Healthy SubjectsSIGLECNCT03755245
Biodistribution, Dosimetry and Performance of [68Ga]Ga-DOTA-Siglec-9 in Healthy and Patients With Rheumatoid Arthritis, Vasculitis or Pulmonary Sarcoidosis
A study testing [68Ga]Ga-DOTA-Siglec-9 in people with Healthy Subjects and Rheumatoid Arthritis, run by Turku University Hospital at 1 site in Finland.
Trial summary
This study evaluates safety, tolerability, biodistribution and performance of the [68Ga]Ga-DOTA-Siglec-9 following a single intravenous administration in patients with active rheumatoid arthritis, vasculitis or pulmonary sarcoidosis as well as radiation dosimetry, plasma pharmacokinetics, biodistribution, safety and… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects, Rheumatoid Arthritis, Vasculitis
- What is being tested?
- [68Ga]Ga-DOTA-Siglec-9
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteFinland
- Study dates
- 23 Nov 2018to Dec 2025
- Phase
- Interventional
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy 18-70 year-old men
- Male or female 18-70 year-old patients with active rheumatoid arthritis, vasculitis or pulmonary sarcoidosis
Who cannot join
- In healthy: ongoing infection/inflammation proven by blood or other tests
- In patients with rheumatoid arthritis: no treatment with disease-modifying anti-rheumatic drugs or biologic agents, and no corticosteroids for 2 weeks prior the study
- In patients with vasculitis: no immunosuppressives, and glucocorticoid less than 60 mg for 2 weeks or NSAIDs for 1 day prior the study
- In patients with pulmonary sarcoidosis: no corticosteroids for 1 week or NSAIDs for day prior the study
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/CT Study of Biodistribution and Performance of the [68Ga]Ga-DOTA-Siglec-9 in Patients With Rheumatoid Arthritis,Vasculitis or Pulmonary Sarcoidosis, and Radiation Dosimetry, Pharmacokinetics, Biodistribution, Safety and Tolerability in Healthy Men
This study evaluates safety, tolerability, biodistribution and performance of the [68Ga]Ga-DOTA-Siglec-9 following a single intravenous administration in patients with active rheumatoid arthritis, vasculitis or pulmonary sarcoidosis as well as radiation dosimetry, plasma pharmacokinetics, biodistribution, safety and tolerability of the tracer in healthy volunteers.
Read the detailed description
Vascular adhesion protein 1 (VAP-1) is an inflammation inducible endothelial cell molecule mediating leukocyte trafficking from blood into the sites of inflammation. Although VAP-1 plays important role in early phases of inflammation, its luminal expression on the endothelium will remain constant if the inflammation continues, which suggest VAP-1 as a promising target for molecular imaging of inflammation. We have previously shown that sialic acid-binding immunoglobulin-like lectin 9 (Siglec-9) is a VAP-1 ligand, and the gallium-68 labeled 1,4,7,10-tetraazacyclododecane-N,N´,N´´,N´´´-tetraacetic acid conjugated peptide ([68Ga]Ga-DOTA-Siglec-9) containing residues 283-297 from Siglec-9 can be used for PET imaging of inflammation in various experimental models. This first-in-human study evaluates safety, tolerability, biodistribution and performance of [68Ga]Ga-DOTA-Siglec-9 after single intravenous injection in six healthy volunteers, and in ten patients with active rheumatoid arthritis (RA), five patients with vasculitis and five patients with pulmonary sarcoidosis.
- Being tested
- [68Ga]Ga-DOTA-Siglec-9
- Medical subject headings
- Arthritis, Rheumatoid, Vasculitis, Sarcoidosis, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[68Ga]Ga-DOTA-Siglec-9Other
Vascular Adhesion Protein 1 (VAP-1) targeted radiopharmaceutical
| Study group | Role | What they receive |
|---|---|---|
| [68Ga]Ga-DOTA-Siglec-9 | Other | Intravenous 140 MBq bolus injection of [68Ga]Ga-DOTA-Siglec-9 radiopharmaceutical Receives: Other: [68Ga]Ga-DOTA-Siglec-9 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole-body distribution of [68Ga]Ga-DOTA-Siglec-9
Knowledge how intravenously injected [68Ga]Ga-DOTA-Siglec-9 is distributed in human body
Measured: within a day
Secondary outcomes (1)
Radiation dosimetry of [68Ga]Ga-DOTA-Siglec-9
Absorbed ionisation radiation dose in critical organs due to single intravenous 140 megabecquerel injection of [68Ga]Ga-DOTA-Siglec-9
Measured: within a week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2018
- Study start23 Nov 2018
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Whole-body distribution, plasma pharmacokinetics, radiation dosimetry, safety, tolerability and performance of \[68Ga\]Ga-DOTA-Siglec-9
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Anne Roivainen, Turku University Hospital
- Investigators
- Anne Roivainen, Professor, Principal investigator, Turku University Hospital, Turku PET Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03755245
- Sponsor's protocol ID
- T282/2018
- Acronym
- SIGLEC
- Status last verified
- Nov 2024
- First submitted
- 23 Nov 2018
- Last updated
- 25 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dadson P, Yla-Outinen H, Kalliokoski K, Tuokkola T, Malaspina S, Koivumaki M, Viitanen R, Rajala N, Silvoniemi M, Tolvanen T, Nuutila P, Jalkanen S, Saraste A, Saaresranta T, Taimen P, Roivainen A. Proof-of-concept PET imaging of pulmonary sarcoidosis using VAP-1-targeted radiotracer [68Ga]Ga-DOTA-Siglec-9. Respir Res. 2025 Dec 19;27(1):124. doi: 10.1186/s12931-025-03455-8.
PubMed 41420234
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PET/CT Study of Biodistribution and Performance of the [68Ga]Ga-DOTA-Siglec-9 in Patients With Rheumatoid Arthritis,Vasculitis or Pulmonary Sarcoidosis, and Radiation Dosimetry, Pharmacokinetics, Biodistribution, Safety and Tolerability in Healthy Men
- ClinicalTrials.gov ID
- NCT03755245
- Acronym / sponsor ID
- SIGLEC / T282/2018
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Turku University HospitalOther government
- Study start
- 23 Nov 2018 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 27 Nov 2018 (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 safety, tolerability, biodistribution and performance of the [68Ga]Ga-DOTA-Siglec-9 following a single intravenous administration in patients with active rheumatoid arthritis, vasculitis or pulmonary sarcoidosis as well as radiation dosimetry, plasma pharmacokinetics, biodistribution, safety and tolerability of the tracer in healthy volunteers.
Detailed description
Vascular adhesion protein 1 (VAP-1) is an inflammation inducible endothelial cell molecule mediating leukocyte trafficking from blood into the sites of inflammation. Although VAP-1 plays important role in early phases of inflammation, its luminal expression on the endothelium will remain constant if the inflammation continues, which suggest VAP-1 as a promising target for molecular imaging of inflammation. We have previously shown that sialic acid-binding immunoglobulin-like lectin 9 (Siglec-9) is a VAP-1 ligand, and the gallium-68 labeled 1,4,7,10-tetraazacyclododecane-N,N´,N´´,N´´´-tetraacetic acid conjugated peptide ([68Ga]Ga-DOTA-Siglec-9) containing residues 283-297 from Siglec-9 can be used for PET imaging of inflammation in various experimental models. This first-in-human study evaluates safety, tolerability, biodistribution and performance of [68Ga]Ga-DOTA-Siglec-9 after single intravenous injection in six healthy volunteers, and in ten patients with active rheumatoid arthritis (RA), five patients with vasculitis and five patients with pulmonary sarcoidosis.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Whole-body distribution, plasma pharmacokinetics, radiation dosimetry, safety, tolerability and performance of [68Ga]Ga-DOTA-Siglec-9
| Arm | Type | Receives |
|---|---|---|
| [68Ga]Ga-DOTA-Siglec-9 | Other | Other: [68Ga]Ga-DOTA-Siglec-9Intravenous 140 MBq bolus injection of [68Ga]Ga-DOTA-Siglec-9 radiopharmaceutical |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy 18-70 year-old men
- Male or female 18-70 year-old patients with active rheumatoid arthritis, vasculitis or pulmonary sarcoidosis
Key exclusion criteria (4 listed)
- In healthy: ongoing infection/inflammation proven by blood or other tests
- In patients with rheumatoid arthritis: no treatment with disease-modifying anti-rheumatic drugs or biologic agents, and no corticosteroids for 2 weeks prior the study
- In patients with vasculitis: no immunosuppressives, and glucocorticoid less than 60 mg for 2 weeks or NSAIDs for 1 day prior the study
- In patients with pulmonary sarcoidosis: no corticosteroids for 1 week or NSAIDs for day prior the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [68Ga]Ga-DOTA-Siglec-9Vascular Adhesion Protein 1 (VAP-1) targeted radiopharmaceutical | Other | [68Ga]Ga-DOTA-Siglec-9 |
Primary outcome
Whole-body distribution of [68Ga]Ga-DOTA-Siglec-9
Time frame: within a day
Knowledge how intravenously injected [68Ga]Ga-DOTA-Siglec-9 is distributed in human body
1 secondary outcome
Radiation dosimetry of [68Ga]Ga-DOTA-Siglec-9
Time frame: within a week
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 25 Nov 2024.
- Derived from this study: PubMed 41420234Dadson P, Yla-Outinen H, Kalliokoski K, Tuokkola T, Malaspina S, Koivumaki M, Viitanen R, Rajala N, Silvoniemi M, Tolvanen T, Nuutila P, Jalkanen S, Saraste A, Saaresranta T, Taimen P, Roivainen A. Proof-of-concept PET imaging of pulmonary sarcoidosis using VAP-1-targeted radiotracer [68Ga]Ga-DOTA-Siglec-9. Respir Res. 2025 Dec 19;27(1):124. doi: 10.1186/s12931-025-03455-8.
Related trials for Healthy Subjects
Enrolling by invitationObservational study
Collection of Tissue Specimens From Patients With Solid Tumors or Blood Disorders and Their HLA-Compatible Family Members
Neoplasms, Hematologic Neoplasms
Enrolling by invitationObservational study
Collection and Distribution of Samples From Healthy Donors for In Vitro Research at the NCI-Frederick
Healthy Donors
RecruitingObservational study
Oral Bacteria and Immune System Problems Involved in Gum Disease (Periodontitis)
Immunosuppression, Periodontal Disease
RecruitingObservational study
Adaptive Optics Retinal Imaging
Eye Diseases, Healthy Volunteers
RecruitingObservational study
Characterization of Diseases With Salivary Gland Involvement
Healthy Volunteer, Sjogren's Syndrome
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, Professor 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?
A study testing [68Ga]Ga-DOTA-Siglec-9 in people with Healthy Subjects and Rheumatoid Arthritis, 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 2 inclusion and 4 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 25 Nov 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?
Whole-body distribution of [68Ga]Ga-DOTA-Siglec-9 (time frame: within a day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03755245, which also lists 1 linked publication.
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 25 Nov 2024; AzTrials last refreshed its copy on 26 Oct 2026.