Clinical trial NCT05108857: PET Imaging of Systemic Sclerosis Using FDG and 68Ga-DOTA-Siglec-9
Official title: PET Imaging of Systemic Sclerosis Using 18F-FDG and 68Ga-DOTA-Siglec-9
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Systemic Sclerosis
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Kuopio University Hospital
First posted: 2021-11-05
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients of Turku University Hospital or Kuopio University Hospital with active systemic sclerosis.

Brief 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.

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.

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).

Primary outcomes:
measure: Detection of inflammation in PET/CT images
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Turku University Hospital, Turku PET Centre
Study officials:
affiliation: Turku University Hospital, Turku PET Centre
name: Anne Roivainen
role: PRINCIPAL_INVESTIGATOR
References: