Predicting Endoleaks Following Endovascular Aortic Aneurysm Repair Using 18F-Sodium Fluoride (PET-EVAR)

July 21, 2023 updated by: University of Edinburgh

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

102

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
      • Dundee, United Kingdom, DD2 1SG
        • Ninewells Hospital
      • East Kilbride, United Kingdom, G75 8RG
        • University Hospital Hairmyres
      • Edinburgh, United Kingdom, EH16 4SB
        • Royal Infirmary of Edinburgh
      • Glasgow, United Kingdom, G51 4TF
        • Queen Elizabeth University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population will consist of individuals with an abdominal aortic aneurysm (AAA). The first part of the study (Study 1 - Case Control Study) will recruit patients with existing EVAR in to two groups: patients that have an endoleak or related complication (endoleak group, n = 22) and those that have remained complication-free (no endoleak group, n = 22). We will also prospectively recruit patients who are yet to receive EVAR or fenestrated EVAR (pre-EVAR group, n = 100) for the (Study 2 - Cohort Study).

There will be four patient identification centres from which patients will be recruited: NHS Lothian, NHS Lanarkshire, NHS Greater Glasgow and Clyde, and NHS Tayside.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Endoleak Group
Participants with a previous Endovascular Aneurysm Repair (EVAR) who have developed an endoleak
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
Diagnostic test: CT Aortic Angiogram
CT scan to assess aortic morphology and contextualise PET scan
No Endoleak Group
Participants with a previous Endovascular Aneurysm Repair (EVAR) who have not developed an endoleak
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
Diagnostic test: CT Aortic Angiogram
CT scan to assess aortic morphology and contextualise PET scan
Pre-EVAR Group
Participants who have an abdominal aortic aneurysm and who are undergoing an Endovascular Aneurysm Repair as standard of care
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
Diagnostic test: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Microcalcification activity in stented and aneurysmal aorta
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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pattern of microcalcification activity in the stented aorta
Time Frame: 12 months
Microcalcification activity
12 months
Intensity of microcalcification activity in the stented aorta
Time Frame: 12 months
Microcalcification activity
12 months
Endoleaks
Time Frame: 12 months
Computed tomography and ultrasound endpoints
12 months
Stent graft migration
Time Frame: 12 months
Computed tomography and ultrasound endpoints
12 months
Aneurysm sac diameter
Time Frame: 12 months
Computed tomography and ultrasound endpoints
12 months
Neck diameter and neck angulation
Time Frame: 12 months
Computed tomography and ultrasound endpoints
12 months
Geometry: tortuosity, curvature, torsion
Time Frame: 12 months
Computed tomography and ultrasound endpoints
12 months
Aneurysm-related mortality
Time Frame: 24 months
Clinical endpoints
24 months
Re-intervention
Time Frame: 24 months
Clinical endpoints
24 months
All-cause mortality
Time Frame: 24 months
Clinical endpoints
24 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Co-localisation of 18F-Sodium Fluoride with histological changes in aortic tissue
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.
12-36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Edinburgh

Collaborators

NHS Lothian
NHS Tayside
NHS Greater Glasgow and Clyde
NHS Lanarkshire

Investigators

  • Principal Investigator: Samuel Debono, University of Edinburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2021

Primary Completion (Estimated)

May 20, 2025

Study Completion (Estimated)

May 20, 2026

Study Registration Dates

First Submitted

September 16, 2020

First Submitted That Met QC Criteria

September 30, 2020

First Posted (Actual)

October 8, 2020

Study Record Updates

Last Update Posted (Actual)

July 25, 2023

Last Update Submitted That Met QC Criteria

July 21, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AC20136

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There are no plans for individual participant data sharing.

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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