PET/CT Imaging of Aneurysm Wall Inflammation

Aortic Aneurysm Clinical Trial

— ASAP  

Official title:

Imaging of Aneurysm Wall Inflammation Using Positron Emission Tomography.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00661518
• Other study ID #: ASAP
• Status: Recruiting
• Phase: N/A
• First received: April 14, 2008
• Last updated: April 14, 2008
• Start date: October 2007
• Est. completion date: December 2008

Study information

• Verified date: April 2008
• Source: Radboud University
• Contact: Maarten Truijers, MD
• Phone: +31243613956
• Email: m.truijers[@]chir.umcn.nl
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: December 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

• Informed consent

Exclusion Criteria:

• Diabetes Mellitus type 1 en 2

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm

Locations

Country	Name	City	State
Netherlands	Radboud University Nijmegen Medical Centre	Nijmegen	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands,