Visualization of Carotid Atherosclerosis by 68Ga-MSA
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ClinicalTrials.gov Identifier: NCT01893489 |
Recruitment Status :
Completed
First Posted : July 9, 2013
Last Update Posted : August 27, 2013
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Condition or disease | Intervention/treatment | Phase |
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Atherosclerosis Carotid Atherosclerosis Noninvasive Imaging of Atherosclerosis | Other: 68Gallium-MSA | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 12 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (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 |
Study Start Date : | September 2012 |
Actual Primary Completion Date : | August 2013 |
Actual Study Completion Date : | August 2013 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Atherosclerosis
coronary artery disease patients with carotid plaques confirmed by a ultrasound study
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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
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Other: 68Gallium-MSA
68Gallium-MSA 2.0 mci for Positron Emission Tomogram(PET) imaging |
- 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.
- standard uptake unit(SUV) at carotid arteries [ Time Frame: baseline ]
- SUV at aorta and iliac arteries [ Time Frame: baseline ]

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
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•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

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): 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 |
Responsible Party: | Hong Seog Seo, Professor of Medicine, Korea University |
ClinicalTrials.gov Identifier: | NCT01893489 |
Other Study ID Numbers: |
Ga_MSA_CAD_carotid |
First Posted: | July 9, 2013 Key Record Dates |
Last Update Posted: | August 27, 2013 |
Last Verified: | August 2013 |
positron emission tomography macrophage neomannosyl human serum albumin |
Carotid Artery Diseases Atherosclerosis Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |
Cardiovascular Diseases Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases |