Fractures, BoneNCT04963127
Prospective Study of Diagnostic Accuracy of Spectral CT for the Detection of Bone Marrow Edema
An observational study of Fractures, Bone and Bone Marrow Edema, run by University Hospital Augsburg at 1 site in Germany.
Trial summary
Dual-Energy/Multi-Energy/Spectral-CT can visualize bone marrow edema associated with fractures, however, current scientific evidence is mostly derived from to retrospective analyses. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fractures, Bone, Bone Marrow Edema
- What is being tested?
- Computed Tomography of the skeleton using a Dual-Energy-/Multi-Energy-/Spectral acquisition mode and Computed Tomography of the skeleton using a conventional single-energy / non-spectral acquisition mode
- How many people
- 800 participants
- Where
- 1 siteGermany
- Study dates
- 15 Jul 2021to 31 May 2025
- How long will I take part?
- 7 Days
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are at least 18 years of age who are referred by the emergency department for a CT scan with the suspicion of a fracture.
Who may be able to join
- clinical suspicion for a fracture AND
- indication for CT confirmed by board-certified radiologist ('justified indication' according to German/European radiation protection law) AND
- patient (is able to give informed consent and) has given informed consent.
Who cannot join
- cardiorespiratory instability (as judged by the referring physician)
- age < 18 years
- known or suspected pregnancy
- known bone metastases of a malignant disease
- known rheumatic disease
- metal implants in the region to be scanned
- surgical intervention over the last 12 months in the region to be scanned
- contraindications for MRI
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Augsburg
Augsburg, Bavaria, 86156
Florian Schwarz, MD, +498214002441, radiologie-studien@uk-augsburg.de
About this study
Official title: Prospective Observational Study of Diagnostic Accuracy of Dual-Energy-/Multi-Energy-CT for the Detection of Bone Marrow Edema
Dual-Energy/Multi-Energy/Spectral-CT can visualize bone marrow edema associated with fractures, however, current scientific evidence is mostly derived from to retrospective analyses. Our prospective study systematically analyzes the diagnostic accuracy of the visualization of bone marrow edema by including patients who are scheduled for a CT scan to exclude or further characterize a fracture. After giving informed consent, the CT scan will be performed using a dose-neutral Dual-Energy-/Multi-Energy-/Spectral-CT acquisition technique. If the patient undergoes MRI of the same region within 7 days, this scan will be used as a gold-standard for bone marrow edema. This will allow the quantification of diagnostic accuracy.
- Conditions
- Fractures, Bone, Bone Marrow Edema
- Being tested
- Computed Tomography of the skeleton using a Dual-Energy-/Multi-Energy-/Spectral acquisition mode, Computed Tomography of the skeleton using a conventional single-energy / non-spectral acquisition mode
- Keywords
- Spectral CT, Multi-Energy CT, Dual-Energy CT, Bone Marrow Edema
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computed Tomography of the skeleton using a Dual-Energy-/Multi-Energy-/Spectral acquisition modeDiagnostic test
Also called Spectral Imaging
CT acquisition using a Dual-Energy / Multi-Energy / Spectral acquisition mode
Computed Tomography of the skeleton using a conventional single-energy / non-spectral acquisition modeDiagnostic test
CT acquisition using a standard single energy / non-spectral acquisition mode
| Study group | Role | What they receive |
|---|---|---|
| Prospective Cohort | 400 patients who are scheduled to undergo a clinically requested CT scan of parts of the skeleton using a Dual-Energy/Multi-Energy/Spectral acquisition mode to exclude or further define bone fractures. Receives: Diagnostic Test: Computed Tomography of the skeleton using a Dual-Energy-/Multi-Energy-/Spectral acquisition mode | |
| Retrospective Cohort | 400 patients who had undergone a clinically requested CT scan of the skeleton in standard acquisition mode in the past to exclude or further define bone fractures. Receives: Diagnostic Test: Computed Tomography of the skeleton using a conventional single-energy / non-spectral acquisition mode |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Accuracy of Dual-Energy/Multi-Energy/Spectral CT to detect bone marrow edema in comparison with MRI as the goldstandard.
sensitivity, specificity and positive and negative likelihood ratios will be assessed
Measured: MRI of the same region can be used for comparison if performed within 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2021
- Study start15 Jul 2021
- Primary completion31 May 2025 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fractures, BoneStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 800 participants (estimated)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- University Hospital Augsburg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Schwarz, MD, Principal investigator, University Hospital Augsburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04963127
- Sponsor's protocol ID
- 21-0318
- Status last verified
- Nov 2023
- First submitted
- 5 Jul 2021
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to share individual participant data upon request (pending final approval by the data protection officer of the university hospital).
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study of Diagnostic Accuracy of Dual-Energy-/Multi-Energy-CT for the Detection of Bone Marrow Edema
- ClinicalTrials.gov ID
- NCT04963127
- Acronym / sponsor ID
- 21-0318
- Conditions
- Fractures, Bone, Bone Marrow Edema
- Keywords
- Spectral CT, Multi-Energy CT, Dual-Energy CT, Bone Marrow Edema
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- University Hospital AugsburgUniversity, hospital or other
- Study start
- 15 Jul 2021 (actual)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 15 Jul 2021 (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.
Dual-Energy/Multi-Energy/Spectral-CT can visualize bone marrow edema associated with fractures, however, current scientific evidence is mostly derived from to retrospective analyses. Our prospective study systematically analyzes the diagnostic accuracy of the visualization of bone marrow edema by including patients who are scheduled for a CT scan to exclude or further characterize a fracture. After giving informed consent, the CT scan will be performed using a dose-neutral Dual-Energy-/Multi-Energy-/Spectral-CT acquisition technique. If the patient undergoes MRI of the same region within 7 days, this scan will be used as a gold-standard for bone marrow edema. This will allow the quantification of diagnostic accuracy.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 7 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prospective Cohort | – | Diagnostic Test: Computed Tomography of the skeleton using a Dual-Energy-/Multi-Energy-/Spectral acquisition mode400 patients who are scheduled to undergo a clinically requested CT scan of parts of the skeleton using a Dual-Energy/Multi-Energy/Spectral acquisition mode to exclude or further define bone fractures. |
| Retrospective Cohort | – | Diagnostic Test: Computed Tomography of the skeleton using a conventional single-energy / non-spectral acquisition mode400 patients who had undergone a clinically requested CT scan of the skeleton in standard acquisition mode in the past to exclude or further define bone fractures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are at least 18 years of age who are referred by the emergency department for a CT scan with the suspicion of a fracture.
Key inclusion criteria (3 listed)
- clinical suspicion for a fracture AND
- indication for CT confirmed by board-certified radiologist ('justified indication' according to German/European radiation protection law) AND
- patient (is able to give informed consent and) has given informed consent.
Key exclusion criteria (8 listed)
- cardiorespiratory instability (as judged by the referring physician)
- age < 18 years
- known or suspected pregnancy
- known bone metastases of a malignant disease
- known rheumatic disease
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 |
|---|---|---|
| Computed Tomography of the skeleton using a Dual-Energy-/Multi-Energy-/Spectral acquisition modeAlso: Spectral ImagingCT acquisition using a Dual-Energy / Multi-Energy / Spectral acquisition mode | Diagnostic test | Prospective Cohort |
| Computed Tomography of the skeleton using a conventional single-energy / non-spectral acquisition modeCT acquisition using a standard single energy / non-spectral acquisition mode | Diagnostic test | Retrospective Cohort |
Primary outcome
Diagnostic Accuracy of Dual-Energy/Multi-Energy/Spectral CT to detect bone marrow edema in comparison with MRI as the goldstandard.
Time frame: MRI of the same region can be used for comparison if performed within 7 days
sensitivity, specificity and positive and negative likelihood ratios will be assessed
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Individual participant dataSharing planned: Yes. We plan to share individual participant data upon request (pending final approval by the data protection officer of the university hospital).
Related trials for Fractures, Bone
Not yet recruiting
Biodegradable Magnesium Screws for Unstable Ankle Fracture Surgery
Ankle Fractures, Syndesmotic Injury
Active, not recruitingObservational study
The Developmental Origins of Suicide Mortality
Suicide Mortality
RecruitingObservational study
Duration of Immobilization After Reverse Total Arthroplasty for Proximal Humerus Fractures
Proximal Humeral Fracture, Reverse Total Shoulder Arthroplasty
Recruiting
No Reduction Compared to Closed Reduction for Distal Radius Fractures in Patients Over 65 or Older
Distal Radius Fracture, Casting
RecruitingObservational study
A Clinical Study to Collect Real-wordt Data on Safety and Clinical Performance of the VCFix Spinal System for Treatment of Vertebral Compression Fractures of (Suspected) Osteoporotic Origin.
Vertebra Compression Fracture
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.
Schwarz, MD principal investigator
University Hospital Augsburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fractures, Bone and Bone Marrow Edema, run by University Hospital Augsburg at 1 site in Germany.
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 8 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: status not confirmed, as of the sponsor's last update on 22 Nov 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Schwarz, MD (+498214002441, radiologie-studien@uk-augsburg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Accuracy of Dual-Energy/Multi-Energy/Spectral CT to detect bone marrow edema in comparison with MRI as the goldstandard. (time frame: MRI of the same region can be used for comparison if performed within 7 days). 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 22 Nov 2023.