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NCT Number: NCT07483853

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

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.

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Key information

Age range

Up to 32 year

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

Location status: Recruiting

Location contact

Angela Miniaci

CONTACT

[email protected]

00390512144811

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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

    Time frame: at baseline

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

Secondary outcomes

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

    Time frame: at baseline

    WB-MRI score AND PedCNO score

Study contacts

Contact information is provided by the study sponsor or research team.

Angela Miniaci

CONTACT

[email protected]

00390512144811

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Official study title

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

Important dates

Study start
2027
Primary completion
2027
Study completion
2027
First posted
Mar 19, 2026
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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