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

Spondyloarthritis Clinical Trial

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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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02869100
• Other study ID #: 2012-A00568-35
• Status: Completed
• Phase: N/A
• First received: August 9, 2016
• Last updated: August 11, 2016
• Start date: January 2013
• Est. completion date: March 2015

Study information

• Verified date: August 2016
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Spondylarthritis
• Spondyloarthritis

Intervention

Other:
• Blood sample

Procedure:
• Sodium fluoride Positron Emission Tomography

Other:
• Magnetic Resonance Imaging

• Radiography

Locations

Country	Name	City	State
France	CHU de Nancy, Hôpitaux de Brabois	Vandœuvre-lès-Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	Structural evaluation with New York score		day 0	No
Secondary	Structural evaluation with mSASSS scores		day 0	No
Secondary	Structural evaluation with BASRI score		day 0	No
Secondary	Levels of specific biologic markers of inflammation and bone remodeling in blood	MMP-3, DKK-1, IL-6, IL-17, TNF-a	up to 4 weeks	No
Secondary	Standard biologic evaluation of sedimentation rate		day 0	No
Secondary	Standard biologic evaluation of C-reactive protein		day 0	No
Secondary	Evaluation of spinal mobility with BASMI index		up to 4 weeks	No
Secondary	Evaluation of disease activity with BASDAI index		up to 4 weeks	No
Secondary	Evaluation of functional impact with BASFI index		up to 4 weeks	No