Characterization of mechanical and inflammatory bone marrow edema of the sacroiliac joints using quantitative MR imaging and perfusion CT

Phase 1

• Conditions: M45.0

• Registration Number: DRKS00033725
• Lead Sponsor: Klinik für Radiologie, Charité - Universitätsmedizin Berlin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-05
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 128

Inclusion Criteria

Phase 1:
• Postpartum women within 10 days of natural birth
• Age > 18 years
• Written declaration of consent
Healthy control:
• Age > 18 years
• Written declaration of consent
• Female gender
• Existing health insurance so that in the event of incidental findings, these can be clarified

Phase 2:
• Known sacroiliitis associated with axial spondyloarthritis OR mechanical disease of the SIJ
• Age > 18 years
• Written declaration of consent

Exclusion Criteria

Phase 1:
• Known or suspected rheumatological diseases
• Deep-seated back pain
• Recent delivery
• Pacemakers or other metal implants with limited MR compatibility
• Severe claustrophobia
• Pregnancy
• Persons incapable of consent and minors
• Sensorineural hearing loss of 30 dB or more or tinnitus

Phase 2:
• Pacemakers or other metal implants with limited MR compatibility
• Severe claustrophobia
• Known intolerance to iodine-based contrast media
• Renal insufficiency (GFR < 30 ml/min)
• Manifest hyperthyroidism
• Pregnancy
• Persons incapable of consent and minors

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean signal intensities measured in % signal increase on diffusion-weighted sequences as well as T1 and T2 mapping sequences (three primary endpoints) differ significantly between inflammatory and mechanical bone marrow edema.

Secondary Outcome Measures

Name	Time	Method
• MR spectroscopic metabolite spectra differ between bone marrow edema and healthy bone tissue and between inflammatory and mechanical bone marrow edema.<br>• The MR tomographic perfusion pattern of mechanical and inflammatory bone marrow changes differs significantly.<br>• Using contrast-enhanced CT, bone marrow edema can be visualized on CT just as well as on MRI.<br>• Quantitative parameters of CT perfusion correlate with those of MRI perfusion.<br>• Texture analysis parameters (radiomics) can differentiate between inflammatory and mechanical bone marrow edema.