Visualization of Carotid Atherosclerosis by 68Ga-MSA

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Atherosclerosis, Carotid Atherosclerosis, Noninvasive Imaging of Atherosclerosis

Intervention / Treatment
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* Other: 68Gallium-MSA


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Atherosclerosis<br>coronary artery disease patients with carotid plaques confirmed by a ultrasound study | Other: 68Gallium-MSA<br>* 68Gallium-MSA 2.0 mci for Positron Emission Tomogram(PET) imaging<br>|
| Sham Comparator: control<br>no coronary artery disease patients without carotid plaques confirmed by a ultrasound study | Other: 68Gallium-MSA<br>* 68Gallium-MSA 2.0 mci for Positron Emission Tomogram(PET) imaging<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| standard uptake unit(SUV) at carotid arteries |  | baseline | 
| SUV at aorta and iliac arteries |  | baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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macrophage, positron emission tomography, neomannosyl human serum albumin