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Visualization of Carotid Atherosclerosis by 68Ga-MSA

This study has been completed.
Information provided by (Responsible Party):
Hong Seog Seo, Korea University Identifier:
First received: June 27, 2013
Last updated: August 23, 2013
Last verified: August 2013
Until now, no specific atherosclerosis-targeting agent labeled with positron emitter is not yet available. Investigators developed neomannosyl human serum albumin(MSA) for the terminal mannose residues of MSA binding with the mannose receptors of macrophages in atherosclerosis, and investigators investigate whether 68Ga-MSA can be a novel agent for non-invasive molecular imaging of carotid atherosclerotic lesion in PET.

Condition Intervention Phase
Carotid Atherosclerosis
Noninvasive Imaging of Atherosclerosis
Other: 68Gallium-MSA
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Phase I Study to Evaluated the Safety of Noninvasive Molecular Imaging for the Detection of Inflammation in Carotid Atherosclerotic Lesions by Using Ga-68-NOTA-MSA in Healthy Volunteers and Patients With Coronary Artery Disease

Resource links provided by NLM:

Further study details as provided by Korea University:

Primary Outcome Measures:
  • side reactions at MSA injection site of the skin [ Time Frame: with 2 hours after MSA injection ]
    development of unexpected skin rashes or other skin lesions at MSA injection site of the skin with 2 hours after MSA injection

  • unstable changes of vital signs and development of abnormal biochemical parameters [ Time Frame: 24 hours after MSA injection ]
    This includes unstable changes of vital signs including blood pressure, body temperature and heart rate, and abnormal changes of biochemical parameters such as hematologic, hepatic and renal functions.

Secondary Outcome Measures:
  • standard uptake unit(SUV) at carotid arteries [ Time Frame: baseline ]
  • SUV at aorta and iliac arteries [ Time Frame: baseline ]

Enrollment: 12
Study Start Date: September 2012
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Atherosclerosis
coronary artery disease patients with carotid plaques confirmed by a ultrasound study
Other: 68Gallium-MSA
68Gallium-MSA 2.0 mci for Positron Emission Tomogram(PET) imaging
Sham Comparator: control
no coronary artery disease patients without carotid plaques confirmed by a ultrasound study
Other: 68Gallium-MSA
68Gallium-MSA 2.0 mci for Positron Emission Tomogram(PET) imaging


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • •coronary artery disease patients with carotid plaques

    • control without carotid plaque

Exclusion Criteria:

  • •pregnancy, allergy to albumin, any acute or chronic inflammatory disease, hematologic disease, liver disease, renal disease
  Contacts and Locations
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Please refer to this study by its identifier: NCT01893489

Korea, Republic of
Department of Nuclear Medicine, Institute of Radiation Medicine,
Seoul, Korea, Republic of, 110-744
Korea University Guro Hospital
Seoul, Korea, Republic of, 152-703
Sponsors and Collaborators
Korea University
  More Information

Responsible Party: Hong Seog Seo, Professor of Medicine, Korea University Identifier: NCT01893489     History of Changes
Other Study ID Numbers: Ga_MSA_CAD_carotid
Study First Received: June 27, 2013
Last Updated: August 23, 2013

Keywords provided by Korea University:
positron emission tomography
neomannosyl human serum albumin

Additional relevant MeSH terms:
Carotid Artery Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases processed this record on May 23, 2017