18F Sodium Fluoride Positron Emission Tomography / Computed Tomography
Diagnostic TestPET scan using the 18F-Sodium Fluoride radiotracer followed by an attenuation correction CT scan
NCT Number: NCT04577716
The purpose of the study is to describe Sodium Fluoride uptake (using Positron Emission Tomography-Computed Tomography - PET-CT) following Endovascular Aneurysm Repair (EVAR) and to determine whether Sodium Fluoride PET-CT can predict the development of endoleaks.
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Notify Me50 year and older
All sexes
Observational
Ninewells Hospital, Dundee, United Kingdom
Abdominal aortic aneurysms are a leading cause of death in the United Kingdom. Surveillance programmes and pre-emptive surgical repair are lifesaving. Traditional open surgical repair is associated with major perioperative morbidity and mortality and there has been a move towards minimally invasive Endovascular Aneurysm Repair (EVAR), which reduces these early risks. However, the cost effectiveness and long-term clinical effectiveness of EVAR is undermined by concerns of durability due to the development of endoleaks and late aneurysm rupture secondary to progression of native aortic aneurysm disease and stent graft failure. It has previously been demonstrated that 18F-Sodium Fluoride Positron Emission Tomography can predict progression of aneurysm disease and is associated with greater rates of abdominal aortic aneurysm expansion and the future risk of rupture or surgical repair.
The investigators here wish to examine whether 18F-Sodium Fluoride on Positron Emission Tomography uptake (i) is increased in patients with endoleaks or related complications, (ii) can prospectively predict the likelihood of developing endoleaks in patients undergoing EVAR, and (ii) is a feasible approach to select patients for EVAR with a reduced future risk of stent graft failure and re-intervention. The investigators believe that there is a compelling scientific rationale for this approach with major translational potential to better select subgroups of patients for EVAR and ultimately improve their outcome.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
PET scan using the 18F-Sodium Fluoride radiotracer followed by an attenuation correction CT scan
CT scan to assess aortic morphology and contextualise PET scan
CT scan to assess aortic morphology and the stent graft
This will consist of a telephone consultation with the study participant and review of electronic clinical records
Time frame: 12 months
Will be measured as 18F Sodium Fluoride binding in the aorta. Uptake will be quantified in Standardised Uptake Values and as a tissue to background ratios.
Time frame: 12 months
Microcalcification activity
Time frame: 12 months
Microcalcification activity
Time frame: 12 months
Computed tomography and ultrasound endpoints
Time frame: 12 months
Computed tomography and ultrasound endpoints
Time frame: 12 months
Computed tomography and ultrasound endpoints
Time frame: 12 months
Computed tomography and ultrasound endpoints
Time frame: 12 months
Computed tomography and ultrasound endpoints
Time frame: 24 months
Clinical endpoints
Time frame: 24 months
Clinical endpoints
Time frame: 24 months
Clinical endpoints
Time frame: 12-36 months
Uptake of 18F-Sodium Fluoride will be identified on PET-CT scans that are acquired as part of the study visit. This will be compared with histological changes in aortic specimens obtained if participant undergoes an open aortic procedure during the study period.
University of Edinburgh
Other
The PET-EVAR Study - Predicting Endoleaks Following Endovascular Aortic Aneurysm Repair Using 18F-Sodium Fluoride
Acronym: PET-EVAR
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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