PET-CT After Nellix Implantation

Completed

• Conditions: Aortic Aneurysm; Endovascular Repair

• Registration Number: NCT02349100
• Lead Sponsor: Rijnstate Hospital

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.

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-01-12
• Study First Submitted QC: 2015-01-22
• Study First Posted: 2015-01-28
• Primary Completion: 2016-07-13
• Study Completion: 2016-08-30
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-10
• Last Update Posted: 2017-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Patients treated with Nellix endoprosthesis

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference in physiological FDG uptake following Nellix EVAS implantation in patients without known infections or malignancies as measured by standard uptake values (SUV)	1 month	Comparing pre- and post-implantation FDG uptake with ROI set at the aneurysm and stent. Measured SUV from FDG emission will be compared and subtracted and the difference will be reported (in MBq/kg).

Trial Locations

Locations (1)

Rijnstate Ziekenhuis; 🇳🇱 Arnhem, Gelderland, Netherlands