Reliability of a whole-body MRI score for CRMO
Official title: Reliability and Validation of the WB-MRI Radiological Score in CRMO: Retrospective Observational Study in Paediatric Patients
Run by IRCCS Azienda Ospedaliero-Universitaria di Bologna · NCT07483853 · Data updated 2026-11-12
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 |
|---|---|
| Ages | Any age to 32 Years |
| Sex | All |
| Enrollment | 15 (estimated) |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 1 site (Bologna) |
| Status | Recruiting |
| Started | January 1, 2027 |
| Main results expected | April 1, 2027 |
| Study ends | July 1, 2027 |
| Registry record updated | March 19, 2026 |
| Trial ID | NCT07483853 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Structured WB-MRI scoring methods for CRMO have been proposed in prior work, but reproducibility and robust correlation with clinical scores remain incompletely validated.
Who can join: the full rules
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 it's running
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IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Italy Recruiting
Study contacts
- Study coordinator: Angela Miniaci
- Email: angela.miniaci@aosp.bo.it
- Phone: 00390512144811
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.