Reliability of a whole-body MRI score for CRMO
Reliability and Validation of the WB-MRI Radiological Score in CRMO: Retrospective Observational Study in Paediatric Patients
This study will test whether a standardized whole-body MRI score reliably reflects disease activity and treatment response in children with CRMO.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 15 (estimated) |
| Ages | N/A to 32 Years |
| Sex | All |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 1 site (Bologna) |
| Trial ID | NCT07483853 on ClinicalTrials.gov |
What this trial studies
This observational study examines the inter-observer reliability of a structured whole-body MRI (WB-MRI) scoring system for Chronic Recurrent Multifocal Osteomyelitis (CRMO) by having experienced pediatric radiologists independently score imaging in a blinded fashion. Investigators will compare those radiologic scores with the PedCNO clinical composite score using retrospective WB-MRI and clinical data collected from children diagnosed before age 18 and followed at the Pediatric Unit of IRCCS AOU Bologna. The study will also analyze changes in the radiologic score over time and correlate those changes with treatments received to see if imaging changes mirror therapeutic response. The goal is to determine whether the WB-MRI score is reproducible and clinically useful as an objective complement to clinical evaluation in CRMO.
Who should consider this trial
Good fit: Ideal candidates are children diagnosed with CRMO by Bristol criteria, under age 18 at diagnosis, who have at least one WB-MRI and complete clinical documentation available at IRCCS AOU Bologna.
Not a fit: Patients who lack WB-MRI images or complete records, who are managed outside the enrolling center, who are adults, or who have alternative diagnoses such as infection or neoplasm are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If validated, the WB-MRI score could give clinicians a reproducible imaging measure to better track disease activity and guide treatment decisions in children with CRMO.
How similar studies have performed: Structured WB-MRI scoring methods for CRMO have been proposed in prior work, but reproducibility and robust correlation with clinical scores remain incompletely validated.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with a diagnosis of CRMO according to the international Bristol clinical and radiologic criteria, followed at the Pediatric Rheumatology Clinic of the Pediatric Unit, IRCCS AOU Bologna, Sant'Orsola Hospital; * Age under 18 years at the time of CRMO diagnosis; * At least one WB-MRI performed as part of routine clinical follow-up between January 2015 and the start date of the study; * Availability of complete clinical documentation (including reports, radiologic images, and clinical information) sufficient to apply both the WB-MRI score and the PedCNO score; * Obtain informed consent. Exclusion Criteria: \- Alternative diagnoses accounting for the bone lesions (e.g., infections, neoplasms).
Where this trial is running
Bologna
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna, Italy (Recruiting)
Study contacts
- Study coordinator: Angela Miniaci
- Email: angela.miniaci@aosp.bo.it
- Phone: 00390512144811
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.