Brief Title
Sodium Fluoride Imaging of Abdominal Aortic Aneurysms
Official Title
SoFIA3: Sodium Fluoride Imaging (18F-NaF PET-CT) in Abdominal Aortic Aneurysms
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 Type
Observational
Primary Outcome
Change in abdominal aortic aneurysm anteroposterior diameter over time at 6 and 12 months (mm)
Secondary Outcome
Co-localisation of 18F-NaF with USPIO uptake on MRI scanning
Condition
Abdominal Aortic Aneurysm
Intervention
18F-NaF PET-CT
Study Arms / Comparison Groups
Aneurysm surveillance
Description: Radiation: 18F-NaF PET-CT
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Radiation
Estimated Enrollment
96
Start Date
September 2014
Completion Date
February 2017
Primary Completion Date
January 2017
Eligibility Criteria
Inclusion Criteria (AAA patients): - Patients already enrolled in the MA3RS study (ISRCTN76413758) - Patients with abdominal aortic aneurysm with AP diameter >40 mm on ultrasound - >50 years of age Inclusion Criteria (control patients): - Patients with abdominal aorta with AP diameter <30 mm on ultrasound - >50 years of age Exclusion Criteria: - Patients expected to undergo imminent AAA repair - Patients who refuse or are unable to give informed consent - Women of child-bearing potential without contraception - Patients who are unable to undergo PET-CT scan - Patients with collagen vascular disease - Intercurrent illness, malignancy or comorbidity with life expectancy <1 year - Renal dysfunction (eGFR <30ml/min/1.73m2) - Contraindication to PET-CT or CTA - Iodine allergy
Gender
All
Ages
50 Years - N/A
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Rachael O Forsythe, MD, ,
Location Countries
United Kingdom
Location Countries
United Kingdom
Administrative Informations
NCT ID
NCT02229006
Organization ID
ETM/365
Responsible Party
Sponsor
Study Sponsor
University of Edinburgh
Collaborators
Chief Scientist Office of the Scottish Government
Study Sponsor
Rachael O Forsythe, MD, Principal Investigator, University of Edinburgh
Verification Date
October 2016