PET/CT Imaging of Aneurysm Wall Inflammation (ASAP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00661518
Recruitment Status : Unknown
Verified April 2008 by Radboud University.
Recruitment status was:  Recruiting
First Posted : April 18, 2008
Last Update Posted : April 18, 2008
Information provided by:
Radboud University

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.

Condition or disease
Aortic Aneurysm

Study Type : Observational
Estimated Enrollment : 35 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Imaging of Aneurysm Wall Inflammation Using Positron Emission Tomography.
Study Start Date : October 2007
Estimated Primary Completion Date : October 2008
Estimated Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms

Patients scheduled for conventional aneurysm repair
Patients scheduled for endovascular aneurysm repair

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Inclusion Criteria:

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

Exclusion Criteria:

  • Diabetes Mellitus type 1 en 2

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00661518

Contact: Maarten Truijers, MD +31243613956

Radboud University Nijmegen Medical Centre Recruiting
Nijmegen, Gelderland, Netherlands, 6500HB
Contact: Maarten Truijers, MD    +31243613956   
Principal Investigator: Maarten Truijers, MD         
Sponsors and Collaborators
Radboud University
Principal Investigator: Maarten Truijers, MD Radboud University

Responsible Party: M. Truijers, MD, Radboud University Nijmegen Medical Centre Identifier: NCT00661518     History of Changes
Other Study ID Numbers: ASAP
First Posted: April 18, 2008    Key Record Dates
Last Update Posted: April 18, 2008
Last Verified: April 2008

Additional relevant MeSH terms:
Aortic Aneurysm
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases