Biodistribution, Dosimetry and Performance of [68Ga]Ga-DOTA-Siglec-9 in Healthy and Patients With Rheumatoid Arthritis, Vasculitis or Pulmonary Sarcoidosis

NCT03755245 | Enrolling By Invitation

• 1 other identifier: T282/2018
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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 tolerability of the tracer in healthy volunteers.

Conditions

Healthy Subjects; Rheumatoid Arthritis; Vasculitis; Pulmonary Sarcoidosis

Outcome Measures

Primary Outcomes (1)

• Whole-body distribution of [68Ga]Ga-DOTA-Siglec-9

  Knowledge how intravenously injected \[68Ga\]Ga-DOTA-Siglec-9 is distributed in human body

  within a day

Secondary Outcomes (1)

• Radiation dosimetry of [68Ga]Ga-DOTA-Siglec-9

  within a week

Study Arms (1)

[68Ga]Ga-DOTA-Siglec-9

OTHER

Intravenous 140 MBq bolus injection of \[68Ga\]Ga-DOTA-Siglec-9 radiopharmaceutical

Other: [68Ga]Ga-DOTA-Siglec-9

Interventions

[68Ga]Ga-DOTA-Siglec-9 OTHER

Vascular Adhesion Protein 1 (VAP-1) targeted radiopharmaceutical

[68Ga]Ga-DOTA-Siglec-9

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy 18-70 year-old men
• Male or female 18-70 year-old patients with active rheumatoid arthritis, vasculitis or pulmonary sarcoidosis

You may not qualify if:

• 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

Sponsors & Collaborators

• Turku University Hospital: lead

Study Sites (1)

Turku University Hospital, Turku PET Centre

Turku, Finland

Location

Related Publications (1)

• 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. doi: 10.1186/s12931-025-03455-8. Online ahead of print.

  PMID: 41420234 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid; Vasculitis; Sarcoidosis, Pulmonary

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Vascular Diseases; Cardiovascular Diseases; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Sarcoidosis; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Delayed; Hypersensitivity

Study Officials

• Anne Roivainen, Professor

  Turku University Hospital, Turku PET Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Whole-body distribution, plasma pharmacokinetics, radiation dosimetry, safety, tolerability and performance of \[68Ga\]Ga-DOTA-Siglec-9

Study Record Dates

• First Submitted: November 23, 2018
• First Posted: November 27, 2018
• Study Start: November 23, 2018
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 25, 2024

Record last verified: 2024-11

Locations

FI (1)