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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. - [18F]Fluoride PET in pre-SpA

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON55045
Enrollment
20
Registered
2020-10-09
Start date
2021-02-01
Completion date
Unknown
Last updated
2024-04-15

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

Conditions

arthritis of the back Spondyloarthritis

Interventions

None listed

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

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

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).

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)