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Sodium Fluoride Imaging of Abdominal Aortic Aneurysms (SoFIA3)

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ClinicalTrials.gov Identifier: NCT02229006
Recruitment Status : Completed
First Posted : August 29, 2014
Last Update Posted : May 17, 2017
Sponsor:
Collaborator:
Chief Scientist Office of the Scottish Government
Information provided by (Responsible Party):
University of Edinburgh

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.

Condition or disease Intervention/treatment
Abdominal Aortic Aneurysm Radiation: 18F-NaF PET-CT

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
Actual Enrollment : 96 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: SoFIA3: Sodium Fluoride Imaging (18F-NaF PET-CT) in Abdominal Aortic Aneurysms
Study Start Date : September 2014
Actual Primary Completion Date : January 2017
Actual Study Completion Date : February 2017


Group/Cohort Intervention/treatment
Aneurysm surveillance
Radiation: 18F-NaF PET-CT
Radiation: 18F-NaF PET-CT
Control patients
Radiation: 18F-NaF PET-CT
Radiation: 18F-NaF PET-CT



Primary Outcome Measures :
  1. Change in abdominal aortic aneurysm anteroposterior diameter over time at 6 and 12 months (mm) [ Time Frame: 0, 6, 12 months ]

    The maximum AAA AP diameter on ultrasound will be obtained from time points below:

    1. At (or close to) the time of the study visit
    2. 6 months following the study visit
    3. 12 months following the study visit

    The maximum AP diameter will also be recorded on CTA performed at the time of study visit.



Secondary Outcome Measures :
  1. Co-localisation of 18F-NaF with USPIO uptake on MRI scanning [ Time Frame: At baseline ]

    The data on USPIO uptake on MRI scanning will be derived from a separate study (MA3RS - MRI in AAA to predict Rupture or Survival, ISRCTN76413758). The proposed study described here (SoFIA3) will not involve any administration of USPIO.

    Regions of interest and uptake of 18F-NaF will be identified on PET-CT images acquired at baseline as part of this study (SoFIA3). These images will be co-registered to MRI data (uptake pre- and post-USPIO) which has already been obtained during the MA3RS Study. We will correlate the agreement between areas of significant 18F-NaF uptake on PET-CT (representing areas of active calcification) and areas of significant USPIO uptake on MRI (representing areas of active macrophage activity).

    This is an exploratory analysis which will take advantage of data already obtained through the MA3RS Study, which is a separate study.



Other Outcome Measures:
  1. Co-localisation of 18F-NaF with histological evidence of active calcification, necrotic inflammation and proteolytic degradation of the aneurysm wall [ Time Frame: At baseline ]

    Uptake of 18F-NaF will be identified on PET-CT scans that are acquired as part of the study visit. We will take advantage of histological tissue specimens that will be collected as part of the separate MA3RS Study (patients enrolled in the MA3RS Study who undergo AAA repair give consent to tissue samples being take and analysed).

    We will take advantage of histological data that is already obtained from the MA3RS study and use this to correlate histological areas of inflammation with areas of active calcification on PET-CT.


  2. Relationship with areas of high wall stress (finite element analysis) [ Time Frame: At baseline ]

    As part of the MA3RS Study, patients will undergo CTA scans at baseline and 24 months. These are being used by other members of the team in the development of novel imaging techniques to quantify areas of high wall stress, through finite element analysis.

    The extra CTA and calcium scoring scans acquired as part of SoFIA3 (which could be at any time following the first MA3RS CTA) may contribute to this image analysis technique.


  3. Comparison of 18F-NaF uptake in patients with AAA versus control patients [ Time Frame: At baseline ]
    We will compare objective measures of tracer uptake in AAA vs control aorta



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02229006


Locations
United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, United Kingdom, EH16 4SA
Sponsors and Collaborators
University of Edinburgh
Chief Scientist Office of the Scottish Government
Investigators
Principal Investigator: Rachael O Forsythe, MD University of Edinburgh
Study Director: David E Newby, MD PhD University of Edinburgh

Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT02229006     History of Changes
Other Study ID Numbers: ETM/365
First Posted: August 29, 2014    Key Record Dates
Last Update Posted: May 17, 2017
Last Verified: October 2016

Keywords provided by University of Edinburgh:
Aortic aneurysm, abdominal
Sodium Fluoride
Positron Emission Tomography

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Fluorides
Sodium Fluoride
Listerine
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents