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

NCT04963127 | Unknown

• 1 other identifier: 21-0318
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fractures, Bone; Bone Marrow Edema

Keywords

Spectral CT; Multi-Energy CT; Dual-Energy CT; Bone Marrow Edema

Outcome Measures

Primary Outcomes (1)

• 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

  MRI of the same region can be used for comparison if performed within 7 days

Study Arms (2)

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.

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.

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

Interventions

Computed Tomography of the skeleton using a Dual-Energy-/Multi-Energy-/Spectral acquisition mode DIAGNOSTIC_TEST

CT acquisition using a Dual-Energy / Multi-Energy / Spectral acquisition mode

Also known as: Spectral Imaging

Prospective Cohort

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

CT acquisition using a standard single energy / non-spectral acquisition mode

Retrospective Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Augsburg: lead

Study Sites (1)

University Hospital Augsburg

Augsburg, Bavaria, 86156, Germany

RECRUITING

MeSH Terms

Conditions

Fractures, Bone

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Schwarz, MD

  University Hospital Augsburg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Schwarz, MD

CONTACT

+498214002441; radiologie-studien@uk-augsburg.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2021
• First Posted: July 15, 2021
• Study Start: July 15, 2021
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: November 22, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Requests for sharing individual participant data will be considered at the time of publication of the first manuscript containing result data.
• Access Criteria: We plan to share data on request at this point in time.

Locations

DE (1)