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

Rheumatoid Arthritis Clinical Trial

— SIGLEC  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03755245
• Other study ID #: T282/2018
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 23, 2018
• Est. completion date: December 2023

Study information

• Verified date: October 2022
• Source: Turku University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 tolerability of the tracer in healthy volunteers.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 26
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Healthy Subjects
• Pulmonary Sarcoidosis
• Rheumatoid Arthritis
• Sarcoidosis
• Sarcoidosis, Pulmonary
• Vasculitis

Intervention

Other:
• [68Ga]Ga-DOTA-Siglec-9
Vascular Adhesion Protein 1 (VAP-1) targeted radiopharmaceutical

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Turku University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	within a week