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

Bone Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03633032
• Other study ID #: USZ_Radiationfree bone imaging
• Status: Completed
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: December 6, 2023

Study information

• Verified date: December 2023
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 6, 2023
• Est. primary completion date: December 6, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Bone Anatomy
• Bone Diseases

Intervention

Diagnostic Test:
• Acquiring of ultrashort echo time (UTE) MRI sequences
Modern MRI sequences (ultrashort echo time (UTE)) for a better depiction of bone anatomy

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
Roman Guggenberger

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.