Prospective Study of Diagnostic Accuracy of Spectral CT for the Detection of Bone Marrow Edema

University Hospital Augsburg

Status: Enrolling

Conditions: Bone Marrow Edema; Fractures, Bone

Treatments: Diagnostic Test: Computed Tomography of the skeleton using a Dual-Energy-/Multi-Energy-/Spectral acquisition mode; Diagnostic Test: Computed Tomography of the skeleton using a conventional single-energy / non-spectral acquisition mode

Study type: Observational

Funder types: Other

Identifiers

NCT04963127

21-0318

Details and patient eligibility

About

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.

Enrollment: 800 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

800 participants in 2 patient groups

Prospective Cohort

Description:

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.

Treatment:

Diagnostic Test: Computed Tomography of the skeleton using a Dual-Energy-/Multi-Energy-/Spectral acquisition mode

Retrospective Cohort

Description:

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.

Treatment:

Diagnostic Test: Computed Tomography of the skeleton using a conventional single-energy / non-spectral acquisition mode