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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 32
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

None

Trial 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

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

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

Time frame
at baseline

Secondary outcomes

1

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

WB-MRI score AND PedCNO score

Time frame
at baseline

Other outcomes

Sponsors and contacts

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