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PET-CT After Nellix Implantation

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02349100
Enrollment
10
Registered
2015-01-28
Start date
2015-01-31
Completion date
2016-08-30
Last updated
2017-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Aneurysm, Endovascular Repair

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.

Interventions

DEVICENellix Endoprosthesis

Implantation of Nellix

Sponsors

Rijnstate Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Patients treated with Nellix endoprosthesis

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Difference in physiological FDG uptake following Nellix EVAS implantation in patients without known infections or malignancies as measured by standard uptake values (SUV)1 monthComparing 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).

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026