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Visualization of Carotid Atherosclerosis by 68Ga-MSA

Primary Purpose

Atherosclerosis, Carotid Atherosclerosis, Noninvasive Imaging of Atherosclerosis

Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
68Gallium-MSA
Sponsored by
Korea University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Atherosclerosis focused on measuring positron emission tomography, macrophage, neomannosyl human serum albumin

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Department of Nuclear Medicine, Institute of Radiation Medicine,
  • Korea University Guro Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Atherosclerosis

control

Arm Description

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

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

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

standard uptake unit(SUV) at carotid arteries
SUV at aorta and iliac arteries

Full Information

First Posted
June 27, 2013
Last Updated
August 23, 2013
Sponsor
Korea University
Collaborators
SHIN JIN MEDICS
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1. Study Identification

Unique Protocol Identification Number
NCT01893489
Brief Title
Visualization of Carotid Atherosclerosis by 68Ga-MSA
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Korea University
Collaborators
SHIN JIN MEDICS

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis, Carotid Atherosclerosis, Noninvasive Imaging of Atherosclerosis
Keywords
positron emission tomography, macrophage, neomannosyl human serum albumin

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Atherosclerosis
Arm Type
Active Comparator
Arm Description
coronary artery disease patients with carotid plaques confirmed by a ultrasound study
Arm Title
control
Arm Type
Sham Comparator
Arm Description
no coronary artery disease patients without carotid plaques confirmed by a ultrasound study
Intervention Type
Other
Intervention Name(s)
68Gallium-MSA
Intervention Description
68Gallium-MSA 2.0 mci for Positron Emission Tomogram(PET) imaging
Primary Outcome Measure Information:
Title
side reactions at MSA injection site of the skin
Description
development of unexpected skin rashes or other skin lesions at MSA injection site of the skin with 2 hours after MSA injection
Time Frame
with 2 hours after MSA injection
Title
unstable changes of vital signs and development of abnormal biochemical parameters
Description
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.
Time Frame
24 hours after MSA injection
Secondary Outcome Measure Information:
Title
standard uptake unit(SUV) at carotid arteries
Time Frame
baseline
Title
SUV at aorta and iliac arteries
Time Frame
baseline

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Department of Nuclear Medicine, Institute of Radiation Medicine,
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Korea University Guro Hospital
City
Seoul
ZIP/Postal Code
152-703
Country
Korea, Republic of

12. IPD Sharing Statement

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Visualization of Carotid Atherosclerosis by 68Ga-MSA

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