Fluoride PET-CT imaging for the detection of bone formation in (very) early and preclinical spondyloarthritis.

Conditions: arthritis of the back
Spondyloarthritis
10023213

Registration Number: NL-OMON55045

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

- First degree relative of HLA-B27 positive AxSpA patients
- Age between 18 and 40 years at time of inclusion
- Able and willing to give written informed consent
- 10 participants with an MRI highly suggestive of SpA according to the ASAS
definition at baseline
- 10 patients without an MRI highly suggestive of SpA according to the ASAS
definition at baseline

Exclusion Criteria

- Patients already diagnosed with spondyloarthritis
- Individuals with concomitant conditions which may impact participation to the
study or interpretation of the data, such as:
- Individuals that have an arthritic disease, other than SpA
- Individuals that have a diagnosed condition with back pain other than
SpA (e.g. diagnosed intervertebral disc degenration)
- Individuals with communication problems
- Individuals with psychiatric diseases
- Individuals with drug abuse
- Individuals with a life expectancy less than 5 years
- Individuals who are pregnant or have a positive hcg urine test
- Individuals who are breastfeeding
- Individuals who have received treatment with any investigational drug
within previous 3 months
- Individuals who already received a research related radiation burden
(cumulative > 5 mSv) in the year before inclusion
- Other conditions by judgement of the physician

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Our main endpoint is [18F]Fluoride uptake present in the sternum, spine and SI<br /><br>joints on whole body PET-CT scans in 10 participants with sacroiliitis on MRI<br /><br>and 10 participants without sacroiliitis on MRI of the Pre-Spa cohort. Both<br /><br>percentage of participants with any PET-positive lesion as well as dichotomous<br /><br>scores of lesions and cumulative scores per participant will be described.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Comparison of clinical features between individuals with [18F] PET positive<br /><br>lesion and those with negative [18F]PET-CT at baseline and follow up following<br /><br>the Pre-Spa Study protocol until five years after start of the study.<br /><br>Evaluate if presence of [18F]Fluoride PET-lesions is related to molecular<br /><br>features (e.g. gene expression or serum biomarker).</p><br>