NCT02229006

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 29, 2014

Completed
3 days until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

May 17, 2017

Status Verified

October 1, 2016

Enrollment Period

2.3 years

First QC Date

August 25, 2014

Last Update Submit

May 15, 2017

Conditions

Abdominal Aortic Aneurysm

Keywords

Aortic aneurysm, abdominalSodium FluoridePositron Emission Tomography

Outcome Measures

Primary Outcomes (1)

  • Change in abdominal aortic aneurysm anteroposterior diameter over time at 6 and 12 months (mm)

    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.

    0, 6, 12 months

Secondary Outcomes (1)

  • Co-localisation of 18F-NaF with USPIO uptake on MRI scanning

    At baseline

Other Outcomes (3)

  • Co-localisation of 18F-NaF with histological evidence of active calcification, necrotic inflammation and proteolytic degradation of the aneurysm wall

    At baseline

  • Relationship with areas of high wall stress (finite element analysis)

    At baseline

  • Comparison of 18F-NaF uptake in patients with AAA versus control patients

    At baseline

Study Arms (2)

Aneurysm surveillance

Radiation: 18F-NaF PET-CT

Radiation: 18F-NaF PET-CT

Control patients

Radiation: 18F-NaF PET-CT

Radiation: 18F-NaF PET-CT

Interventions

18F-NaF PET-CTRADIATION
Aneurysm surveillanceControl patients

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • Patients already enrolled in the MA3RS study (ISRCTN76413758)
  • Patients with abdominal aortic aneurysm with AP diameter \>40 mm on ultrasound
  • \>50 years of age
  • Patients with abdominal aorta with AP diameter \<30 mm on ultrasound
  • \>50 years of age

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Infirmary of Edinburgh

Edinburgh, EH16 4SA, United Kingdom

Location

Related Publications (2)

  • Debono S, Tzolos E, Syed MBJ, Nash J, Fletcher AJ, Dweck MR, Newby DE, Dey D, Forsythe RO, Williams MC. CT Attenuation of Periaortic Adipose Tissue in Abdominal Aortic Aneurysms. Radiol Cardiothorac Imaging. 2024 Feb;6(1):e230250. doi: 10.1148/ryct.230250.

    PMID: 38329405DERIVED

  • 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.

    PMID: 29406857DERIVED

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic AneurysmAneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Study Officials

  • Rachael O Forsythe, MD

    University of Edinburgh

    PRINCIPAL INVESTIGATOR

  • David E Newby, MD PhD

    University of Edinburgh

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2014

First Posted

August 29, 2014

Study Start

September 1, 2014

Primary Completion

January 1, 2017

Study Completion

February 1, 2017

Last Updated

May 17, 2017

Record last verified: 2016-10

Locations

GB(1)