Ignite Creation Date:
2025-12-25 @ 4:51 AM
Ignite Modification Date:
2025-12-26 @ 3:52 AM
Study NCT ID:
NCT00661518
Status:
UNKNOWN
Last Update Posted:
2008-04-18
First Post:
2008-04-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PET/CT Imaging of Aneurysm Wall Inflammation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001014', 'term': 'Aortic Aneurysm'}], 'ancestors': [{'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001018', 'term': 'Aortic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 35}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-04', 'completionDateStruct': {'date': '2008-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2008-04-14', 'studyFirstSubmitDate': '2008-04-14', 'studyFirstSubmitQcDate': '2008-04-14', 'lastUpdatePostDateStruct': {'date': '2008-04-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-10', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Aortic Aneurysm']}, 'descriptionModule': {'briefSummary': 'Rationale: Aneurysm development, progression and rupture are characterised by extensive inflammation, dominated by the infiltration of T-cells, B-cells and macrophages. Recent studies into the pathophysiology of aneurysm wall degradation suggest a close relation between increased mechanical stress and the local activation of infiltrated lymphocytes and macrophages. The non-invasive detection of aneurysm wall inflammation, using 18-fluorodeoxyglucose positron emission tomography (FDG-PET) might therefore provide valuable information on the extend of the disease and could clarify the role of mechanical stress on the propagation of aneurysm wall inflammation.\n\nObjective: Correlation of FDG uptake and in vitro aneurysm wall tensile strength. (primary objective). The effect of aneurysm sac depressurisation, after endovascular aneurysm repair, on aneurysm wall inflammation (secondary objective).\n\nStudy design: Observational case series (pilot). Study population: Patients scheduled for conventional (open) and endovascular aneurysm repair.\n\nMain study parameters: Standard uptake value (SUV) measurements to asses FDG uptake in the aneurysm wall and in vitro aneurysm wall strength (N/mm).\n\nNature and extent of the burden and risks associated with participation,\n\nbenefit and group relatedness: Patients scheduled for conventional (open) or endovascular aneurysm repair are admitted to the hospital the day before surgery. At that point all patients will be evaluated using FDG-PET. Although intake of sugar-free liquids is permitted, glucose intake is restricted 6 hours prior to FDG-PET imaging. One hour after intravenous injection of 200-220 MBq FDG, whole body emission and transmission images will be acquired. To determine inflammation markers ( e.g. CRP), blood and urine samples will be collected prior to the operation and again 6 weeks after surgery. For in vitro aneurysm wall tensile strength testing wall specimens will be harvested during conventional aneurysm repair.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Population: At the Radboud University Nijmegen Medical Centre, approximately 80 patients undergo prophylactic aneurysm repair each year. 10-15 patients are scheduled for conventional ('open') repair the remaining 65-70 patients undergo endovascular aneurysm. We therefore expect to finish including patients for both studies by the end of august 2008. The study population will be comprised both male (± 80%) and female patients with an abdominal aortic aneurysm.\n\nInclusion criteria\n\nExclusion criteria\n\n-Diabetes Mellitus type 1 en 2", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* scheduled for conventional (10 patients) or endovascular (25 patients) aneurysm repair.\n* Informed consent\n\nExclusion Criteria:\n\n* Diabetes Mellitus type 1 en 2'}, 'identificationModule': {'nctId': 'NCT00661518', 'acronym': 'ASAP', 'briefTitle': 'PET/CT Imaging of Aneurysm Wall Inflammation', 'organization': {'class': 'OTHER', 'fullName': 'Radboud University Medical Center'}, 'officialTitle': 'Imaging of Aneurysm Wall Inflammation Using Positron Emission Tomography.', 'orgStudyIdInfo': {'id': 'ASAP'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Patients scheduled for conventional aneurysm repair'}, {'label': '2', 'description': 'Patients scheduled for endovascular aneurysm repair'}]}, 'contactsLocationsModule': {'locations': [{'zip': '6500HB', 'city': 'Nijmegen', 'state': 'Gelderland', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Maarten Truijers, MD', 'role': 'CONTACT', 'email': 'M.truijers@chir.umcn.nl', 'phone': '+31243613956'}, {'name': 'Maarten Truijers, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Radboud University Nijmegen Medical Centre', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}], 'centralContacts': [{'name': 'Maarten Truijers, MD', 'role': 'CONTACT', 'email': 'm.truijers@chir.umcn.nl', 'phone': '+31243613956'}], 'overallOfficials': [{'name': 'Maarten Truijers, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Radboud University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Radboud University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'M. Truijers, MD', 'oldOrganization': 'Radboud University Nijmegen Medical Centre'}}}}