Prospective Study of Diagnostic Accuracy of Spectral CT for the Detection of Bone Marrow Edema (NCT04963127) | Clinical Trial Compass
UnknownNot Applicable
Prospective Study of Diagnostic Accuracy of Spectral CT for the Detection of Bone Marrow Edema
Germany800 participantsStarted 2021-07-15
Plain-language 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. 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Diagnostic Accuracy of Dual-Energy/Multi-Energy/Spectral CT to detect bone marrow edema in comparison with MRI as the goldstandard.
Timeframe: MRI of the same region can be used for comparison if performed within 7 days