- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00661518
PET/CT Imaging of Aneurysm Wall Inflammation (ASAP)
Imaging of Aneurysm Wall Inflammation Using Positron Emission Tomography.
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.
Studieoversikt
Status
Forhold
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiesteder
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Gelderland
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Nijmegen, Gelderland, Nederland, 6500HB
- Rekruttering
- Radboud University Nijmegen Medical Centre
-
Ta kontakt med:
- Maarten Truijers, MD
- Telefonnummer: +31243613956
- E-post: M.truijers@chir.umcn.nl
-
Hovedetterforsker:
- Maarten Truijers, MD
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
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
Beskrivelse
Inclusion Criteria:
- scheduled for conventional (10 patients) or endovascular (25 patients) aneurysm repair.
- Informed consent
Exclusion Criteria:
- Diabetes Mellitus type 1 en 2
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
---|
1
Patients scheduled for conventional aneurysm repair
|
2
Patients scheduled for endovascular aneurysm repair
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Maarten Truijers, MD, Radboud University Medical Center
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ASAP
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