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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)

Primary Purpose

Spondyloarthritis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood sample
Sodium fluoride Positron Emission Tomography
Magnetic Resonance Imaging
Radiography
Sponsored by
Central Hospital, Nancy, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Spondyloarthritis focused on measuring magnetic resonance imaging, sodium fluoride positron emission tomography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de Nancy, Hôpitaux de Brabois

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Spondyloarthritis Patients

Arm Description

Outcomes

Primary Outcome Measures

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)
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

Secondary Outcome Measures

Structural evaluation with New York score
Structural evaluation with mSASSS scores
Structural evaluation with BASRI score
Levels of specific biologic markers of inflammation and bone remodeling in blood
MMP-3, DKK-1, IL-6, IL-17, TNF-α
Standard biologic evaluation of sedimentation rate
Standard biologic evaluation of C-reactive protein
Evaluation of spinal mobility with BASMI index
Evaluation of disease activity with BASDAI index
Evaluation of functional impact with BASFI index

Full Information

First Posted
August 9, 2016
Last Updated
August 11, 2016
Sponsor
Central Hospital, Nancy, France
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1. Study Identification

Unique Protocol Identification Number
NCT02869100
Brief Title
Comparison of Sodium Fluoride Positron Emission Tomography and Magnetic Resonance Imaging of Spine and Sacroiliac Joints for Detection of Inflammatory Lesions in Spondyloarthritis Patients
Acronym
FNa
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

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Central Hospital, Nancy, France

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spondyloarthritis
Keywords
magnetic resonance imaging, sodium fluoride positron emission tomography

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Spondyloarthritis Patients
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Blood sample
Intervention Type
Procedure
Intervention Name(s)
Sodium fluoride Positron Emission Tomography
Intervention Type
Other
Intervention Name(s)
Magnetic Resonance Imaging
Intervention Type
Other
Intervention Name(s)
Radiography
Primary Outcome Measure Information:
Title
Concordance between binary topographic evaluations of bone inflammation in PET data and MRI data
Description
presence or absence of inflammatory sites (MRI) or hyperfixation (PET) in 28 sites (24 vertebrae and 4 sacroiliac joints)
Time Frame
up to 4 weeks
Title
Concordance between semi-quantitative evaluation of bone inflammation in MRI data and PET data
Description
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
Time Frame
up to 4 weeks
Secondary Outcome Measure Information:
Title
Structural evaluation with New York score
Time Frame
day 0
Title
Structural evaluation with mSASSS scores
Time Frame
day 0
Title
Structural evaluation with BASRI score
Time Frame
day 0
Title
Levels of specific biologic markers of inflammation and bone remodeling in blood
Description
MMP-3, DKK-1, IL-6, IL-17, TNF-α
Time Frame
up to 4 weeks
Title
Standard biologic evaluation of sedimentation rate
Time Frame
day 0
Title
Standard biologic evaluation of C-reactive protein
Time Frame
day 0
Title
Evaluation of spinal mobility with BASMI index
Time Frame
up to 4 weeks
Title
Evaluation of disease activity with BASDAI index
Time Frame
up to 4 weeks
Title
Evaluation of functional impact with BASFI index
Time Frame
up to 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre OLIVIER, Pr
Organizational Affiliation
CHU de Nancy, Hôpitaux de Brabois, service de Médecine Nucléaire
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Nancy, Hôpitaux de Brabois
City
Vandœuvre-lès-Nancy
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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