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

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ClinicalTrials.gov Identifier: NCT03633032
Recruitment Status : Not yet recruiting
First Posted : August 16, 2018
Last Update Posted : August 16, 2018
Sponsor:
Information provided by (Responsible Party):
Roman Guggenberger, University of Zurich

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.

Condition or disease Intervention/treatment Phase
Bone Anatomy Bone Diseases Diagnostic Test: Acquiring of ultrashort echo time (UTE) MRI sequences Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Bone anatomy will be compared between different imaging modalities
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Radiation-free Bone Imaging by Ultrashort Echo Time (UTE) Magnetic Resonance Tomography (MRT)
Estimated Study Start Date : October 2018
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine



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


Primary Outcome Measures :
  1. Comparison of the accuracy of bone anatomy size dimensions measurements between regular MRI and UTE MRI [ Time Frame: 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


  2. Comparison of the accuracy of cortical bone depiction between regular MRI and UTE MRI [ Time Frame: 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)


  3. Comparison of the accuracy of cancellous bone depiction between regular MRI and UTE MRI [ Time Frame: 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)


  4. Comparison of the accuracy of calcification depiction between regular MRI and UTE MRI [ Time Frame: 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)


  5. Comparison of the diagnostic performance for depiction of bony anatomy between regular MRI and UTE MRI [ Time Frame: 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)


  6. Comparison of the diagnostic confidence for depiction of bony anatomy between regular MRI and UTE MRI [ Time Frame: 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)


  7. Comparison of the Signal-to-noise (SNR) measurements between regular MRI and UTE MRI [ Time Frame: 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)


  8. Comparison of the Contrast-to-noise (CNR) measurements between regular MRI and UTE MRI [ Time Frame: 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)




Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03633032


Contacts
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Contact: Roman Guggenberger, MD, PD +41 44 255 29 00 roman.guggenberger@usz.ch

Sponsors and Collaborators
Roman Guggenberger
Investigators
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Principal Investigator: Roman Guggenberger, MD, PD Universitätsspital Zürich
Principal Investigator: Christian Kellenberger, MD Kinderspital Zürich

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Responsible Party: Roman Guggenberger, PD Dr. med. Roman Guggenberger, Sponsor-Investigator, Senior Physician, Institute of Diagnostic and Interventional Radiology, University Hospital Zurich, University of Zurich, Switzerland, University of Zurich
ClinicalTrials.gov Identifier: NCT03633032     History of Changes
Other Study ID Numbers: USZ_Radiationfree bone imaging
First Posted: August 16, 2018    Key Record Dates
Last Update Posted: August 16, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Keywords provided by Roman Guggenberger, University of Zurich:
bone imaging; MRI; UTE; radiation-free; ultrashort echo time ; anatomy

Additional relevant MeSH terms:
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Bone Diseases
Musculoskeletal Diseases