Fluoride PET-CT imaging for the detection of bone formation in (very) early and preclinical spondyloarthritis
- Conditions
- Spondyloarthritis
- Registration Number
- NL-OMON25806
- Lead Sponsor
- Amsterdam UMC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 20
In order to be eligible to participate in this study, a subject must meet all of the following criteria of the original Pre-Spa cohort:
- First-degree relatives of HLA-B27 positive AxSpA patients
- Age between 18 and 40 years at time of inclusion
- Able and willing to give written informed consent .
For this specific pilot project, we include:
- 10 participants with an MRI highly suggestive of SpA according to the
ASAS definition at baseline
- 10 participants without an MRI suggestive of SpA according to the ASAS
definition at baseline.
A potential subject who meets any of the following criteria will be excluded from participation in this study:
- 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 (example: diagnosed intervertebral disc degeneration)
- Individuals with communication problems
- Individuals with psychiatric diseases
- Individuals with drug abuse
- Individuals with a life expectancy of less than five 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 mSy) in the year before inclusion
- Other conditions by judgement of the physician
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoints are, the number of individuals with positive lesions, the distribution of PET-positive lesions and the quantitative [18F]Fluoride uptake in PET-positive lesions.
- Secondary Outcome Measures
Name Time Method Comparison of clinical features between individuals with [18F] PET positive lesion and those with negative [18F]PET-CT at baseline and follow up following the Pre-Spa Study protocol until five years after start of the study.<br>Evaluate if presence of [18F]Fluoride PET-lesions is related to molecular features (e.g. gene expression or serum biomarker).