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

Back to results

Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

Switzerland

Study Type

Interventional

Intervention

Acquiring of ultrashort echo time (UTE) MRI sequences

About this trial

This is an interventional diagnostic trial for Bone Anatomy focused on measuring bone imaging; MRI; UTE; radiation-free; ultrashort echo time ; anatomy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

University Hospital ZurichRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

UTE MRI

Arm Description

Outcomes

Primary Outcome Measures

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

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)

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)

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)

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)

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)

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)

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)

Secondary Outcome Measures

Full Information

NCT ID

NCT03633032

First Posted

July 12, 2018

Last Updated

November 1, 2022

Sponsor

Roman Guggenberger

1. Study Identification

Unique Protocol Identification Number

NCT03633032

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Recruiting

Study Start Date

October 1, 2018 (Actual)

Primary Completion Date

August 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Roman Guggenberger

4. Oversight

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

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bone Anatomy, Bone Diseases

Keywords

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

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Bone anatomy will be compared between different imaging modalities

Masking

None (Open Label)

Allocation

N/A

Enrollment

1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

UTE MRI

Arm Type

Other

Intervention Type

Diagnostic Test

Intervention Name(s)

Acquiring of ultrashort echo time (UTE) MRI sequences

Intervention Description

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

Primary Outcome Measure Information:

Title

Comparison of the accuracy of bone anatomy size dimensions measurements between regular MRI and UTE MRI

Description

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

Time Frame