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

Launched by TURKU UNIVERSITY HOSPITAL · Oct 25, 2021

Keywords

ClinConnect Summary

This study is exploring whether PET/CT imaging can help doctors monitor how active systemic sclerosis (scleroderma) is in a person. Researchers will use two special scans: one with 18F-FDG to see metabolic activity (how much the tissue is using sugar as fuel) and another with 68Ga-DOTA-Siglec-9 to look at a marker of inflammation (VAP-1). It’s an observational, cross‑sectional study at Turku University Hospital (and possibly Kuopio University Hospital) and will enroll about 10 adults with active systemic sclerosis. The main goal is to see if inflammation can be detected on the PET scans on the first day.

Who can join? Adults (18 and older) with active systemic sclerosis, whose disease started within 5 years of the first non-Raynaud symptom, and who show signs of active disease such as nailfold capillary changes or higher CRP/ESR levels. People who are pregnant, breastfeeding, under certain legal or health restrictions, or who have other inflammatory autoimmune diseases, or who have recently used certain immune‑system drugs, are not eligible. Participants may help by providing skin biopsy samples and blood serum, and they will undergo PET/CT scans as part of the study. The study is led by Turku University Hospital, with Kuopio University Hospital as a collaborator, and is not testing a treatment or a new drug. Enrollment is by invitation, with the study expected to wrap up around 2026.

Gender

ALL

Eligibility criteria

• 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).