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Enrolling by invitationNCT05108857SYSPETUpdated Dec 4, 2024

PET Imaging of Systemic Sclerosis Using FDG and 68Ga-DOTA-Siglec-9

An observational study in Systemic Sclerosis, sponsored by Turku University Hospital. Enrolling by invitation at 1 site in Finland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-04.

Sponsored by Turku University Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as enrolling by invitation.
Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
10
Ages
18 Years and older
Sex
All
01

Study summary

This study evaluates the potential of positron emission tomography (PET)/computed tomography (CT) imaging to monitor disease activity in patients with systemic sclerosis (SSc). PET/CT imaging will focus on two pathological features of SSc, i.e. metabolic activity evaluated by glucose analog 18F-FDG, and expression of inflammation-inducible vascular adhesion protein 1 (VAP-1) evaluated by 68Ga-DOTA-Siglec-9 tracer.

Read the detailed description

In patients with systemic sclerosis (SSc), the quantitative assessment of disease activity is still difficult. Identification of patients who unlikely respond to therapy before or early in a course of the treatment could reduce morbidity and produce cost-savings. This project will evaluate the potential of advanced functional imaging techniques to monitor disease activity. Functional imaging will focus on two pathological features of SSc, i.e. metabolic activity evaluated by glucose analog 18F-FDG positron emission tomography (PET)/computed tomography (CT), and expression of inflammation-inducible vascular adhesion protein 1 (VAP-1) evaluated by new 68Ga-DOTA-Siglec-9 tracer. If successful, the resulting techniques may prove invaluable as tools in the clinical practice and in drug research aiming to find new targets to the treatment of SSc.

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Conditions studied

  • Systemic Sclerosis
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In context

Scleroderma, Systemic

688 studies on the registry are indexed under Scleroderma, Systemic; 223 are open to participants now.

This study's planned enrollment of 10 is below the median of 100 across 169 observational studies indexed under Scleroderma, Systemic.

Browse Scleroderma, Systemic studies →

Lead sponsor

Turku University Hospital is the lead sponsor of 280 studies on the registry; 65 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients of Turku University Hospital or Kuopio University Hospital with active systemic sclerosis.

Inclusion criteria

  • Adults with active systemic sclerosis (SSc).
  • Onset of SSc (defined as first non-Raynaud symptom) not more than 5 years ago.
  • Clinically active disease with proximal nailfold capillary abnormalities detected with videocapillaroscopy and/or raised inflammatory markers (CRP or ESR).

Exclusion criteria

Exclusion Criteria:

  • Underage, pregnant, breastfeeding, handicapped or prisoner
  • History of or current inflammatory joint disease or autoimmune disease other than SSc.
  • History of treatment with, prior to this study, immunosuppressives or disease-modifying anti-rheumatic drugs (DMARDs) such as methotrexate, leflunomide, azathioprine, mycophenolate, cyclophosphamide or biologic agents such as anti-TNF inhibitors, abatacept, or rituximab. Hydroxychloroquine is allowed in the history (≥3 months prior to PET study).
  • Intra-articular or parenteral corticosteroids ≤4 weeks prior to PET/CT study.
  • Prostanoids or other vasoactive treatments like phosphodiesterase-5 inhibitors or endothelin receptor antagonists ≤4 weeks prior to PET/CT study (the use of calcium channel inhibitors is allowed).
05

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
10 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna
06

What researchers measure

Primary outcomes

  1. Detection of inflammation in PET/CT images

    Standardized uptake value of PET tracer at the sites of inflammation

    Time frame: Day 1

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Study locations

1 site
  • Turku University Hospital, Turku PET Centre
    Turku, Finland
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 4, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05108857
Lead sponsor
Turku University Hospital
Collaborators
Kuopio University Hospital
Responsible party
Sponsor
First posted
Nov 5, 2021
Start date
Nov 29, 2021
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Dec 4, 2024

Study contacts

Anne Roivainen
principal investigator · Turku University Hospital, Turku PET Centre

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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