Clinical trial NCT03755245: Biodistribution, Dosimetry and Performance of [68Ga]Ga-DOTA-Siglec-9 in Healthy and Patients With Rheumatoid Arthritis, Vasculitis or Pulmonary Sarcoidosis
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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Healthy Subjects
Rheumatoid Arthritis
Vasculitis
Pulmonary Sarcoidosis
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
First posted: 2018-11-27
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Whole-body distribution, plasma pharmacokinetics, radiation dosimetry, safety, tolerability and performance of \[68Ga\]Ga-DOTA-Siglec-9
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Whole-body distribution of [68Ga]Ga-DOTA-Siglec-9
timeFrame: within a day
Secondary outcomes:
measure: Radiation dosimetry of [68Ga]Ga-DOTA-Siglec-9
timeFrame: within a week
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Turku University Hospital, Turku PET Centre
Study officials:
affiliation: Turku University Hospital, Turku PET Centre
name: Anne Roivainen, Professor
role: PRINCIPAL_INVESTIGATOR
References: