PET-CT After Nellix Implantation

Aortic Aneurysm Clinical Trial

Official title:

Clinical Relevance of Positron Emission Tomography (PET) Imaging Following Endovascular Aneurysm Repair Using the Nellix Endoprosthesis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02349100
• Other study ID #: 1093
• Status: Completed
• Phase: N/A
• First received: January 12, 2015
• Last updated: April 10, 2017
• Start date: January 2015
• Est. completion date: August 30, 2016

Study information

• Verified date: April 2017
• Source: Rijnstate Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: August 30, 2016
• Est. primary completion date: July 13, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients treated with Nellix endoprosthesis

Exclusion Criteria:

• Diabetes Mellitus (Type 1 and type 2)

• Current known inflammation or malignancy

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Endovascular Repair

Intervention

Device:
• Nellix Endoprosthesis
Implantation of Nellix

Locations

Country	Name	City	State
Netherlands	Rijnstate Ziekenhuis	Arnhem	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Rijnstate Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in physiological FDG uptake following Nellix EVAS implantation in patients without known infections or malignancies as measured by standard uptake values (SUV)	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).	1 month