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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON25806
Enrollment
20
Registered
2021-08-12
Start date
2021-05-05
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spondyloarthritis

Interventions

None listed

Sponsors

Amsterdam UMC
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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. Evaluate if presence of [18F]Fluoride PET-lesions is related to molecular features (e.g. gene expression or serum biomarker).

Contacts

Public ContactJerney de Jongh

VUmc

j.dejongh2@amsterdamumc.nl020-4443981

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)