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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 Spondyloarthritis Patients (FNa)

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ClinicalTrials.gov Identifier: NCT02869100
Recruitment Status : Completed
First Posted : August 16, 2016
Last Update Posted : August 16, 2016
Sponsor:
Information provided by (Responsible Party):
Central Hospital, Nancy, France

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.


Condition or disease Intervention/treatment Phase
Spondyloarthritis Other: Blood sample Procedure: Sodium fluoride Positron Emission Tomography Other: Magnetic Resonance Imaging Other: Radiography Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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 Start Date : January 2013
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

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Arm Intervention/treatment
Experimental: Spondyloarthritis Patients Other: Blood sample
Procedure: Sodium fluoride Positron Emission Tomography
Other: Magnetic Resonance Imaging
Other: Radiography



Primary Outcome Measures :
  1. Concordance between binary topographic evaluations of bone inflammation in PET data and MRI data [ Time Frame: up to 4 weeks ]
    presence or absence of inflammatory sites (MRI) or hyperfixation (PET) in 28 sites (24 vertebrae and 4 sacroiliac joints)

  2. Concordance between semi-quantitative evaluation of bone inflammation in MRI data and PET data [ Time Frame: up to 4 weeks ]

    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



Secondary Outcome Measures :
  1. Structural evaluation with New York score [ Time Frame: day 0 ]
  2. Structural evaluation with mSASSS scores [ Time Frame: day 0 ]
  3. Structural evaluation with BASRI score [ Time Frame: day 0 ]
  4. Levels of specific biologic markers of inflammation and bone remodeling in blood [ Time Frame: up to 4 weeks ]
    MMP-3, DKK-1, IL-6, IL-17, TNF-α

  5. Standard biologic evaluation of sedimentation rate [ Time Frame: day 0 ]
  6. Standard biologic evaluation of C-reactive protein [ Time Frame: day 0 ]
  7. Evaluation of spinal mobility with BASMI index [ Time Frame: up to 4 weeks ]
  8. Evaluation of disease activity with BASDAI index [ Time Frame: up to 4 weeks ]
  9. Evaluation of functional impact with BASFI index [ Time Frame: up to 4 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02869100


Locations
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France
CHU de Nancy, Hôpitaux de Brabois
Vandœuvre-lès-Nancy, France
Sponsors and Collaborators
Central Hospital, Nancy, France
Investigators
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Principal Investigator: Pierre OLIVIER, Pr CHU de Nancy, Hôpitaux de Brabois, service de Médecine Nucléaire

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Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT02869100     History of Changes
Other Study ID Numbers: 2012-A00568-35
First Posted: August 16, 2016    Key Record Dates
Last Update Posted: August 16, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Central Hospital, Nancy, France:
magnetic resonance imaging
sodium fluoride positron emission tomography

Additional relevant MeSH terms:
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Sodium Fluoride
Listerine
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Arthritis
Joint Diseases
Fluorides
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents