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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03755245
Recruitment Status : Unknown
Verified November 2018 by Anne Roivainen, Turku University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : November 27, 2018
Last Update Posted : November 27, 2018
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, 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 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 early rheumatoid arthritis (RA). VAP-1 is abundantly expressed in synovial blood vessel in RA joints, which is why they were selected as the first patient population.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 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, and Radiation Dosimetry, Pharmacokinetics, Biodistribution, Safety and Tolerability in Healthy Men
Actual Study Start Date : November 23, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Information from the National Library of Medicine

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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

Inclusion Criteria:

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

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

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 identifier (NCT number): NCT03755245

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Turku University Hospital, Turku PET Centre
Turku, Finland
Sponsors and Collaborators
Turku University Hospital
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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 Identifier: NCT03755245    
Other Study ID Numbers: T282/2018
First Posted: November 27, 2018    Key Record Dates
Last Update Posted: November 27, 2018
Last Verified: November 2018

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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, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases