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
  Purpose

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.


Condition Intervention Phase
Atherosclerosis
Carotid Atherosclerosis
Noninvasive Imaging of Atherosclerosis
Other: 68Gallium-MSA
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Korea University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Enrollment: 12
Study Start Date: September 2012
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Atherosclerosis
coronary artery disease patients with carotid plaques confirmed by a ultrasound study
Other: 68Gallium-MSA
68Gallium-MSA 2.0 mci for Positron Emission Tomogram(PET) imaging
Other Name: 68Gallium-MSA
Sham Comparator: control
no coronary artery disease patients without carotid plaques confirmed by a ultrasound study
Other: 68Gallium-MSA
68Gallium-MSA 2.0 mci for Positron Emission Tomogram(PET) imaging
Other Name: 68Gallium-MSA

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01893489

Locations
Korea, Republic of
Korea University Guro Hospital
Seoul, Korea, Republic of, 152-703
Department of Nuclear Medicine, Institute of Radiation Medicine,
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Korea University
SHIN JIN MEDICS
  More Information

No publications provided

Responsible Party: Hong Seog Seo, Professor of Medicine, Korea University
ClinicalTrials.gov Identifier: NCT01893489     History of Changes
Other Study ID Numbers: Ga_MSA_CAD_carotid
Study First Received: June 27, 2013
Last Updated: August 23, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Korea University:
positron emission tomography
macrophage
neomannosyl human serum albumin

Additional relevant MeSH terms:
Atherosclerosis
Coronary Artery Disease
Carotid Artery Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on April 17, 2014