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Visualization of Carotid Atherosclerosis by 68Ga-MSA

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01893489
Recruitment Status : Completed
First Posted : July 9, 2013
Last Update Posted : August 27, 2013
Sponsor:
Collaborator:
SHIN JIN MEDICS
Information provided by (Responsible Party):
Hong Seog Seo, Korea University

Tracking Information
First Submitted Date  ICMJE June 27, 2013
First Posted Date  ICMJE July 9, 2013
Last Update Posted Date August 27, 2013
Study Start Date  ICMJE September 2012
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 2, 2013)
  • 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
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01893489 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 2, 2013)
  • standard uptake unit(SUV) at carotid arteries [ Time Frame: baseline ]
  • SUV at aorta and iliac arteries [ Time Frame: baseline ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Visualization of Carotid Atherosclerosis by 68Ga-MSA
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Atherosclerosis
  • Carotid Atherosclerosis
  • Noninvasive Imaging of Atherosclerosis
Intervention  ICMJE Other: 68Gallium-MSA
68Gallium-MSA 2.0 mci for Positron Emission Tomogram(PET) imaging
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 2, 2013)
12
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2013
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01893489
Other Study ID Numbers  ICMJE Ga_MSA_CAD_carotid
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hong Seog Seo, Korea University
Study Sponsor  ICMJE Korea University
Collaborators  ICMJE SHIN JIN MEDICS
Investigators  ICMJE Not Provided
PRS Account Korea University
Verification Date August 2013

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