Clinical trial NCT03633032: 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
Overall status: COMPLETED
Phase: NA
Conditions: Bone Anatomy
Bone Diseases
Keywords: bone imaging; MRI; UTE; radiation-free; ultrashort echo time ; anatomy
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2018-08-16
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Bone anatomy will be compared between different imaging modalities
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Comparison of the accuracy of bone anatomy size dimensions measurements between regular MRI and UTE MRI
timeFrame: 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.
measure: Comparison of the accuracy of cortical bone depiction between regular MRI and UTE MRI
timeFrame: 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.
measure: Comparison of the accuracy of cancellous bone depiction between regular MRI and UTE MRI
timeFrame: 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.
measure: Comparison of the accuracy of calcification depiction between regular MRI and UTE MRI
timeFrame: 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.
measure: Comparison of the diagnostic performance for depiction of bony anatomy between regular MRI and UTE MRI
timeFrame: 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.
measure: Comparison of the diagnostic confidence for depiction of bony anatomy between regular MRI and UTE MRI
timeFrame: 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.
measure: Comparison of the Signal-to-noise (SNR) measurements between regular MRI and UTE MRI
timeFrame: 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.
measure: Comparison of the Contrast-to-noise (CNR) measurements between regular MRI and UTE MRI
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich
Study officials:
affiliation: Universitätsspital Zürich
name: Roman Guggenberger, MD, PD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kinderspital Zürich
name: Christian Kellenberger, MD
role: PRINCIPAL_INVESTIGATOR
References: