ClinicalTrials.gov record 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
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This retrospective observational study evaluates a standardized whole‑body MRI (WB‑MRI) radiologic score in people with pediatric-onset CRMO (diagnosed before age 18; some may now be people up to 32 years old). Experienced pediatric radiologists will independently and blinded apply the score to existing WB‑MRI exams and the results will be compared with the PedCNO clinical disease activity score. The study aims to measure how consistently the score is applied and whether changes in the score track with clinical measures and past treatments.
What it is studying. The study tests whether a structured WB‑MRI radiologic scoring system is reproducible when used by different pediatric radiologists, and whether those radiologic scores align with the PedCNO clinical disease activity score and with changes seen over time in patients' records.
What the researchers hope to learn. Determine the inter‑observer reliability of the WB‑MRI radiologic score for CRMO; evaluate the clinical–radiological correlation with the PedCNO score; assess whether changes in the WB‑MRI score reflect recorded therapeutic response and treatment course.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
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).
Study description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Detailed description from the registry
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.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
The study involves review of existing whole-body MRI (WB-MRI) images and past medical records from routine care. At least two experienced pediatric radiologists will independently and blindly apply a standardized WB-MRI score to those images, and clinical information will be used to calculate the PedCNO clinical score for comparison. This is a retrospective review of past tests and notes; the record does not describe any new tests, procedures, or invasive sampling as part of the study. Participation requires providing informed consent for the researchers to access and use your prior images and clinical documentation.
How the study is structured. A retrospective observational cohort study using WB‑MRI exams and clinical records already collected during routine care. At least two experienced pediatric radiologists will independently (and blinded) score each WB‑MRI. The radiologic scores will be compared with PedCNO clinical scores and with documented changes in imaging over time; inter‑observer agreement will be measured.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
- The listed sites are in Italy. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on chronic recurrent multifocal osteomyelitis
Important dates
- Study start
- Jan 1, 2027 (estimated)
- Primary completion
- Apr 1, 2027 (estimated)
- Study completion
- Jul 1, 2027 (estimated)
- Target enrollment
- 15 participants (estimated)
- Last updated on registry
- Mar 19, 2026
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Principal investigator
- Angela Miniaci, MD
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Angela Miniaci 📞 00390512144811 ✉ angela.miniaci@aosp.bo.it
Participating sites (1)
- IRCCS Azienda Ospedaliero-Universitaria di BolognaRecruiting
Bologna, 40138 · Italy
- Angela Miniaci · 00390512144811 · angela.miniaci@aosp.bo.it
Terms used on this page · explanations by MedicalUpdates.ai
- MRI
- A scan that uses magnets and radio waves, not X-rays, to make detailed pictures of the inside of the body. Some implants and metal objects mean a person cannot have one.
- follow-up
- The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
- informed consent
- The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
- blinded
- Who does not know which intervention a participant is receiving. It can apply to participants, the people giving the treatment, those assessing results, or those analysing the data.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
← Back to clinical trials