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Imaging of Atherosclerosis With 68Ga-MSA

Sponsor
Korea University (Other)
Overall Status
Completed
CT.gov ID
NCT01889693
Collaborator
Ministry of Health & Welfare, Korea (Other)
60
Enrollment
1
Location
12
Duration (Months)
5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Despite of intensive efforts, no specific ath¬erosclerosis-targeting agent labeled with positron emitter is not yet available. Fortunately, some scientists made the major advance in the field of clinical atherosclerosis molecular imaging by the metabolic PET reporter agent 18F(fluorine-18)-FDG(Fludeoxyglucose) applied to noninvasively image plaque macrophages in carotid arteries. However, coronary and cerebral arterial segments remain uninterpretable due to metabolic property of 18F-FDG. Applying the character of the terminal mannose residues of MSA binding with the mannose receptors of macrophages in atherosclerosis, we investigate whether 68Ga-MSA can be a novel agent for non-invasive molecular imaging of atherosclerotic lesion in PET.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    60 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Identification of Vascular Inflammatory Image Using a 68Ga-MSA(Gallium-68 Neomannosyl Human Serum Albumin) in Patients With Atherosclerotic Lesions
    Study Start Date :
    Aug 1, 2012
    Actual Primary Completion Date :
    Aug 1, 2013
    Actual Study Completion Date :
    Aug 1, 2013

    Arms and Interventions

    Arm Intervention/Treatment
    acute coronary syndrome

    patients with acute myocardial infarction and unstable angina
    chronic stable angina

    patients with chronic stable angina
    control

    control subjects without coronary artery disease

    Outcome Measures

    Primary Outcome Measures

    1. comparison of SUV(standard uptake unit) at atherosclerotic plaque of aorta and carotid arteries among 3 groups [1 day at the time of PET(positron emission tomogram) imaging]

    Secondary Outcome Measures

    1. side effect of PET imaging with 68Ga-MSA [with 7 days after PET imaging]

      any side effects including changes of biochemical values and vital signs

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • acute coronary syndrome(acute myocardial infarction, unstable angina)

    • chronic stable angina

    • control without coronary artery disease

    Exclusion Criteria:
    • pregnancy, allergy to albumin, chronic inflammatory disease

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Korea University Guro Hospital Seoul Korea, Republic of 152-703

    Sponsors and Collaborators

    • Korea University
    • Ministry of Health & Welfare, Korea

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hong Seog Seo, Professor of Medicine, Korea University
    ClinicalTrials.gov Identifier:
    NCT01889693
    Other Study ID Numbers:
    • GaMSA-Atherosclerosis
    First Posted:
    Jun 28, 2013
    Last Update Posted:
    Aug 27, 2013
    Last Verified:
    Aug 1, 2013
    Keywords provided by Hong Seog Seo, Professor of Medicine, Korea University
    positron emission tomography
    macrophage
    neomannosyl human serum albumin
    Additional relevant MeSH terms:
    Atherosclerosis

    Study Results

    No Results Posted as of Aug 27, 2013