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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01893489
Other study ID # Ga_MSA_CAD_carotid
Secondary ID
Status Completed
Phase Phase 1
First received June 27, 2013
Last updated August 23, 2013
Start date September 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 Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 12
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:

- •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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

Other:
68Gallium-MSA
68Gallium-MSA 2.0 mci for Positron Emission Tomogram(PET) imaging

Locations

Country Name City State
Korea, Republic of Department of Nuclear Medicine, Institute of Radiation Medicine, Seoul
Korea, Republic of Korea University Guro Hospital Seoul

Sponsors (2)

Lead Sponsor Collaborator
Korea University SHIN JIN MEDICS

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary side reactions at MSA injection site of the skin development of unexpected skin rashes or other skin lesions at MSA injection site of the skin with 2 hours after MSA injection with 2 hours after MSA injection Yes
Primary unstable changes of vital signs and development of abnormal biochemical parameters 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. 24 hours after MSA injection Yes
Secondary standard uptake unit(SUV) at carotid arteries baseline No
Secondary SUV at aorta and iliac arteries baseline No
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