SpondyloarthritisFNaNCT02869100
Comparison of Sodium Fluoride Positron Emission Tomography and Magnetic Resonance Imaging of Spine and Sacroiliac Joints for Detection of Inflammatory Lesions in Spondyloarthritis Patients
A study testing Blood sample, Sodium fluoride Positron Emission Tomography and Magnetic Resonance Imaging in people with Spondyloarthritis, run by Central Hospital, Nancy, France at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spondyloarthritis
- What is being tested?
- Blood sample, Sodium fluoride Positron Emission Tomography and Magnetic Resonance Imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2013to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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
- Being tested
- Blood sample, Sodium fluoride Positron Emission Tomography, Magnetic Resonance Imaging, Radiography
- Keywords
- magnetic resonance imaging, sodium fluoride positron emission tomography
- Medical subject headings
- Spondylarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleOther
Sodium fluoride Positron Emission TomographyProcedure or surgery
Magnetic Resonance ImagingOther
RadiographyOther
| Study group | Role | What they receive |
|---|---|---|
| Spondyloarthritis Patients | Experimental | Not described Receives: Other: Blood sample; Procedure: Sodium fluoride Positron Emission Tomography; Other: Magnetic Resonance Imaging; Other: Radiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: up to 4 weeks
Secondary outcomes (9)
Structural evaluation with New York score
Measured: day 0
Structural evaluation with mSASSS scores
Measured: day 0
Structural evaluation with BASRI score
Measured: day 0
Levels of specific biologic markers of inflammation and bone remodeling in blood
MMP-3, DKK-1, IL-6, IL-17, TNF-α
Measured: up to 4 weeks
Standard biologic evaluation of sedimentation rate
Measured: day 0
Standard biologic evaluation of C-reactive protein
Measured: day 0
Evaluation of spinal mobility with BASMI index
Measured: up to 4 weeks
Evaluation of disease activity with BASDAI index
Measured: up to 4 weeks
Evaluation of functional impact with BASFI index
Measured: up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2016 (estimated)
- Study startJan 2013
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpondyloarthritisStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre OLIVIER, Pr, Principal investigator, CHU de Nancy, Hôpitaux de Brabois, service de Médecine Nucléaire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02869100
- Sponsor's protocol ID
- 2012-A00568-35
- Acronym
- FNa
- Status last verified
- Aug 2016
- First submitted
- 9 Aug 2016
- Last updated
- 16 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02869100
- Acronym / sponsor ID
- FNa / 2012-A00568-35
- Conditions
- Spondyloarthritis
- Keywords
- magnetic resonance imaging, sodium fluoride positron emission tomography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 16 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spondyloarthritis Patients | Experimental | Other: Blood sample, Procedure: Sodium fluoride Positron Emission Tomography, Other: Magnetic Resonance Imaging, Other: Radiography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sample | Other | Spondyloarthritis Patients |
| Sodium fluoride Positron Emission Tomography | Procedure or surgery | Spondyloarthritis Patients |
| Magnetic Resonance Imaging | Other | Spondyloarthritis Patients |
| Radiography | Other | Spondyloarthritis Patients |
Primary outcome
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)
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
9 secondary outcomes
Structural evaluation with New York score
Time frame: day 0
Structural evaluation with mSASSS scores
Time frame: day 0
Structural evaluation with BASRI score
Time frame: day 0
Levels of specific biologic markers of inflammation and bone remodeling in blood
Time frame: up to 4 weeks
Standard biologic evaluation of sedimentation rate
Time frame: day 0
Standard biologic evaluation of C-reactive protein
Time frame: day 0
Evaluation of spinal mobility with BASMI index
Time frame: up to 4 weeks
Evaluation of disease activity with BASDAI index
Time frame: up to 4 weeks
Evaluation of functional impact with BASFI index
Time frame: up to 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre OLIVIER, Pr principal investigator
CHU de Nancy, Hôpitaux de Brabois, service de Médecine Nucléaire
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample, Sodium fluoride Positron Emission Tomography and Magnetic Resonance Imaging in people with Spondyloarthritis, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concordance between binary topographic evaluations of bone inflammation in PET data and MRI data (time frame: up to 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2016.