Comparison of Sodium Fluoride Positron Emission Tomography and Magnetic Resonance Imaging of Spine and Sacroiliac Joints for Detection of Inflammatory Lesions in Spondyloarthritis Patients
NCT ID: NCT02869100
Last Updated: 2016-08-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
26 participants
INTERVENTIONAL
2013-01-31
2015-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Spondyloarthritis Patients
Blood sample
Sodium fluoride Positron Emission Tomography
Magnetic Resonance Imaging
Radiography
Interventions
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Blood sample
Sodium fluoride Positron Emission Tomography
Magnetic Resonance Imaging
Radiography
Eligibility Criteria
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Inclusion 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
* 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
18 Years
ALL
No
Sponsors
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Central Hospital, Nancy, France
OTHER
Responsible Party
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Principal Investigators
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Pierre OLIVIER, Pr
Role: PRINCIPAL_INVESTIGATOR
CHU de Nancy, Hôpitaux de Brabois, service de Médecine Nucléaire
Locations
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CHU de Nancy, Hôpitaux de Brabois
Vandœuvre-lès-Nancy, , France
Countries
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Other Identifiers
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2012-A00568-35
Identifier Type: -
Identifier Source: org_study_id
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