NCT07483853

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

Reliability and Validation of the WB-MRI Radiological Score in CRMO: Retrospective Observational Study in Paediatric Patients

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 15 (estimated)
• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna · Academic / Other
• Sex: All
• Age: 32 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study seeks to investigate the reliability and clinical utility of a standardized WB-MRI scoring system for assessing disease activity in Chronic Recurrent Multifocal Osteomyelitis (CRMO), a rare pediatric autoinflammatory bone disorder. Although WB-MRI is the current reference technique for detecting both symptomatic and silent lesions, its interpretation remains highly dependent on the radiologist's experience, leading to variability in follow-up assessment. A structured radiologic score has recently been proposed, but its reproducibility and its relationship with clinical disease activity-measured through the PedCNO composite score-are still insufficiently defined. The primary aim of this work is to determine the inter-observer reliability of the WB-MRI score when independently applied in a blinded manner by experienced pediatric radiologists. In parallel, the study explores how this radiologic score correlates with clinical indicators of disease activity and whether changes in WB-MRI findings over time accurately mirror therapeutic response. By examining the association between variations in the radiologic score and the treatments administered, the study ultimately seeks to clarify the potential role of WB-MRI scoring as an objective, reproducible tool for integrated clinical-radiological management of CRMO.

Conditions

• Chronic Recurrent Multifocal Osteomyelitis
• Pediatrics

Timeline

• Start date: 2027-01-01
• Primary completion: 2027-04-01
• Completion: 2027-07-01
• First posted: 2026-03-19
• Last updated: 2026-03-19

Locations

1 site across 1 country: Italy