Chronic Recurrent Multifocal OsteomyelitisNCT07483853
Reliability and Validation of the WB-MRI Radiological Score in CRMO
An observational study of Chronic Recurrent Multifocal Osteomyelitis and Pediatrics, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 32 years
- Conditions the study is for
- Chronic Recurrent Multifocal Osteomyelitis, Pediatrics
- How many people
- 15 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2027to 1 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 32 years
- All sexes
- No healthy volunteers
- Child, Adult
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
Who may be able to join
- 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.
Who cannot join
- Alternative diagnoses accounting for the bone lesions (e.g., infections, neoplasms).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, 40138
Angela Miniaci, 00390512144811, angela.miniaci@aosp.bo.it
About this study
Official title: Reliability and Validation of the WB-MRI Radiological Score in CRMO: Retrospective Observational Study in Paediatric Patients
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.
Read the 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.
- Medical subject headings
- Chronic recurrent multifocal osteomyelitis
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start1 Jan 2027 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Recurrent Multifocal OsteomyelitisStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angela Miniaci, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07483853
- Sponsor's protocol ID
- RE-WBCRMO
- Status last verified
- Dec 2025
- First submitted
- 11 Mar 2026
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability and Validation of the WB-MRI Radiological Score in CRMO: Retrospective Observational Study in Paediatric Patients
- ClinicalTrials.gov ID
- NCT07483853
- Acronym / sponsor ID
- RE-WBCRMO
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 19 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 32 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- Alternative diagnoses accounting for the bone lesions (e.g., infections, neoplasms).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
To evaluate the clinical-radiological correlation between the WB-MRI radiologic score and the PedCNO clinical score
Time frame: at baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Recurrent Multifocal Osteomyelitis and Pediatrics, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Angela Miniaci (00390512144811, angela.miniaci@aosp.bo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.