Clinical trial NCT02349100: PET-CT After Nellix Implantation
Official title: Clinical Relevance of Positron Emission Tomography (PET) Imaging Following Endovascular Aneurysm Repair Using the Nellix Endoprosthesis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Aneurysm
Endovascular Repair
Lead sponsor: Rijnstate Hospital
Sponsor class: OTHER
First posted: 2015-01-28
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with abdominal aortic aneurysms eligible for EVAS with Nellix endoprosthesis.

Brief summary: To determine FDG uptake following uncomplicated EVAR using the Nellix endoprosthesis. Does uncomplicated EVAR using the nellix endoprosthesis result in increased FDG uptake and false positive PET imaging?

Detailed description: One of the most devastating complications following endovascular aneurysm repair (EVAR) is infection of the used endoprosthesis. Because of the high mortality of secondary surgery following infection, patients with a possible endoprosthesis infection are treated using broadspectrum antibiotics during months, years or even life-long. Unfortunately, the diagnosis of an endoprosthesis infection is difficult and based upon clinical suspicion and non-specific symptoms (e.g. fever and weigth loss) only. Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) is often used as a diagnostic tool to identify infection following EVAR. Like infection, sterile physiologic inflammation following EVAR is also associated with increased metabolism and FDG uptake. This could result in (false-)positive PET imaging resulting in diagnostic errors and antibiotic overuse.

The Nellix endoprosthesis is a relatively new device used for EVAR. In present literature there is no data on the degree of physiologic inflammation following implantation of a Nellix device and the value of postoperative FDG-PET imaging to detect infection is not known. This makes the diagnosis of infection following Nellix implantation extremely difficult. This pilot is designed to determine physiologic FDG uptake following uncomplicated EVAR using the Nellix endoprosthesis.

Eligibility criteria: Inclusion Criteria:

* Patients treated with Nellix endoprosthesis

Exclusion Criteria:

* Diabetes Mellitus (Type 1 and type 2)
* Current known inflammation or malignancy

Primary outcomes:
measure: Difference in physiological FDG uptake following Nellix EVAS implantation in patients without known infections or malignancies as measured by standard uptake values (SUV)
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Arnhem
country: Netherlands
facility: Rijnstate Ziekenhuis
state: Gelderland
Study officials:
affiliation: Rijnstate Hospital
name: Michel Reijnen, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Groot Jebbink E, van Den Ham LH, van Woudenberg BBJ, Slart RHJA, Zeebregts CJ, Rijnders TJM, Lardenoije JHP, Reijnen MMPJ. Physiological Appearance of Hybrid FDG-Positron Emission Tomography/Computed Tomography Imaging Following Uncomplicated Endovascular Aneurysm Sealing Using the Nellix Endoprosthesis. J Endovasc Ther. 2020 Jun;27(3):509-515. doi: 10.1177/1526602820913888. Epub 2020 Apr 15.