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

NCT02869100 | Completed

• 1 other identifier: 2012-A00568-35
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Spondyloarthritis

Keywords

magnetic resonance imaging; sodium fluoride positron emission tomography

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• 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

  up to 4 weeks

• Standard biologic evaluation of sedimentation rate

  day 0

Study Arms (1)

Spondyloarthritis Patients

EXPERIMENTAL

Other: Blood sample; Procedure: Sodium fluoride Positron Emission Tomography; Other: Magnetic Resonance Imaging; Other: Radiography

Interventions

Blood sample OTHER

Spondyloarthritis Patients

Sodium fluoride Positron Emission Tomography PROCEDURE

Spondyloarthritis Patients

Magnetic Resonance Imaging OTHER

Spondyloarthritis Patients

Radiography OTHER

Spondyloarthritis Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Informed consent
• Affiliation to social security plan

You may not qualify if:

• 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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

CHU de Nancy, Hôpitaux de Brabois

Vandœuvre-lès-Nancy, France

Location

MeSH Terms

Conditions

Spondylarthritis

Interventions

Blood Specimen Collection; Magnetic Resonance Spectroscopy; X-Rays

Condition Hierarchy (Ancestors)

Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Spectrum Analysis; Chemistry Techniques, Analytical; Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Study Officials

• Pierre OLIVIER, Pr

  CHU de Nancy, Hôpitaux de Brabois, service de Médecine Nucléaire

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2016
• First Posted: August 16, 2016
• Study Start: January 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: August 16, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)