Reliability and Validation of the WB-MRI Radiological Score in CRMO

NCT07483853 | Recruiting

• 1 other identifier: RE-WBCRMO
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the inter-observer reliability of a standardized WB-MRI scoring system for CRMO and its consistency with the PedCNO clinical score. It also investigates whether changes in the radiologic score mirror therapeutic response, supporting a more objective clinical-radiological disease assessment.

Conditions

Chronic Recurrent Multifocal Osteomyelitis; Pediatrics

Outcome Measures

Primary Outcomes (1)

• To assess the inter-observer reliability and reproducibility of the WB-MRI radiologic scoring system for CRMO lesions, applied independently and in a blinded manner by at least two pediatric radiologists for each WB-MRI performed in patients in with CRMO

  Inter-observer agreement for each individual examination, calculated using ICC

  at baseline

Secondary Outcomes (1)

• To evaluate the clinical-radiological correlation between the WB-MRI radiologic score and the PedCNO clinical score

  at baseline

Eligibility Criteria

• Age: Up to 32 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a diagnosis of pediatric-onset CRMO and at least one WB-MRI performed between January 2015 and the start date of the study, followed at the Pediatric Rheumatology Clinic of the Pediatric Unit, IRCCS AOU Bologna, Sant'Orsola Hospital

You may qualify if:

• 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.

You may not qualify if:

• \- Alternative diagnoses accounting for the bone lesions (e.g., infections, neoplasms).

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

RECRUITING

MeSH Terms

Conditions

Chronic recurrent multifocal osteomyelitis

Central Study Contacts

Angela Miniaci

CONTACT

00390512144811; angela.miniaci@aosp.bo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 11, 2026
• First Posted: March 19, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: March 19, 2026

Record last verified: 2025-12

Locations

IT (1)