical indicated MRI scan

Exclusion criteria:

• women who are pregnant
• general known contraindications for MRI (e.g., non-MR compatible pacemaker)
• homeless persons, or persons with active drug/alcohol dependence or abuse history

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: UTE MRI	Diagnostic test: Acquiring of ultrashort echo time (UTE) MRI sequences; Modern MRI sequences (ultrashort echo time (UTE)) for a better depiction of bone anatomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of the accuracy of bone anatomy size dimensions measurements between regular MRI and UTE MRI	Outcome measure 1 will be to compare the bone anatomy as visible on the radiation-free UTE images with the reference standard (pre-existing radiographs or CT) during readouts performed by radiologists. The measurements for the primary endpoint will specifically be: - size dimensions of the bony structures in three dimensions in millimeter	There is no baseline and follow-up examination for this study. The outcome measure will be assessed on the same day after the MRI examination is finished.
Comparison of the accuracy of cortical bone depiction between regular MRI and UTE MRI	Outcome measure 2 will be to compare the bone anatomy as visible on the radiation-free UTE images with the reference standard (pre-existing radiographs or CT) during readouts performed by radiologists. The measurements for the primary endpoint will specifically be - clearly visibility of the cortical bone according to a scale 1-4 (1 = cortical bone not good visible; 4 = cortical bone good visible)	There is no baseline and follow-up examination for this study. The outcome measure will be assessed on the same day after the MRI examination is finished.
Comparison of the accuracy of cancellous bone depiction between regular MRI and UTE MRI	Outcome measure 3 will be to compare the bone anatomy as visible on the radiation-free UTE images with the reference standard (pre-existing radiographs or CT) during readouts performed by radiologists. The measurements for the primary endpoint will specifically be - clearly visibility of the cancellous bone according to a scale 1-4 (1 = cancellous bone not good visible; 4 = cancellous bone good visible)	There is no baseline and follow-up examination for this study. The outcome measure will be assessed on the same day after the MRI examination is finished.
Comparison of the accuracy of calcification depiction between regular MRI and UTE MRI	Outcome measure 4 will be to compare the bone anatomy as visible on the radiation-free UTE images with the reference standard (pre-existing radiographs or CT) during readouts performed by radiologists. The measurements for the primary endpoint will specifically be - clearly visibility of calcifications according to a scale 1-4 (1 = calcification not good visible; 4 = calcification good visible)	There is no baseline and follow-up examination for this study. The outcome measure will be assessed on the same day after the MRI examination is finished.
Comparison of the diagnostic performance for depiction of bony anatomy between regular MRI and UTE MRI	Outcome measure 5 will be to compare the bone anatomy as visible on the radiation-free UTE images with the reference standard (pre-existing radiographs or CT) during readouts performed by radiologists. The measurements for the primary endpoint will specifically be: - diagnostic performance measurements for the depiction of bony anatomy (sensitivity, specificity, accuracy)	There is no baseline and follow-up examination for this study. The outcome measure will be assessed on the same day after the MRI examination is finished.
Comparison of the diagnostic confidence for depiction of bony anatomy between regular MRI and UTE MRI	Outcome measure 5 will be to compare the bone anatomy as visible on the radiation-free UTE images with the reference standard (pre-existing radiographs or CT) during readouts performed by radiologists. The measurements for the primary endpoint will specifically be: - diagnostic confidence measurements for the depiction of bony anatomy (1-4, 1=anatomical bony structure certainly absent, 4= certainly present)	There is no baseline and follow-up examination for this study. The outcome measure will be assessed on the same day after the MRI examination is finished.
Comparison of the Signal-to-noise (SNR) measurements between regular MRI and UTE MRI	Outcome measure 6 will be to compare the bone anatomy as visible on the radiation-free UTE images with the reference standard (pre-existing radiographs or CT) during readouts performed by radiologists. The measurements for the primary endpoint will specifically be: - Signal-to-noise (SNR)	There is no baseline and follow-up examination for this study. The outcome measure will be assessed on the same day after the MRI examination is finished.
Comparison of the Contrast-to-noise (CNR) measurements between regular MRI and UTE MRI	Outcome measure 7 will be to compare the bone anatomy as visible on the radiation-free UTE images with the reference standard (pre-existing radiographs or CT) during readouts performed by radiologists. The measurements for the primary endpoint will specifically be: - Contrast-to-noise (CNR)	There is no baseline and follow-up examination for this study. The outcome measure will be assessed on the same day after the MRI examination is finished.

Collaborators and Investigators

• Sponsor: Roman Guggenberger
• Investigators: Principal Investigator: Roman Guggenberger, MD, PD, Universitatsspital Zurich; Principal Investigator: Christian Kellenberger, MD, Kinderspital Zürich

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Actual): December 6, 2023
• Study Completion (Actual): December 6, 2023

Study Registration Dates

• First Submitted: July 12, 2018
• First Submitted That Met QC Criteria: August 14, 2018
• First Posted (Actual): August 16, 2018

Study Record Updates

• Last Update Posted (Actual): December 7, 2023
• Last Update Submitted That Met QC Criteria: December 6, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: bone imaging; MRI; UTE; radiation-free; ultrashort echo time ; anatomy
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Bone Diseases
• Other Study ID Numbers: USZ_Radiationfree bone imaging

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No