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

NCT ID: NCT05108857

Last Updated: 2024-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-29

Study Completion Date

2026-12-31

Brief Summary

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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

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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.

Conditions

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Systemic Sclerosis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kuopio University Hospital

OTHER

Sponsor Role collaborator

Turku University Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anne Roivainen

Role: PRINCIPAL_INVESTIGATOR

Turku University Hospital, Turku PET Centre

Locations

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Turku University Hospital, Turku PET Centre

Turku, , Finland

Site Status

Countries

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Finland

Other Identifiers

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2110/2021

Identifier Type: -

Identifier Source: org_study_id