NCT03647566

18F Sodium Fluoride PET/CT in Acute Aortic Syndrome

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 76 (actual)
• Sponsor: University of Edinburgh · Academic / Other
• Sex: All
• Age: 25 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine whether Sodium Fluoride imaging (using Positron Emission Tomography-Computed Tomography - PET-CT) is able to predict disease progression in acute aortic syndrome.

Detailed description

Acute Aortic Syndrome encompasses multiple aortopathies, including aortic dissection, intramural haematoma and penetrating aortic ulcers. Acute aortic syndrome has a three year mortality approaching 25%. To date, other than the initial aortic diameter, there are no accurate methods of establishing the risk of disease progression in patients with acute aortic syndrome. In vascular disease, microcalcification occurs in response to necrotic inflammation. Using computed tomography and positron emission tomography (PET-CT), early microcalcification can be identified using uptake of the radiotracer 18F-sodium fluoride. This can identify high risk-lesions in the aorta, coronary and carotid arteries, and appears to be indicative of necrotic and heavily inflamed tissue. In abdominal aortic aneurysms, 18F-sodium fluoride binding predicts aortic expansion and the risk of aneurysm rupture or requirement for surgical repair. The study investigators, therefore, propose to evaluate the ability of 18F-sodium fluoride to identify regions of necrotic inflammation in acute aortic syndrome to predict aortic expansion and disease progression. Control patients with a normal calibre aorta will be recruited from the National Abdominal Aortic Aneurysm Screening Programme and Vascular Out-Patient Clinics. Patients with acute aortic syndrome and chronic aortic disease will undergo clinical assessments and 18F Sodium Fluoride PET/CT scans at baseline and 12-months. Clinical follow-up will continue for up to 3 years from recruitment.

Conditions

• Acute Aortic Syndrome
• Aortic Dissection
• Penetrating Aortic Ulcer
• Intramural Hematoma

Interventions

Type	Name	Description
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
DIAGNOSTIC_TEST	Aortic MRI	Aortic MRI to assess aortic morphology and contextualise PET scan

Timeline

• Start date: 2018-10-01
• Primary completion: 2021-02-01
• Completion: 2021-02-01
• First posted: 2018-08-27
• Last updated: 2022-03-14

Locations

1 site across 1 country: United Kingdom