PET/CT Imaging of Aneurysm Wall Inflammation (ASAP)

R

Radboud University Medical Center

Status

Unknown

Conditions

Aortic Aneurysm

Study type

Observational

Funder types

Other

Identifiers

NCT00661518
ASAP

Details and patient eligibility

About

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.

Enrollment

35 estimated patients

Sex

All

Volunteers

No 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

Trial design

35 participants in 2 patient groups

1
Description:
Patients scheduled for conventional aneurysm repair
2
Description:
Patients scheduled for endovascular aneurysm repair

Trial contacts and locations

0

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Central trial contact

Maarten Truijers, MD

Data sourced from clinicaltrials.gov

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