Visualization of Carotid Atherosclerosis by 68Ga-MSA

Condition(s) targeted: Atherosclerosis; Carotid Atherosclerosis; Noninvasive Imaging of Atherosclerosis

Intervention: 68Gallium-MSA (Other)

Phase: Phase 1

Status: Completed

Sponsored by: Korea University

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.

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

Primary outcome:

side reactions at MSA injection site of the skin

unstable changes of vital signs and development of abnormal biochemical parameters

Secondary outcome:

standard uptake unit(SUV) at carotid arteries

SUV at aorta and iliac arteries

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

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

Department of Nuclear Medicine, Institute of Radiation Medicine,, Seoul 110-744, Korea, Republic of

Korea University Guro Hospital, Seoul 152-703, Korea, Republic of

Starting date: September 2012
Last updated: August 23, 2013