Skip to main content
OpenTrials
Completed

NCT Number: 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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Nancy, Hôpitaux de Brabois

Vandœuvre-lès-Nancy, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

blood sample

Other

Sodium fluoride Positron Emission Tomography

Procedure

Magnetic Resonance Imaging

Other

Radiography

Other

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study 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

Acronym: FNa

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Aug 16, 2016
Registry last updated
Aug 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.