Aortic AneurysmNCT02349100
PET-CT After Nellix Implantation
An observational study of Aortic Aneurysm and Endovascular Repair, run by Rijnstate Hospital at 1 site in Netherlands.
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? Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Aneurysm, Endovascular Repair
- What is being tested?
- Nellix Endoprosthesis
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2015to 30 Aug 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with abdominal aortic aneurysms eligible for EVAS with Nellix endoprosthesis.
Who may be able to join
- Patients treated with Nellix endoprosthesis
Who cannot join
- Diabetes Mellitus (Type 1 and type 2)
- Current known inflammation or malignancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Relevance of Positron Emission Tomography (PET) Imaging Following Endovascular Aneurysm Repair Using the Nellix Endoprosthesis
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?
Read the 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.
- Conditions
- Aortic Aneurysm, Endovascular Repair
- Being tested
- Nellix Endoprosthesis
- Medical subject headings
- Aortic Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nellix EndoprosthesisDevice
Implantation of Nellix
| Study group | Role | What they receive |
|---|---|---|
| Treated group | Patient group treated with Nellix Endoprosthesis. Receives: Device: Nellix Endoprosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2015 (estimated)
- Study startJan 2015
- Primary completion13 Jul 2016
- Study completion30 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aortic AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michel Reijnen, Rijnstate Hospital
- Investigators
- Michel Reijnen, PhD, MD, Principal investigator, Rijnstate Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02349100
- Sponsor's protocol ID
- 1093
- Status last verified
- Apr 2017
- First submitted
- 12 Jan 2015
- Last updated
- 11 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 32295455
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Relevance of Positron Emission Tomography (PET) Imaging Following Endovascular Aneurysm Repair Using the Nellix Endoprosthesis
- ClinicalTrials.gov ID
- NCT02349100
- Acronym / sponsor ID
- 1093
- Conditions
- Aortic Aneurysm, Endovascular Repair
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- 13 Jul 2016 (actual)
- Study completion
- 30 Aug 2016 (actual)
- First posted
- 28 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treated group | – | Device: Nellix EndoprosthesisPatient group treated with Nellix Endoprosthesis. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with abdominal aortic aneurysms eligible for EVAS with Nellix endoprosthesis.
Key inclusion criteria (1 listed)
- Patients treated with Nellix endoprosthesis
Key exclusion criteria (2 listed)
- Diabetes Mellitus (Type 1 and type 2)
- Current known inflammation or malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nellix EndoprosthesisImplantation of Nellix | Device | Treated group |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2017.
- Derived from this study: PubMed 32295455Groot 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michel Reijnen, PhD, MD principal investigator
Rijnstate Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Aneurysm and Endovascular Repair, run by Rijnstate Hospital at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02349100, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2017.