Bone AnatomyNCT03633032
Radiation-free Bone Imaging UTE MRI in Healthy and Diseased Patients
A study testing Acquiring of ultrashort echo time (UTE) MRI sequences in people with Bone Anatomy and Bone Diseases, run by Roman Guggenberger at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Bone Anatomy, Bone Diseases
- What is being tested?
- Acquiring of ultrashort echo time (UTE) MRI sequences
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Oct 2018to 6 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Radiation-free Bone Imaging by Ultrashort Echo Time (UTE) Magnetic Resonance Tomography (MRT)
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.
Read the 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.
- Conditions
- Bone Anatomy, Bone Diseases
- Being tested
- Acquiring of ultrashort echo time (UTE) MRI sequences
- Keywords
- bone imaging; MRI; UTE; radiation-free; ultrashort echo time ; anatomy
- Medical subject headings
- Bone Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acquiring of ultrashort echo time (UTE) MRI sequencesDiagnostic test
Modern MRI sequences (ultrashort echo time (UTE)) for a better depiction of bone anatomy
| Study group | Role | What they receive |
|---|---|---|
| UTE MRI | Other | Not described Receives: Diagnostic Test: Acquiring of ultrashort echo time (UTE) MRI sequences |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2018
- Study start1 Oct 2018
- Primary completion6 Dec 2023
- Study completion6 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone AnatomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Bone anatomy will be compared between different imaging modalities
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roman Guggenberger
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Roman Guggenberger, University of Zurich
- Investigators
- Roman Guggenberger, MD, PD, Principal investigator, Universitätsspital ZürichChristian Kellenberger, MD, Principal investigator, Kinderspital Zürich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03633032
- Sponsor's protocol ID
- USZ_Radiationfree bone imaging
- Status last verified
- Dec 2023
- First submitted
- 12 Jul 2018
- Last updated
- 7 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiation-free Bone Imaging by Ultrashort Echo Time (UTE) Magnetic Resonance Tomography (MRT)
- ClinicalTrials.gov ID
- NCT03633032
- Acronym / sponsor ID
- USZ_Radiationfree bone imaging
- Conditions
- Bone Anatomy, Bone Diseases
- Keywords
- bone imaging; MRI; UTE; radiation-free; ultrashort echo time ; anatomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Roman GuggenbergerUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 6 Dec 2023 (actual)
- Study completion
- 6 Dec 2023 (actual)
- First posted
- 16 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Bone anatomy will be compared between different imaging modalities
| Arm | Type | Receives |
|---|---|---|
| UTE MRI | Other | Diagnostic Test: Acquiring of ultrashort echo time (UTE) MRI sequences |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acquiring of ultrashort echo time (UTE) MRI sequencesModern MRI sequences (ultrashort echo time (UTE)) for a better depiction of bone anatomy | Diagnostic test | UTE MRI |
Primary outcome
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
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)
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)
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)
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)
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roman Guggenberger, MD, PD principal investigator
Universitätsspital Zürich
Christian Kellenberger, MD principal investigator
Kinderspital Zürich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acquiring of ultrashort echo time (UTE) MRI sequences in people with Bone Anatomy and Bone Diseases, run by Roman Guggenberger at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2023.