Visualization of Carotid Atherosclerosis by 68Ga-MSA

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01893489

Enrollment

Registered

2013-07-09

Start date

2012-09-30

Completion date

2013-08-31

Last updated

2013-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerosis, Carotid Atherosclerosis, Noninvasive Imaging of Atherosclerosis

Keywords

positron emission tomography, macrophage, neomannosyl human serum albumin

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.

Interventions

OTHER68Gallium-MSA

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
side reactions at MSA injection site of the skin	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
unstable changes of vital signs and development of abnormal biochemical parameters	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

Measure	Time frame
standard uptake unit(SUV) at carotid arteries	baseline
SUV at aorta and iliac arteries	baseline

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026