Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2025-12-29 @ 6:46 PM
Study NCT ID:
NCT02229006
Status:
COMPLETED
Last Update Posted:
2017-05-17
First Post:
2014-08-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sodium Fluoride Imaging of Abdominal Aortic Aneurysms
Sponsor:
University of Edinburgh
Organization:
Study Overview
Official Title:
SoFIA3: Sodium Fluoride Imaging (18F-NaF PET-CT) in Abdominal Aortic Aneurysms
Status:
COMPLETED
Status Verified Date:
2016-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SoFIA3
Brief Summary:
The purpose of this study is to determine whether Sodium Fluoride imaging (using Positron Emission Tomography-Computed Tomography - PET-CT) is able to help predict the rate of abdominal aortic aneurysm expansion.
Detailed Description:
Ruptured abdominal aortic aneurysms (AAAs) have a 90% mortality rate but there are currently no accurate methods of establishing the risk of rupture for an individual patient with an asymptomatic AAA. In vascular disease, microcalcification occurs in response to necrotic inflammation. Using computed tomography and positron emission tomography (PET-CT), early micro calcification 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. The study investigators therefore propose to evaluate the ability of 18F-sodium fluoride to identify regions of necrotic inflammation in AAA and predict AAA expansion. The study investigators will explore its value as part of an ongoing clinical trial assessing the identification of macrophage activity using magnetic resonance imaging - the MA3RS Study (ISRCTN76413758). Patients already enrolled in the MA3RS Study will be recruited for the SoFIA3 study. Control patients with a normal calibre aorta will be recruited from the National AAA Screening Programme.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: