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NCT01889693 Clinical Trial

Imaging of Atherosclerosis With 68Ga-MSA

Atherosclerosis Clinical Trial

Official title:
Identification of Vascular Inflammatory Image Using a 68Ga-MSA(Gallium-68 Neomannosyl Human Serum Albumin) in Patients With Atherosclerotic Lesions

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01889693
Other study ID # GaMSA-Atherosclerosis
Secondary ID
Status Completed
Phase N/A
First received June 26, 2013
Last updated August 23, 2013
Start date August 2012
Est. completion date August 2013

Study information
Verified date August 2013
Source Korea University
Contact n/a
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date August 2013
Est. primary completion date August 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility 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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Korea, Republic of Korea University Guro Hospital Seoul

Sponsors (2)
Lead Sponsor Collaborator
Korea University Ministry of Health & Welfare, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
Secondary side effect of PET imaging with 68Ga-MSA any side effects including changes of biochemical values and vital signs with 7 days after PET imaging Yes
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