Predicting Endoleaks Following Endovascular Aortic Aneurysm Repair Using 18F-Sodium Fluoride

Abdominal Aortic Aneurysm Clinical Trial

— PET-EVAR  

Official title:

The PET-EVAR Study - Predicting Endoleaks Following Endovascular Aortic Aneurysm Repair Using 18F-Sodium Fluoride

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04577716
• Other study ID #: AC20136
• Status: Active, not recruiting
• Start date: April 1, 2021
• Est. completion date: May 20, 2026

Study information

• Verified date: July 2023
• Source: University of Edinburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 102
• Est. completion date: May 20, 2026
• Est. primary completion date: May 20, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• A diagnosis of AAA as defined by the European Society of Vascular Surgery guidelines on the management of aorto-iliac artery aneurysms, and having undergone endovascular repair within the recommended Instructions For Use (IFU) by the manufacturer. ['Endoleak' and 'No Endoleak groups only]

• Complication will be defined as any type of endoleak or stent graft migration ['Endoleak' group only].

• A diagnosis of AAA requiring endovascular repair OR a diagnosis of juxtarenal AAA requiring fenestrated endovascular aneurysm repair as defined by the European Society of Vascular surgery guidelines on the management of aorto-iliac artery aneurysms and planned EVAR or fenestrated EVAR surgery. ['pre-EVAR' group only]

• Minimum age: 50 years. No maximum age.

• Retain capacity for informed consent

Exclusion Criteria:

• The inability of patients to undergo PET/CT scanning

• Chronic kidney disease (eGFR = 30 mL/min/1.73 m2)

• Major or untreated cancer

• Pregnancy

• Allergy or contra-indication to iodinated contrast

• Inability or unwillingness to give informed consent

• Life-expectancy of less than two years

• Known history of connective tissue disease

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysm
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal
• Endoleak
• Stent-Graft Endoleak

Intervention

Diagnostic Test:
• 18F Sodium Fluoride Positron Emission Tomography / Computed Tomography
PET scan using the 18F-Sodium Fluoride radiotracer followed by an attenuation correction CT scan
• CT Aortic Angiogram
CT scan to assess aortic morphology and contextualise PET scan
• 12-month CT Aortic Angiogram
CT scan to assess aortic morphology and the stent graft

Other:
• 24-month review
This will consist of a telephone consultation with the study participant and review of electronic clinical records

Locations

Country	Name	City	State
United Kingdom	Ninewells Hospital	Dundee
United Kingdom	University Hospital Hairmyres	East Kilbride
United Kingdom	Royal Infirmary of Edinburgh	Edinburgh
United Kingdom	Queen Elizabeth University Hospital	Glasgow

Sponsors (5)

Lead Sponsor	Collaborator
University of Edinburgh	NHS Greater Glasgow and Clyde, NHS Lanarkshire, NHS Lothian, NHS Tayside

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Debono S, Nash J, Fletcher AJ, Syed M, van Beek EJR, Williams MC, Falah O, Tambyraja A, Dweck MR, Newby DE, Forsythe RO. Aortic sodium [18F]fluoride uptake following endovascular aneurysm repair. Heart. 2023 May 10:heartjnl-2023-322514. doi: 10.1136/heart — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Co-localisation of 18F-Sodium Fluoride with histological changes in aortic tissue	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.	12-36 months
Primary	Microcalcification activity in stented and aneurysmal aorta	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.	12 months
Secondary	Pattern of microcalcification activity in the stented aorta	Microcalcification activity	12 months
Secondary	Intensity of microcalcification activity in the stented aorta	Microcalcification activity	12 months
Secondary	Endoleaks	Computed tomography and ultrasound endpoints	12 months
Secondary	Stent graft migration	Computed tomography and ultrasound endpoints	12 months
Secondary	Aneurysm sac diameter	Computed tomography and ultrasound endpoints	12 months
Secondary	Neck diameter and neck angulation	Computed tomography and ultrasound endpoints	12 months
Secondary	Geometry: tortuosity, curvature, torsion	Computed tomography and ultrasound endpoints	12 months
Secondary	Aneurysm-related mortality	Clinical endpoints	24 months
Secondary	Re-intervention	Clinical endpoints	24 months
Secondary	All-cause mortality	Clinical endpoints	24 months