Clinical trial NCT02229006: Sodium Fluoride Imaging of Abdominal Aortic Aneurysms
Official title: SoFIA3: Sodium Fluoride Imaging (18F-NaF PET-CT) in Abdominal Aortic Aneurysms
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Abdominal Aortic Aneurysm
Keywords: Aortic aneurysm, abdominal
Sodium Fluoride
Positron Emission Tomography
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
Collaborators: name: Chief Scientist Office of the Scottish Government
First posted: 2014-08-29
Enrollment: 96
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Case: patients with abdominal aortic aneurysm enrolled in the hospital ultrasound surveillance programme Control: patients with normal calibre aorta as demonstrated from an ultrasound performed as part of the National AAA Screening Programme

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.

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

Primary outcomes:
measure: Change in abdominal aortic aneurysm anteroposterior diameter over time at 6 and 12 months (mm)
timeFrame: 0, 6, 12 months
Secondary outcomes:
measure: Co-localisation of 18F-NaF with USPIO uptake on MRI scanning
timeFrame: At baseline
Other outcomes:
measure: Co-localisation of 18F-NaF with histological evidence of active calcification, necrotic inflammation and proteolytic degradation of the aneurysm wall
timeFrame: At baseline
measure: Relationship with areas of high wall stress (finite element analysis)
timeFrame: At baseline
measure: Comparison of 18F-NaF uptake in patients with AAA versus control patients
timeFrame: At baseline
Locations:
city: Edinburgh
country: United Kingdom
facility: Royal Infirmary of Edinburgh
Study officials:
affiliation: University of Edinburgh
name: Rachael O Forsythe, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Edinburgh
name: David E Newby, MD PhD
role: STUDY_DIRECTOR
References:
citation: Forsythe RO, Dweck MR, McBride OMB, Vesey AT, Semple SI, Shah ASV, Adamson PD, Wallace WA, Kaczynski J, Ho W, van Beek EJR, Gray CD, Fletcher A, Lucatelli C, Marin A, Burns P, Tambyraja A, Chalmers RTA, Weir G, Mitchard N, Tavares A, Robson JMJ, Newby DE. 18F-Sodium Fluoride Uptake in Abdominal Aortic Aneurysms: The SoFIA3 Study. J Am Coll Cardiol. 2018 Feb 6;71(5):513-523. doi: 10.1016/j.jacc.2017.11.053.