Systemic SclerosisSYSPETNCT05108857
PET Imaging of Systemic Sclerosis Using FDG and 68Ga-DOTA-Siglec-9
An observational study of Systemic Sclerosis, run by Turku University Hospital at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Sclerosis
- How many people
- 10 participants
- Where
- 1 siteFinland
- Study dates
- 29 Nov 2021to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients of Turku University Hospital or Kuopio University Hospital with active systemic sclerosis.
Who may be able to join
- 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).
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: PET Imaging of Systemic Sclerosis Using 18F-FDG and 68Ga-DOTA-Siglec-9
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.
Read the 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.
- Conditions
- Systemic Sclerosis
- Medical subject headings
- Scleroderma, Systemic
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of inflammation in PET/CT images
Standardized uptake value of PET tracer at the sites of inflammation
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2021
- Study start29 Nov 2021
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic SclerosisStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Collaborators
- Kuopio University Hospital
- Responsible party
- Sponsor
- Investigators
- Anne Roivainen, Principal investigator, Turku University Hospital, Turku PET Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05108857
- Sponsor's protocol ID
- 2110/2021
- Acronym
- SYSPET
- Status last verified
- Dec 2024
- First submitted
- 25 Oct 2021
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PET Imaging of Systemic Sclerosis Using 18F-FDG and 68Ga-DOTA-Siglec-9
- ClinicalTrials.gov ID
- NCT05108857
- Acronym / sponsor ID
- SYSPET / 2110/2021
- Conditions
- Systemic Sclerosis
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Turku University HospitalOther government
- Collaborators
- Kuopio University Hospital
- Study start
- 29 Nov 2021 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 5 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of Turku University Hospital or Kuopio University Hospital with active systemic sclerosis.
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Detection of inflammation in PET/CT images
Time frame: Day 1
Standardized uptake value of PET tracer at the sites of inflammation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anne Roivainen principal investigator
Turku University Hospital, Turku PET Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Sclerosis, run by Turku University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of inflammation in PET/CT images (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2024.