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
  Purpose

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
Aortic Aneurysm

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Imaging of Aneurysm Wall Inflammation Using Positron Emission Tomography.

Resource links provided by NLM:


Further study details as provided by Radboud University:

Estimated Enrollment: 35
Study Start Date: October 2007
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Patients scheduled for conventional aneurysm repair
2
Patients scheduled for endovascular aneurysm repair

  Eligibility

Genders Eligible for Study:   Both
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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Diabetes Mellitus type 1 en 2
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00661518

Contacts
Contact: Maarten Truijers, MD +31243613956 m.truijers@chir.umcn.nl

Locations
Netherlands
Radboud University Nijmegen Medical Centre Recruiting
Nijmegen, Gelderland, Netherlands, 6500HB
Contact: Maarten Truijers, MD    +31243613956    M.truijers@chir.umcn.nl   
Principal Investigator: Maarten Truijers, MD         
Sponsors and Collaborators
Radboud University
Investigators
Principal Investigator: Maarten Truijers, MD Radboud University
  More Information

No publications provided

Responsible Party: M. Truijers, MD, Radboud University Nijmegen Medical Centre
ClinicalTrials.gov Identifier: NCT00661518     History of Changes
Other Study ID Numbers: ASAP
Study First Received: April 14, 2008
Last Updated: April 14, 2008
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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

ClinicalTrials.gov processed this record on July 20, 2014