Visualization of Carotid Atherosclerosis by 68Ga-MSA

Phase 1

Completed

• Conditions: Atherosclerosis; Carotid Atherosclerosis; Noninvasive Imaging of Atherosclerosis
• Interventions: Other: 68Gallium-MSA

• Registration Number: NCT01893489
• Lead Sponsor: Korea University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2013-06-27
• Study First Submitted QC: 2013-07-02
• Study First Posted: 2013-07-09
• Status Verified: 2013-08
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Last Update Submitted: 2013-08-23
• Last Update Posted: 2013-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Atherosclerosis	68Gallium-MSA	coronary artery disease patients with carotid plaques confirmed by a ultrasound study
control	68Gallium-MSA	no coronary artery disease patients without carotid plaques confirmed by a ultrasound study

Primary Outcome Measures

Name	Time	Method
side reactions at MSA injection site of the skin	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	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

Name	Time	Method
standard uptake unit(SUV) at carotid arteries	baseline
SUV at aorta and iliac arteries	baseline

Trial Locations

Locations (2)

Department of Nuclear Medicine, Institute of Radiation Medicine,; 🇰🇷 Seoul, Korea, Republic of

Korea University Guro Hospital; 🇰🇷 Seoul, Korea, Republic of