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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

Tracking Information
First Submitted Date August 25, 2014
First Posted Date August 29, 2014
Last Update Posted Date May 17, 2017
Study Start Date September 2014
Actual Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 28, 2014)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02229006 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: August 28, 2014)
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 15, 2017)
  • 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.
  • 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.
  • 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
Original Other Pre-specified Outcome Measures
 (submitted: August 28, 2014)
  • 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.
  • 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.
 
Descriptive Information
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
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Abdominal Aortic Aneurysm
Intervention Radiation: 18F-NaF PET-CT
Study Groups/Cohorts
  • Aneurysm surveillance
    Radiation: 18F-NaF PET-CT
    Intervention: Radiation: 18F-NaF PET-CT
  • Control patients
    Radiation: 18F-NaF PET-CT
    Intervention: Radiation: 18F-NaF PET-CT
Publications * 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. (18)F-Sodium Fluoride Uptake in Abdominal Aortic Aneurysms: The SoFIA(3) Study. J Am Coll Cardiol. 2018 Feb 6;71(5):513-523. doi: 10.1016/j.jacc.2017.11.053.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 15, 2017)
96
Original Estimated Enrollment
 (submitted: August 28, 2014)
100
Actual Study Completion Date February 2017
Actual Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT02229006
Other Study ID Numbers ETM/365
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of Edinburgh
Study Sponsor University of Edinburgh
Collaborators 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
PRS Account University of Edinburgh
Verification Date October 2016