PET/CT Imaging of Aneurysm Wall Inflammation (ASAP)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2008 by Radboud University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00661518
First received: April 14, 2008
Last updated: NA
Last verified: April 2008
History: No changes posted

April 14, 2008
April 14, 2008
October 2007
October 2008   (final data collection date for primary outcome measure)
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No Changes Posted
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PET/CT Imaging of Aneurysm Wall Inflammation
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.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample

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

Aortic Aneurysm
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  • 1
    Patients scheduled for conventional aneurysm repair
  • 2
    Patients scheduled for endovascular aneurysm repair
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
35
December 2008
October 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • scheduled for conventional (10 patients) or endovascular (25 patients) aneurysm repair.
  • Informed consent

Exclusion Criteria:

  • Diabetes Mellitus type 1 en 2
Both
Not Provided
No
Contact: Maarten Truijers, MD +31243613956 m.truijers@chir.umcn.nl
Netherlands
 
NCT00661518
ASAP
No
M. Truijers, MD, Radboud University Nijmegen Medical Centre
Radboud University
Not Provided
Principal Investigator: Maarten Truijers, MD Radboud University
Radboud University
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP