PET/CT Imaging of Aneurysm Wall Inflammation (ASAP)
Recruitment status was Recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | April 14, 2008 | ||||
| Last Updated Date | April 14, 2008 | ||||
| Start Date ICMJE | October 2007 | ||||
| Estimated Primary Completion Date | October 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | PET/CT Imaging of Aneurysm Wall Inflammation | ||||
| Official Title ICMJE | Imaging of Aneurysm Wall Inflammation Using Positron Emission Tomography. | ||||
| Brief Summary | 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. Objective: 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). Study design: Observational case series (pilot). Study population: Patients scheduled for conventional (open) and endovascular aneurysm repair. Main study parameters: Standard uptake value (SUV) measurements to asses FDG uptake in the aneurysm wall and in vitro aneurysm wall strength (N/mm). Nature and extent of the burden and risks associated with participation, benefit 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | 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. Inclusion criteria Exclusion criteria -Diabetes Mellitus type 1 en 2 |
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| Condition ICMJE | Aortic Aneurysm | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 35 | ||||
| Estimated Completion Date | December 2008 | ||||
| Estimated Primary Completion Date | October 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Netherlands | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00661518 | ||||
| Other Study ID Numbers ICMJE | ASAP | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | M. Truijers, MD, Radboud University Nijmegen Medical Centre | ||||
| Study Sponsor ICMJE | Radboud University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Radboud University | ||||
| Verification Date | April 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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