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

NCT03633032 | Completed

• 1 other identifier: USZ_Radiationfree bone imaging
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone Anatomy; Bone Diseases

Keywords

bone imaging; MRI; UTE; radiation-free; ultrashort echo time ; anatomy

Outcome Measures

Primary Outcomes (8)

• 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.

Study Arms (1)

UTE MRI

OTHER

Diagnostic Test: Acquiring of ultrashort echo time (UTE) MRI sequences

Interventions

Acquiring of ultrashort echo time (UTE) MRI sequences DIAGNOSTIC_TEST

Modern MRI sequences (ultrashort echo time (UTE)) for a better depiction of bone anatomy

UTE MRI

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 healthy volunteers (secondary objective) any volunteer that is not referred for a clinical indicated MRI scan

You may not qualify if:

• 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

Sponsors & Collaborators

• Roman Guggenberger: lead

Study Sites (1)

University Hospital Zurich

Zurich, Switzerland

Location

MeSH Terms

Conditions

Bone Diseases

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases

Study Officials

• Roman Guggenberger, MD, PD

  Universitätsspital Zürich

  PRINCIPAL INVESTIGATOR

• Christian Kellenberger, MD

  Kinderspital Zürich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PD Dr. med. Roman Guggenberger, Sponsor-Investigator, Senior Physician, Institute of Diagnostic and Interventional Radiology, University Hospital Zurich, University of Zurich, Switzerland

Model Details: Bone anatomy will be compared between different imaging modalities

Study Record Dates

• First Submitted: July 12, 2018
• First Posted: August 16, 2018
• Study Start: October 1, 2018
• Primary Completion: December 6, 2023
• Study Completion: December 6, 2023
• Last Updated: December 7, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)