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

Not Applicable

Completed

• Conditions: Bone Anatomy; Bone Diseases
• Interventions: Diagnostic Test: Acquiring of ultrashort echo time (UTE) MRI sequences

• Registration Number: NCT03633032
• Lead Sponsor: Roman Guggenberger

Brief Summary

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.

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 Timeline

• Study First Submitted: 2018-07-12
• Study First Submitted QC: 2018-08-14
• Study First Posted: 2018-08-16
• Study Start: 2018-10-01
• Status Verified: 2023-12
• Primary Completion: 2023-12-06
• Study Completion: 2023-12-06
• Last Update Submitted: 2023-12-06
• Last Update Posted: 2023-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
UTE MRI	Acquiring of ultrashort echo time (UTE) MRI sequences	-

Primary Outcome Measures

Name	Time	Method
Comparison of the accuracy of bone anatomy size dimensions measurements between regular MRI and UTE MRI	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.	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
Comparison of the accuracy of cortical bone depiction between regular MRI and UTE MRI	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.	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)
Comparison of the accuracy of cancellous bone depiction between regular MRI and UTE MRI	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.	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)
Comparison of the accuracy of calcification depiction between regular MRI and UTE MRI	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.	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)
Comparison of the diagnostic performance for depiction of bony anatomy between regular MRI and UTE MRI	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.	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)
Comparison of the diagnostic confidence for depiction of bony anatomy between regular MRI and UTE MRI	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.	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)
Comparison of the Signal-to-noise (SNR) measurements between regular MRI and UTE MRI	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.	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)
Comparison of the Contrast-to-noise (CNR) measurements between regular MRI and UTE MRI	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.	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)

Trial Locations

Locations (1)

University Hospital Zurich; 🇨🇭 Zurich, Switzerland