Visualization of Carotid Atherosclerosis by 68Ga-MSA

This study has been completed.

Sponsor:

Collaborator:

SHIN JIN MEDICS

Information provided by (Responsible Party):

Hong Seog Seo, Korea University

ClinicalTrials.gov Identifier:

NCT01893489

First received: June 27, 2013

Last updated: August 23, 2013

Last verified: August 2013

History of Changes

Purpose

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.

Condition	Intervention	Phase
Atherosclerosis Carotid Atherosclerosis Noninvasive Imaging of Atherosclerosis	Other: 68Gallium-MSA	Phase 1


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

Resource links provided by NLM:

MedlinePlus related topics: Atherosclerosis

U.S. FDA Resources

Further study details as provided by Korea University:

Primary Outcome Measures:

side reactions at MSA injection site of the skin [ Time Frame: with 2 hours after MSA injection ] [ Designated as safety issue: Yes ]
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 [ Time Frame: 24 hours after MSA injection ] [ Designated as safety issue: Yes ]
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 [ Time Frame: baseline ] [ Designated as safety issue: No ]
SUV at aorta and iliac arteries [ Time Frame: baseline ] [ Designated as safety issue: No ]


Enrollment:	12
Study Start Date:	September 2012
Study Completion Date:	August 2013
Primary Completion Date:	August 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Atherosclerosis coronary artery disease patients with carotid plaques confirmed by a ultrasound study	Other: 68Gallium-MSA 68Gallium-MSA 2.0 mci for Positron Emission Tomogram(PET) imaging Other Name: 68Gallium-MSA
Sham Comparator: control no coronary artery disease patients without carotid plaques confirmed by a ultrasound study	Other: 68Gallium-MSA 68Gallium-MSA 2.0 mci for Positron Emission Tomogram(PET) imaging Other Name: 68Gallium-MSA

Eligibility


Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01893489

Locations


Korea, Republic of
Department of Nuclear Medicine, Institute of Radiation Medicine,
Seoul, Korea, Republic of, 110-744
Korea University Guro Hospital
Seoul, Korea, Republic of, 152-703

Sponsors and Collaborators

Korea University

SHIN JIN MEDICS

More Information

No publications provided


Responsible Party:	Hong Seog Seo, Professor of Medicine, Korea University
ClinicalTrials.gov Identifier:	NCT01893489 History of Changes
Other Study ID Numbers:	Ga_MSA_CAD_carotid
Study First Received:	June 27, 2013
Last Updated:	August 23, 2013
Health Authority:	Korea: Food and Drug Administration

Keywords provided by Korea University:


positron emission tomography macrophage neomannosyl human serum albumin

Additional relevant MeSH terms:


Arteriosclerosis Atherosclerosis Carotid Artery Diseases Arterial Occlusive Diseases Brain Diseases	Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

ClinicalTrials.gov processed this record on February 25, 2015

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