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

June 27, 2013
August 23, 2013
September 2012
August 2013   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01893489 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
  • Atherosclerosis
  • Carotid Atherosclerosis
  • Noninvasive Imaging of Atherosclerosis
Other: 68Gallium-MSA
68Gallium-MSA 2.0 mci for Positron Emission Tomogram(PET) imaging
Other Name: 68Gallium-MSA
  • Active Comparator: Atherosclerosis
    coronary artery disease patients with carotid plaques confirmed by a ultrasound study
    Intervention: Other: 68Gallium-MSA
  • Sham Comparator: control
    no coronary artery disease patients without carotid plaques confirmed by a ultrasound study
    Intervention: Other: 68Gallium-MSA
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
August 2013
August 2013   (final data collection date for primary outcome measure)

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
Both
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01893489
Ga_MSA_CAD_carotid
No
Hong Seog Seo, Korea University
Korea University
SHIN JIN MEDICS
Not Provided
Korea University
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP