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

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ClinicalTrials.gov Identifier: NCT03755245
Recruitment Status : Recruiting
First Posted : November 27, 2018
Last Update Posted : June 11, 2021
Sponsor:
Information provided by (Responsible Party):
Anne Roivainen, Turku University Hospital

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.

Condition or disease Intervention/treatment Phase
Healthy Subjects Rheumatoid Arthritis Vasculitis Pulmonary Sarcoidosis Other: [68Ga]Ga-DOTA-Siglec-9 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Whole-body distribution, plasma pharmacokinetics, radiation dosimetry, safety, tolerability and performance of [68Ga]Ga-DOTA-Siglec-9
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : November 23, 2018
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
[68Ga]Ga-DOTA-Siglec-9
Intravenous 140 MBq bolus injection of [68Ga]Ga-DOTA-Siglec-9 radiopharmaceutical
Other: [68Ga]Ga-DOTA-Siglec-9
Vascular Adhesion Protein 1 (VAP-1) targeted radiopharmaceutical




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Radiation dosimetry of [68Ga]Ga-DOTA-Siglec-9 [ Time Frame: within a week ]
    Absorbed ionisation radiation dose in critical organs due to single intravenous 140 megabecquerel injection of [68Ga]Ga-DOTA-Siglec-9



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03755245


Contacts
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Contact: Roivainen +358-2-3130000 contact.pet@tyks.fi

Locations
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Finland
Turku University Hospital, Turku PET Centre Recruiting
Turku, Finland
Contact: Roivainen    +358-2-3130000      
Sponsors and Collaborators
Turku University Hospital
Investigators
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Principal Investigator: Anne Roivainen, Professor Turku University Hospital, Turku PET Centre
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Responsible Party: Anne Roivainen, Professor, Turku University Hospital
ClinicalTrials.gov Identifier: NCT03755245    
Other Study ID Numbers: T282/2018
First Posted: November 27, 2018    Key Record Dates
Last Update Posted: June 11, 2021
Last Verified: June 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Sarcoidosis, Pulmonary
Vasculitis
Sarcoidosis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Lymphoproliferative Disorders
Lymphatic Diseases
Vascular Diseases
Cardiovascular Diseases
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases