Sodium Fluoride Imaging of Abdominal Aortic Aneurysms

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Abdominal aortic aneurysm
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Cook – Abdominal aortic aneurysm Cordis Corporation – Abdominal Aortic Aneurysm
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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