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

Systemic Sclerosis Clinical Trial

— SYSPET  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05108857
• Other study ID #: 2110/2021
• Status: Enrolling by invitation
• Start date: November 29, 2021
• Est. completion date: December 31, 2026

Study information

• Verified date: October 2023
• Source: Turku University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 10
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sclerosis
• Systemic Sclerosis

Locations

Country	Name	City	State
Finland	Turku University Hospital, Turku PET Centre	Turku

Sponsors (2)

Lead Sponsor	Collaborator
Turku University Hospital	Kuopio University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection of inflammation in PET/CT images	Standardized uptake value of PET tracer at the sites of inflammation	Day 1