- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02349100
PET-CT After Nellix Implantation
Clinical Relevance of Positron Emission Tomography (PET) Imaging Following Endovascular Aneurysm Repair Using the Nellix Endoprosthesis
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Gelderland
-
Arnhem, Gelderland, Netherlands, 6815AD
- Rijnstate Ziekenhuis
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients treated with Nellix endoprosthesis
Exclusion Criteria:
- Diabetes Mellitus (Type 1 and type 2)
- Current known inflammation or malignancy
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Treated group
Patient group treated with Nellix Endoprosthesis.
|
Implantation of Nellix
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference in physiological FDG uptake following Nellix EVAS implantation in patients without known infections or malignancies as measured by standard uptake values (SUV)
Time Frame: 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).
|
1 month
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Michel Reijnen, PhD, MD, Rijnstate Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1093
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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