Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2026-02-22 @ 2:17 PM
Study NCT ID:
NCT01889693
Status:
COMPLETED
Last Update Posted:
2013-08-27
First Post:
2013-06-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Imaging of Atherosclerosis With 68Ga-MSA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050197', 'term': 'Atherosclerosis'}], 'ancestors': [{'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-23', 'studyFirstSubmitDate': '2013-06-26', 'studyFirstSubmitQcDate': '2013-06-27', 'lastUpdatePostDateStruct': {'date': '2013-08-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'comparison of SUV(standard uptake unit) at atherosclerotic plaque of aorta and carotid arteries among 3 groups', 'timeFrame': '1 day at the time of PET(positron emission tomogram) imaging'}], 'secondaryOutcomes': [{'measure': 'side effect of PET imaging with 68Ga-MSA', 'timeFrame': 'with 7 days after PET imaging', 'description': 'any side effects including changes of biochemical values and vital signs'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['positron emission tomography', 'macrophage', 'neomannosyl human serum albumin'], 'conditions': ['Atherosclerosis', 'Noninvasive Imaging of Atherosclerosis']}, 'descriptionModule': {'briefSummary': 'Despite of intensive efforts, no specific ath¬erosclerosis-targeting agent labeled with positron emitter is not yet available. Fortunately, some scientists made the major advance in the field of clinical atherosclerosis molecular imaging by the metabolic PET reporter agent 18F(fluorine-18)-FDG(Fludeoxyglucose) applied to noninvasively image plaque macrophages in carotid arteries. However, coronary and cerebral arterial segments remain uninterpretable due to metabolic property of 18F-FDG. Applying the character of the terminal mannose residues of MSA binding with the mannose receptors of macrophages in atherosclerosis, we investigate whether 68Ga-MSA can be a novel agent for non-invasive molecular imaging of atherosclerotic lesion in PET.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '20 patients with acute coronary syndrome, 20 patients with chronic stable angina and 20 control subjects wihout coronary artery disease of the Cardiovascular Center at Korea University Guro Hospital', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* acute coronary syndrome(acute myocardial infarction, unstable angina)\n* chronic stable angina\n* control without coronary artery disease\n\nExclusion Criteria:\n\n* pregnancy, allergy to albumin, chronic inflammatory disease'}, 'identificationModule': {'nctId': 'NCT01889693', 'briefTitle': 'Imaging of Atherosclerosis With 68Ga-MSA', 'organization': {'class': 'OTHER', 'fullName': 'Korea University'}, 'officialTitle': 'Identification of Vascular Inflammatory Image Using a 68Ga-MSA(Gallium-68 Neomannosyl Human Serum Albumin) in Patients With Atherosclerotic Lesions', 'orgStudyIdInfo': {'id': 'GaMSA-Atherosclerosis'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'acute coronary syndrome', 'description': 'patients with acute myocardial infarction and unstable angina'}, {'label': 'chronic stable angina', 'description': 'patients with chronic stable angina'}, {'label': 'control', 'description': 'control subjects without coronary artery disease'}]}, 'contactsLocationsModule': {'locations': [{'zip': '152-703', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Korea University Guro Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Korea University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Health & Welfare, Korea', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'Hong Seog Seo', 'investigatorAffiliation': 'Korea University'}}}}