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

NCT04577716 | Completed

• 1 other identifier: AC20136
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Abdominal Aortic Aneurysm; Endoleak; Stent-Graft Endoleak

Keywords

EVAR; Endoleak; 18F-Sodium Fluoride; PET

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Pattern of microcalcification activity in the stented aorta

  12 months

• Intensity of microcalcification activity in the stented aorta

  12 months

• Endoleaks

  12 months

• Stent graft migration

  12 months

• Aneurysm sac diameter

  12 months

Other Outcomes (1)

• Co-localisation of 18F-Sodium Fluoride with histological changes in aortic tissue

  12-36 months

Study Arms (3)

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; Diagnostic Test: CT Aortic Angiogram

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; Diagnostic Test: CT Aortic Angiogram

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; Diagnostic Test: 12-month CT Aortic Angiogram; Other: 24-month review

Interventions

18F Sodium Fluoride Positron Emission Tomography / Computed Tomography DIAGNOSTIC_TEST

PET scan using the 18F-Sodium Fluoride radiotracer followed by an attenuation correction CT scan

Endoleak Group; No Endoleak Group; Pre-EVAR Group

CT Aortic Angiogram DIAGNOSTIC_TEST

CT scan to assess aortic morphology and contextualise PET scan

Endoleak Group; No Endoleak Group

12-month CT Aortic Angiogram DIAGNOSTIC_TEST

CT scan to assess aortic morphology and the stent graft

Pre-EVAR Group

24-month review OTHER

This will consist of a telephone consultation with the study participant and review of electronic clinical records

Pre-EVAR Group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Edinburgh: lead
• NHS Lothian: collaborator
• NHS Greater Glasgow and Clyde: collaborator
• NHS Lanarkshire: collaborator
• NHS Tayside: collaborator

Study Sites (4)

Ninewells Hospital

Dundee, DD2 1SG, United Kingdom

Location

University Hospital Hairmyres

East Kilbride, G75 8RG, United Kingdom

Location

Royal Infirmary of Edinburgh

Edinburgh, EH16 4SB, United Kingdom

Location

Queen Elizabeth University Hospital

Glasgow, G51 4TF, United Kingdom

Location

Related Publications (2)

• 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 Oct 26;109(22):1677-1682. doi: 10.1136/heartjnl-2023-322514.

  PMID: 37164479 RESULT

• Debono S, Nash J, Tambyraja AL, Newby DE, Forsythe RO. Endovascular repair for abdominal aortic aneurysms. Heart. 2021 Nov;107(22):1783-1789. doi: 10.1136/heartjnl-2020-318288. Epub 2021 Mar 4.

  PMID: 33674354 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Aortic tissue specimens obtained from individuals undergoing open surgical repair will be studied histologically, using autoradiography and micro-PET/CT.

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal; Endoleak

Interventions

Tomography, X-Ray Computed

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Postoperative Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography

Study Officials

• Samuel Debono

  University of Edinburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2020
• First Posted: October 8, 2020
• Study Start: April 1, 2021
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: July 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (4)