Evaluating the accuracy of Spectral CT in detecting bone marrow edema
Prospective Observational Study of Diagnostic Accuracy of Dual-Energy-/Multi-Energy-CT for the Detection of Bone Marrow Edema
This study is testing if a new type of CT scan can better spot bone marrow swelling in people who have fractures compared to the standard MRI.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 800 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital Augsburg Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Augsburg, Bavaria) |
| Trial ID | NCT04963127 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the diagnostic accuracy of Spectral CT in visualizing bone marrow edema associated with fractures. Patients scheduled for a CT scan to evaluate a fracture will undergo both a Dual-Energy/Multi-Energy/Spectral CT scan and, if applicable, an MRI within 7 days, which will serve as the gold standard for comparison. The study will systematically analyze the data to quantify the effectiveness of Spectral CT in detecting bone marrow edema. This approach addresses the gap in current evidence, which is primarily based on retrospective analyses.
Who should consider this trial
Good fit: Ideal candidates include adults with a clinical suspicion of a fracture who are scheduled for a CT scan.
Not a fit: Patients under 18, those with cardiorespiratory instability, or contraindications for MRI will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the diagnostic capabilities for detecting bone marrow edema, leading to better management of fractures.
How similar studies have performed: While there is limited evidence from prospective studies, previous research has shown promise in using Spectral CT for similar diagnostic purposes.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Augsburg, Bavaria
- University Hospital Augsburg — Augsburg, Bavaria, Germany (Recruiting)
Study contacts
- Principal investigator: Schwarz, MD — University Hospital Augsburg
- Study coordinator: Schwarz, MD
- Email: radiologie-studien@uk-augsburg.de
- Phone: +498214002441
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.