Chronic Recurrent Multifocal OsteomyelitisNCT03433287
Chronic Recurrent Multifocal Osteomyelitis - a Bacterial Cause?
A study testing 18F-NaF-PET/MRI in people with Chronic Recurrent Multifocal Osteomyelitis, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
Chronic recurrent multifocal osteomyelitis (CRMO) is an immune-mediated chronic inflammatory self- limiting disease with non-suppurative inflammation involving one or multiple bone foci. A bacterial etiology has not yet been proven, but the investigators hypothesize that CRMO is caused by chronic infection. Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Chronic Recurrent Multifocal Osteomyelitis
- What is being tested?
- 18F-NaF-PET/MRI
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Nov 2015to 1 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 0 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- CRMO diagnosis verified by biopsy
- Age under 18 years at diagnosis
- Malignant disease excluded
- Informed written consent
Who cannot join
- Bone biopsy not performed
- Patients not eligible for MRI (metallic foreign objects, severe claustrophobia)
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Chronic Recurrent Multifocal Osteomyelitis - Search for a Bacterial Cause and Improving Imaging With PET/MRI
Chronic recurrent multifocal osteomyelitis (CRMO) is an immune-mediated chronic inflammatory self- limiting disease with non-suppurative inflammation involving one or multiple bone foci. A bacterial etiology has not yet been proven, but the investigators hypothesize that CRMO is caused by chronic infection. Using existing knowledge of chronic infections combined with sensitive molecular techniques, the hope is to elucidate the cause of CRMO by proving or disproving bacteria as the underlying etiology.
In addition, a novel method, 18F-NaF-PET/MRI, will be investigated as to which it can improve diagnosis of CRMO. The investigators hypothesize that 18F-NaF-PET/MRI will have higher diagnostic accuracy than 99m-diphosphonate planar bone scintigraphy and SPECT/CT.
Read the detailed description
Epidemiology, clinical manifestations and prognosis Chronic recurrent multifocal osteomyelitis (CRMO) is an immune-mediated chronic inflammatory self- limiting disease with non-suppurative inflammation involving one or multiple bone foci. The disease occurs primarily in children and adolescents. The estimated prevalence is 1-5/10.000 in the European population, but since there are no studies providing precise estimates, the number of cases can be both under- and overestimated.
The mean age of CRMO onset is 10 years. There is a female preponderance with twice as many girls affected.
CRMO presents with bone pain with or without swelling and warmth. Some patients have a more acute presentation with severe pain, malaise and fever. All bones except the neurocranium can be affected. Involvement of the clavicle is classical, but the metaphyses of the long bones, the mandible and the pelvis are also frequently affected. Vertebral involvement is seen in 4 to 30% of cases in retrospective studies.
Extra-skeletal involvement can include the skin, the eyes and the gastrointestinal tract. Involvement of the skin may manifest as plantar pustulosis, psoriasis acne, pyoderma gangrenosum and Sweet Syndrome. In the gastrointestinal tract, Crohn's disease or lesions mimicking this disease have been associated with CRMO.
Previously, the prognosis of CRMO patients was considered favorable, as the disease is often self-limiting, but newer studies have revealed that physical impairment may persist in up to 50% of patients. They typically suffer from chronic pain, bone deformities and have increased fracture risk. Furthermore, there is evidence that CRMO may evolve into spondyloarthropathy with clinical and radiological sacroiliitis.
Pathophysiology The pathophysiology of CRMO is largely unknown, but is regarded as an auto-inflammatory bone disorder. Recent findings indicate that an imbalance between the pro-inflammatory cytokines Interleukine-6 (IL-6) and Tumor Necrosis Factor α (TNF-α), and the anti-inflammatory cytokine IL-10 may play a central role in the molecular pathology of CRMO. High levels of IL-6 and TNF-α have been found in serum from CRMO patients. Furthermore, it has been demonstrated that monocytes in patients with CRMO fail to produce IL-10. IL-10 is an immunomodulatory cytokine that attenuates inflammation on multiple levels.
However, in bone biopsies from CRMO patients, the lesions resemble infectious osteomyelitis histologically. Initially the predominating cell types are neutrophils, but in later disease stages monocytes, macrophages, lymphocytes and plasma cells can be detected. In the final disease stage of CRMO sclerosis and/or fibrosis can be seen. Infection with propionibacterium acnes (P. acnes) or other commensal skin bacteria (i.e. Bartonella) have been suggested to trigger CRMO. P. acnes may induce the toll-like receptors in the monocyte cell membrane, resulting in mitogen-activated protein kinase (MAP kinase) activation leading to production of pro-inflammatory cytokines. This could suggest that bacteria might be the reason for the observed imbalance in the pro-inflammatory cytokines, but the presence of bacteria in biopsies from CRMO lesions has only been demonstrated in single cases. However, in the majority of reported cases the microbiological investigations were performed solely by the use of microbiological culture and very few studies have utilized modern molecular techniques. The methods applied in these studies are more than 10 years old and the microbiological investigations are far more advanced today.
Discrepancy between bacteria found by culture swaps and modern molecular techniques have been seen in chronic wounds and chronic infection in soft tissue fillers lesions. In these chronic infections the bacteria are able to form a biofilm. The biofilm itself induces an ongoing inflammatory reaction, as it provides a protected environment for the bacteria, in which they may avoid the effects of antibiotics and host immune defence. Bacteria in biofilm grow in small clusters like planktonic bacterial cells and this complicates identification of these microorganisms in biopsy material.
Furthermore, a porcine model demonstrated chronic inflammation with formation of biofilm in bone infected with Staphylococcus aureus. S. aureus is the most frequent cause of osteomyelitis in children.
Diagnosis There are no validated diagnostic criteria and no diagnostic tests for CRMO. First of all, it is important to exclude differential diagnoses as infection (mycobacterium, septic osteomyelitis etc.), malignancies (bone tumors, metastases, leukemia or lymphoma), benign tumors (osteoid osteoma, bone cysts, fibrosis etc.) or other auto-inflammatory disorders. Biopsy is often needs to exclude an infections etiology or malignancy.
Bone scintigraphy using methylene diphosphonate or hydroxymethylene diphosphonate labeled with Technetium 99m has high sensitivity in identifying symptomatic as well as asymptomatic lesions. Monitoring disease activity during treatment or follow-up is also possible with bone scintigraphy by evaluating the degree of tracer uptake in the lesions. Furthermore, the technique can be useful in targeting biopsy to the most active lesion or identifying a more easily accessible lesion than the presenting site.
Another frequently used modality to diagnose CRMO is whole-body Magnetic Resonance Imaging (MRI). A study comparing MRI and planar bone scintigraphy found higher sensitivity of MRI in identifying CRMO lesions. Especially lesions in the spine, pelvis and femora were better visualized by MRI.
The functional imaging of bone scintigraphy and the morphological information from MRI can be combined in Positron Emission tomography (PET)/MRI. PET/MRI using 18F-fluorodeoxy-glucose (18FDG) is increasingly used clinically and in research settings in pediatric patients with malignant disease. The PET-tracer fluoride 18-labeled sodium fluoride (18F-NaF) is a positron-emitting bone-seeking tracer that provides higher resolution and better signal-to-background images, compared to 99mTc-diphosphonate bone tracers. Studies of 18F-NaF-PET in pediatric patients conclude the technique is useful for investigating the cause of bone pain in children.
There are several potential advantages of 18F-NaF-PET/ MRI. Simultaneous acquisition of PET and MRI reduces the use of anesthesia and sedation, which is often required for younger children. The effective radiation dose of 18F-NaF-PET is approximately 3 milliSievert (mSv), which corresponds to the dose from a 99mTc-diphosphonate bone scintigraphy. Whole body MRI eliminates the need for low-dose CT scan used in SPECT and therefore reduces total radiation dose to the child.
The added value of 18F-NaF-PET/MRI in CRMO patients has not yet been investigated. The hypothesis is that the technique has the potential of being a novel gold-standard method for evaluating bone pathology in children, with the superior morphological images from MRI and high resolution imaging of bone metabolism from 18F-NaF-PET.
- Being tested
- 18F-NaF-PET/MRI
- Medical subject headings
- Chronic recurrent multifocal osteomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-NaF-PET/MRIDiagnostic test
PET/MRI scan after injection of 18F-labelled sodium fluoride
| Study group | Role | What they receive |
|---|---|---|
| 18F-NaF-PET/MRI | Experimental | Eligible patients who give informed consent will be offered a NaF -PET/MRI scan Receives: Diagnostic Test: 18F-NaF-PET/MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of detected CRMO lesions
Compare no. of detected CRMO lesions on PET/MRI and standard diagnostic tests
Measured: 1 hour after PET/MRI scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2018
- Study start1 Nov 2015
- Primary completion1 Jan 2022
- Study completion1 Dec 2022 (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 Copenhagen University Hospital, RigshospitaletThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open cohort study
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Sjælland
- Responsible party
- Principal investigator, Marie Øbro Fosbøl, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Lise Borgwardt, PhD, Principal investigator, Rigshospitalet, Department of Clinical Physiology, Nuclear Medicine & PET
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03433287
- Sponsor's protocol ID
- Protokol-49657
- Status last verified
- May 2022
- First submitted
- 8 Feb 2018
- Last updated
- 24 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Recurrent Multifocal Osteomyelitis - Search for a Bacterial Cause and Improving Imaging With PET/MRI
- ClinicalTrials.gov ID
- NCT03433287
- Acronym / sponsor ID
- Protokol-49657
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Region Sjælland
- Study start
- 1 Nov 2015 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 14 Feb 2018 (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.
Chronic recurrent multifocal osteomyelitis (CRMO) is an immune-mediated chronic inflammatory self- limiting disease with non-suppurative inflammation involving one or multiple bone foci. A bacterial etiology has not yet been proven, but the investigators hypothesize that CRMO is caused by chronic infection. Using existing knowledge of chronic infections combined with sensitive molecular techniques, the hope is to elucidate the cause of CRMO by proving or disproving bacteria as the underlying etiology.
In addition, a novel method, 18F-NaF-PET/MRI, will be investigated as to which it can improve diagnosis of CRMO. The investigators hypothesize that 18F-NaF-PET/MRI will have higher diagnostic accuracy than 99m-diphosphonate planar bone scintigraphy and SPECT/CT.
Detailed description
Epidemiology, clinical manifestations and prognosis Chronic recurrent multifocal osteomyelitis (CRMO) is an immune-mediated chronic inflammatory self- limiting disease with non-suppurative inflammation involving one or multiple bone foci. The disease occurs primarily in children and adolescents. The estimated prevalence is 1-5/10.000 in the European population, but since there are no studies providing precise estimates, the number of cases can be both under- and overestimated.
The mean age of CRMO onset is 10 years. There is a female preponderance with twice as many girls affected.
CRMO presents with bone pain with or without swelling and warmth. Some patients have a more acute presentation with severe pain, malaise and fever. All bones except the neurocranium can be affected. Involvement of the clavicle is classical, but the metaphyses of the long bones, the mandible and the pelvis are also frequently affected. Vertebral involvement is seen in 4 to 30% of cases in retrospective studies.
Extra-skeletal involvement can include the skin, the eyes and the gastrointestinal tract. Involvement of the skin may manifest as plantar pustulosis, psoriasis acne, pyoderma gangrenosum and Sweet Syndrome. In the gastrointestinal tract, Crohn's disease or lesions mimicking this disease have been associated with CRMO.
Previously, the prognosis of CRMO patients was considered favorable, as the disease is often self-limiting, but newer studies have revealed that physical impairment may persist in up to 50% of patients. They typically suffer from chronic pain, bone deformities and have increased fracture risk. Furthermore, there is evidence that CRMO may evolve into spondyloarthropathy with clinical and radiological sacroiliitis.
Pathophysiology The pathophysiology of CRMO is largely unknown, but is regarded as an auto-inflammatory bone disorder. Recent findings indicate that an imbalance between the pro-inflammatory cytokines Interleukine-6 (IL-6) and Tumor Necrosis Factor α (TNF-α), and the anti-inflammatory cytokine IL-10 may play a central role in the molecular pathology of CRMO. High levels of IL-6 and TNF-α have been found in serum from CRMO patients. Furthermore, it has been demonstrated that monocytes in patients with CRMO fail to produce IL-10. IL-10 is an immunomodulatory cytokine that attenuates inflammation on multiple levels.
However, in bone biopsies from CRMO patients, the lesions resemble infectious osteomyelitis histologically. Initially the predominating cell types are neutrophils, but in later disease stages monocytes, macrophages, lymphocytes and plasma cells can be detected. In the final disease stage of CRMO sclerosis and/or fibrosis can be seen. Infection with propionibacterium acnes (P. acnes) or other commensal skin bacteria (i.e. Bartonella) have been suggested to trigger CRMO. P. acnes may induce the toll-like receptors in the monocyte cell membrane, resulting in mitogen-activated protein kinase (MAP kinase) activation leading to production of pro-inflammatory cytokines. This could suggest that bacteria might be the reason for the observed imbalance in the pro-inflammatory cytokines, but the presence of bacteria in biopsies from CRMO lesions has only been demonstrated in single cases. However, in the majority of reported cases the microbiological investigations were performed solely by the use of microbiological culture and very few studies have utilized modern molecular techniques. The methods applied in these studies are more than 10 years old and the microbiological investigations are far more advanced today.
Discrepancy between bacteria found by culture swaps and modern molecular techniques have been seen in chronic wounds and chronic infection in soft tissue fillers lesions. In these chronic infections the bacteria are able to form a biofilm. The biofilm itself induces an ongoing inflammatory reaction, as it provides a protected environment for the bacteria, in which they may avoid the effects of antibiotics and host immune defence. Bacteria in biofilm grow in small clusters like planktonic bacterial cells and this complicates identification of these microorganisms in biopsy material.
Furthermore, a porcine model demonstrated chronic inflammation with formation of biofilm in bone infected with Staphylococcus aureus. S. aureus is the most frequent cause of osteomyelitis in children.
Diagnosis There are no validated diagnostic criteria and no diagnostic tests for CRMO. First of all, it is important to exclude differential diagnoses as infection (mycobacterium, septic osteomyelitis etc.), malignancies (bone tumors, metastases, leukemia or lymphoma), benign tumors (osteoid osteoma, bone cysts, fibrosis etc.) or other auto-inflammatory disorders. Biopsy is often needs to exclude an infections etiology or malignancy.
Bone scintigraphy using methylene diphosphonate or hydroxymethylene diphosphonate labeled with Technetium 99m has high sensitivity in identifying symptomatic as well as asymptomatic lesions. Monitoring disease activity during treatment or follow-up is also possible with bone scintigraphy by evaluating the degree of tracer uptake in the lesions. Furthermore, the technique can be useful in targeting biopsy to the most active lesion or identifying a more easily accessible lesion than the presenting site.
Another frequently used modality to diagnose CRMO is whole-body Magnetic Resonance Imaging (MRI). A study comparing MRI and planar bone scintigraphy found higher sensitivity of MRI in identifying CRMO lesions. Especially lesions in the spine, pelvis and femora were better visualized by MRI.
The functional imaging of bone scintigraphy and the morphological information from MRI can be combined in Positron Emission tomography (PET)/MRI. PET/MRI using 18F-fluorodeoxy-glucose (18FDG) is increasingly used clinically and in research settings in pediatric patients with malignant disease. The PET-tracer fluoride 18-labeled sodium fluoride (18F-NaF) is a positron-emitting bone-seeking tracer that provides higher resolution and better signal-to-background images, compared to 99mTc-diphosphonate bone tracers. Studies of 18F-NaF-PET in pediatric patients conclude the technique is useful for investigating the cause of bone pain in children.
There are several potential advantages of 18F-NaF-PET/ MRI. Simultaneous acquisition of PET and MRI reduces the use of anesthesia and sedation, which is often required for younger children. The effective radiation dose of 18F-NaF-PET is approximately 3 milliSievert (mSv), which corresponds to the dose from a 99mTc-diphosphonate bone scintigraphy. Whole body MRI eliminates the need for low-dose CT scan used in SPECT and therefore reduces total radiation dose to the child.
The added value of 18F-NaF-PET/MRI in CRMO patients has not yet been investigated. The hypothesis is that the technique has the potential of being a novel gold-standard method for evaluating bone pathology in children, with the superior morphological images from MRI and high resolution imaging of bone metabolism from 18F-NaF-PET.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open cohort study
| Arm | Type | Receives |
|---|---|---|
| 18F-NaF-PET/MRI | Experimental | Diagnostic Test: 18F-NaF-PET/MRIEligible patients who give informed consent will be offered a NaF -PET/MRI scan |
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- CRMO diagnosis verified by biopsy
- Age under 18 years at diagnosis
- Malignant disease excluded
- Informed written consent
Key exclusion criteria (3 listed)
- Bone biopsy not performed
- Patients not eligible for MRI (metallic foreign objects, severe claustrophobia)
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-NaF-PET/MRIPET/MRI scan after injection of 18F-labelled sodium fluoride | Diagnostic test | 18F-NaF-PET/MRI |
Primary outcome
Number of detected CRMO lesions
Time frame: 1 hour after PET/MRI scan
Compare no. of detected CRMO lesions on PET/MRI and standard diagnostic tests
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2022.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Lise Borgwardt, PhD principal investigator
Rigshospitalet, Department of Clinical Physiology, Nuclear Medicine & PET
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 18F-NaF-PET/MRI in people with Chronic Recurrent Multifocal Osteomyelitis, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 24 May 2022. 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 Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of detected CRMO lesions (time frame: 1 hour after PET/MRI scan). 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 24 May 2022.