Visualization of Carotid Atherosclerosis by 68Ga-MSA

Atherosclerosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01893489
• Other study ID #: Ga_MSA_CAD_carotid
• Status: Completed
• Phase: Phase 1
• First received: June 27, 2013
• Last updated: August 23, 2013
• Start date: September 2012
• Est. completion date: August 2013

Study information

• Verified date: August 2013
• Source: Korea University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Atherosclerosis
• Carotid Artery Diseases
• Carotid Atherosclerosis
• Noninvasive Imaging of Atherosclerosis

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Department of Nuclear Medicine, Institute of Radiation Medicine,	Seoul
Korea, Republic of	Korea University Guro Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Korea University	SHIN JIN MEDICS

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	with 2 hours after MSA injection	Yes
Primary	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.	24 hours after MSA injection	Yes
Secondary	standard uptake unit(SUV) at carotid arteries		baseline	No
Secondary	SUV at aorta and iliac arteries		baseline	No