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Enrolling by Invitation

NCT Number: NCT05108857

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

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.

Enrolling by Invitation

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Turku University Hospital, Turku PET Centre

Turku, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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).

Treatment and study plan

Primary outcomes

  1. Detection of inflammation in PET/CT images

    Time frame: Day 1

    Standardized uptake value of PET tracer at the sites of inflammation

Sponsors and collaborators

Lead sponsor

Turku University Hospital

Other Gov

Collaborators

  • Kuopio University Hospital

Registry information

Official study title

PET Imaging of Systemic Sclerosis Using 18F-FDG and 68Ga-DOTA-Siglec-9

Acronym: SYSPET

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Nov 5, 2021
Registry last updated
Dec 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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