NCT05108857Enrolling by invitation
PET Imaging of Systemic Sclerosis Using FDG and 68Ga-DOTA-Siglec-9
PET Imaging of Systemic Sclerosis Using 18F-FDG and 68Ga-DOTA-Siglec-9
Source: ClinicalTrials.gov · Last updated 4 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 10 (estimated)
- First submitted
- 25 Oct 2021
- Start date
- 29 Nov 2021
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Turku University Hospital
- Diseases
- Systemic sclerosis (scleroderma)
- NCT number
- NCT05108857
What you commit to
- Study type: Observational
- Planned participants: 10
- From 29 Nov 2021 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- History of or current inflammatory joint disease or autoimmune disease other than SSc.
Lab values
- 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).
Other
- Underage, pregnant, breastfeeding, handicapped or prisoner
Who the study is looking for
- 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).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Turku University Hospital, Turku PET Centre Coordinator of this site? Confirm its status | Turku | Finland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.