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Completed

NCT Number: NCT01893489

Visualization of Carotid Atherosclerosis by 68Ga-MSA

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Department of Nuclear Medicine, Institute of Radiation Medicine,, Seoul, South Korea

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

68Gallium-MSA

Other

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

Primary outcomes

  1. side reactions at MSA injection site of the skin

    Time frame: 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

  2. unstable changes of vital signs and development of abnormal biochemical parameters

    Time frame: 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 outcomes

  1. standard uptake unit(SUV) at carotid arteries

    Time frame: baseline

  2. SUV at aorta and iliac arteries

    Time frame: baseline

Sponsors and collaborators

Lead sponsor

Korea University

Other

Collaborators

  • SHIN JIN MEDICS

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jul 9, 2013
Registry last updated
Aug 27, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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