ASAP: PET/CT Imaging of Aneurysm Wall Inflammation

Sponsor

Radboud University Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT00661518

Collaborator

(none)

Enrollment

Location

Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
Aortic Aneurysm

Study Design

Study Type:

Observational

Anticipated Enrollment :

35 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Imaging of Aneurysm Wall Inflammation Using Positron Emission Tomography.

Study Start Date :

Oct 1, 2007

Anticipated Primary Completion Date :

Oct 1, 2008

Anticipated Study Completion Date :

Dec 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
1 Patients scheduled for conventional aneurysm repair
2 Patients scheduled for endovascular aneurysm repair

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Radboud University Nijmegen Medical Centre	Nijmegen	Gelderland	Netherlands	6500HB

Sponsors and Collaborators

Radboud University Medical Center

Investigators

Principal Investigator: Maarten Truijers, MD, Radboud University Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00661518

Other Study ID Numbers:

ASAP

First Posted:

Apr 18, 2008

Last Update Posted:

Apr 18, 2008

Last Verified:

Apr 1, 2008

Additional relevant MeSH terms:

Aneurysm

Aortic Aneurysm

Inflammation

Study Results

No Results Posted as of Apr 18, 2008