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Visualization of Carotid Atherosclerosis by 68Ga-MSA

NCT ID: NCT01893489

Last Updated: 2013-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2013-08-31

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.

Detailed Description

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Conditions

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Atherosclerosis Carotid Atherosclerosis Noninvasive Imaging of Atherosclerosis

Keywords

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positron emission tomography macrophage neomannosyl human serum albumin

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Atherosclerosis

coronary artery disease patients with carotid plaques confirmed by a ultrasound study

Group Type ACTIVE_COMPARATOR

68Gallium-MSA

Intervention Type OTHER

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

control

no coronary artery disease patients without carotid plaques confirmed by a ultrasound study

Group Type SHAM_COMPARATOR

68Gallium-MSA

Intervention Type OTHER

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

Interventions

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68Gallium-MSA

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

Intervention Type OTHER

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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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SHIN JIN MEDICS

UNKNOWN

Sponsor Role collaborator

Korea University

OTHER

Sponsor Role lead

Responsible Party

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Hong Seog Seo

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Nuclear Medicine, Institute of Radiation Medicine,

Seoul, , South Korea

Site Status

Korea University Guro Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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Ga_MSA_CAD_carotid

Identifier Type: -

Identifier Source: org_study_id