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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04577716
Other study ID # AC20136
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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