Comparison of Sodium Fluoride Positron Emission Tomography and Magnetic Resonance Imaging of Spine and Sacroiliac Joints for Detection of Inflammatory Lesions in Spondyloarthritis Patients

Study Overview
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Brief Summary
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The purpose is to compare detection of axial inflammatory lesions in patients affected by spondyloarthritis (SpA) with sodium fluoride positron emission tomography (PET) and magnetic resonance imaging (MRI), the reference technique. It would be interesting to show the superiority of sodium fluoride PET on MRI for diagnosis of inflammatory lesions. It could be used for diagnostic care but also therapeutic care of patients with early forms of spondyloarthritis. Secondary purposes are: To evaluate performances of sodium fluoride PET in detection of SpA peripheral damage (except spine and sacroiliac joints) To evaluate bone inflammation (axial and peripheral) with sodium fluoride PET and compare these data to clinic-biologic parameters used in clinical practice (BASDAI, BASFI, BASMI, sedimentation rate, C-reactive protein (CRP)) and to structural evaluation (sacroiliac New York, mSASSS and BASRI scoring methods) To study correlation of axial and peripheral bone inflammation (spine and sacroiliac joints) evaluated with sodium fluoride PET with biologic markers of inflammation and bone remodeling (MMP-3; DKK-1, IL-6, IL-17, TNF-α). Known biologic markers of inflammation in SpA are correlated to activity obtained with MRI. It is interesting to compare to activity obtained with PET. Moreover, it has been recently showed the disassociation of inflammation and structural progression (anti-TNF treatments do not prevent structural progression) that is associated to markers of bone remodeling whose activity is influenced by an activation/inhibition system of biologic markers of inflammation.

Official Title
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Comparison of Sodium Fluoride Positron Emission Tomography and Magnetic Resonance Imaging of Spine and Sacroiliac Joints for Detection of Inflammatory Lesions in Patients Affected by Spondyloarthritis

Conditions
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Spondyloarthritis

Intervention / Treatment
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* Other: Blood sample
* Procedure: Sodium fluoride Positron Emission Tomography
* Other: Magnetic Resonance Imaging
* Other: Radiography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-50 year-old patients affected by axial or mixed SpA (ASAS criteria) or >18 year-old patients according to New York criteria Patients with bone marrow edema lesions in sacroiliac joints and/or spine detected with MRI No therapeutic changes between hospitalization for evaluation of SpA activity and inclusion visit Informed consent Affiliation to social security plan Exclusion Criteria: Refusal or impossibility of signed informed consent Doubt about possible pregnancy in women of childbearing potential Pregnancy and breastfeeding History of drug addiction, alcoholism, psychological problems, severe co-morbidities Renal insufficiency (creatinine clearance < 60 ml/min) Juridical protection

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spondyloarthritis Patients<br> | Other: Blood sample<br> <br> Procedure: Sodium fluoride Positron Emission Tomography<br> <br> Other: Magnetic Resonance Imaging<br> <br> Other: Radiography<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concordance between binary topographic evaluations of bone inflammation in PET data and MRI data | presence or absence of inflammatory sites (MRI) or hyperfixation (PET) in 28 sites (24 vertebrae and 4 sacroiliac joints) | up to 4 weeks | 
| Concordance between semi-quantitative evaluation of bone inflammation in MRI data and PET data | PET: BME score adapted to PET for spine and modified SPARCC score adapted to PET for sacroiliac joints MRI: Berlin score BME for spine and SPARCC score for sacroiliac joints | up to 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Structural evaluation with New York score |  | day 0 | 
| Structural evaluation with mSASSS scores |  | day 0 | 
| Structural evaluation with BASRI score |  | day 0 | 
| Levels of specific biologic markers of inflammation and bone remodeling in blood | MMP-3, DKK-1, IL-6, IL-17, TNF-α | up to 4 weeks | 
| Standard biologic evaluation of sedimentation rate |  | day 0 | 
| Standard biologic evaluation of C-reactive protein |  | day 0 | 
| Evaluation of spinal mobility with BASMI index |  | up to 4 weeks | 
| Evaluation of disease activity with BASDAI index |  | up to 4 weeks | 
| Evaluation of functional impact with BASFI index |  | up to 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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magnetic resonance imaging, sodium fluoride positron emission tomography