Clinical trial NCT02869100: Comparison of Sodium Fluoride Positron Emission Tomography and Magnetic Resonance Imaging of Spine and Sacroiliac Joints for Detection of Inflammatory Lesions in Spondyloarthritis Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spondyloarthritis
Keywords: magnetic resonance imaging
sodium fluoride positron emission tomography
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2016-08-16
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Concordance between binary topographic evaluations of bone inflammation in PET data and MRI data
timeFrame: up to 4 weeks
measure: Concordance between semi-quantitative evaluation of bone inflammation in MRI data and PET data
timeFrame: up to 4 weeks
Secondary outcomes:
measure: Structural evaluation with New York score
timeFrame: day 0
measure: Structural evaluation with mSASSS scores
timeFrame: day 0
measure: Structural evaluation with BASRI score
timeFrame: day 0
measure: Levels of specific biologic markers of inflammation and bone remodeling in blood
timeFrame: up to 4 weeks
measure: Standard biologic evaluation of sedimentation rate
timeFrame: day 0
measure: Standard biologic evaluation of C-reactive protein
timeFrame: day 0
measure: Evaluation of spinal mobility with BASMI index
timeFrame: up to 4 weeks
measure: Evaluation of disease activity with BASDAI index
timeFrame: up to 4 weeks
measure: Evaluation of functional impact with BASFI index
timeFrame: up to 4 weeks
Other outcomes:
Locations:
city: Vandœuvre-lès-Nancy
country: France
facility: CHU de Nancy, Hôpitaux de Brabois
Study officials:
affiliation: CHU de Nancy, Hôpitaux de Brabois, service de Médecine Nucléaire
name: Pierre OLIVIER, Pr
role: PRINCIPAL_INVESTIGATOR
References: