Abdominal Aortic AneurysmSoFIA3NCT02229006
Sodium Fluoride Imaging of Abdominal Aortic Aneurysms
An observational study of Abdominal Aortic Aneurysm, run by University of Edinburgh at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Abdominal Aortic Aneurysm
- What is being tested?
- 18F-NaF PET-CT
- Type of treatment
- Surgery or procedure
- How many people
- 96 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2014to Feb 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Renal dysfunction (eGFR <30ml/min/1.73m2)
- Contraindication to PET-CT or CTA
- Iodine allergy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SoFIA3: Sodium Fluoride Imaging (18F-NaF PET-CT) in Abdominal Aortic Aneurysms
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.
Read the 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.
- Conditions
- Abdominal Aortic Aneurysm
- Being tested
- 18F-NaF PET-CT
- Keywords
- Aortic aneurysm, abdominal, Sodium Fluoride, Positron Emission Tomography
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-NaF PET-CTRadiation
| Study group | Role | What they receive |
|---|---|---|
| Aneurysm surveillance | Radiation: 18F-NaF PET-CT Receives: Radiation: 18F-NaF PET-CT | |
| Control patients | Radiation: 18F-NaF PET-CT Receives: Radiation: 18F-NaF PET-CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- At (or close to) the time of the study visit
- 6 months following the study visit
- 12 months following the study visit
The maximum AP diameter will also be recorded on CTA performed at the time of study visit.
Measured: 0, 6, 12 months
Secondary outcomes (1)
Co-localisation of 18F-NaF with USPIO uptake on MRI scanning
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.
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2014 (estimated)
- Study startSep 2014
- Primary completionJan 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Abdominal Aortic AneurysmStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Chief Scientist Office of the Scottish Government
- Responsible party
- Sponsor
- Investigators
- Rachael O Forsythe, MD, Principal investigator, University of EdinburghDavid E Newby, MD PhD, Study director, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02229006
- Sponsor's protocol ID
- ETM/365
- Acronym
- SoFIA3
- Status last verified
- Oct 2016
- First submitted
- 25 Aug 2014
- Last updated
- 17 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Forsythe RO, McBride OMB, Robson JMJ, Vesey AT, Winarski AC, Weston C, Debono S, Semple SI, Gray CD, MacGillivray TJ, Brittenden J, Roditi G, Stuart W, van Beek EJR, Tambyraja AL, Williams MC, Dweck MR, Newby DE. Macrophage-mediated inflammation and microcalcification are associated with abdominal aortic aneurysm progression and clinical events. Br J Surg. 2026 Aug 12:znag100. doi: 10.1093/bjs/znag100. Online ahead of print.
PubMed 42583886Debono 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.
PubMed 38329405Forsythe 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.
PubMed 29406857
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SoFIA3: Sodium Fluoride Imaging (18F-NaF PET-CT) in Abdominal Aortic Aneurysms
- ClinicalTrials.gov ID
- NCT02229006
- Acronym / sponsor ID
- SoFIA3 / ETM/365
- Conditions
- Abdominal Aortic Aneurysm
- Keywords
- Aortic aneurysm, abdominal, Sodium Fluoride, Positron Emission Tomography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- Chief Scientist Office of the Scottish Government
- Study start
- Sep 2014
- Primary completion
- Jan 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 29 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aneurysm surveillance | – | Radiation: 18F-NaF PET-CTRadiation: 18F-NaF PET-CT |
| Control patients | – | Radiation: 18F-NaF PET-CTRadiation: 18F-NaF PET-CT |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-NaF PET-CT | Radiation | Aneurysm surveillance, Control patients |
Primary outcome
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.
1 secondary outcome
Co-localisation of 18F-NaF with USPIO uptake on MRI scanning
Time frame: At baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2017.
- Derived from this study: PubMed 42583886Forsythe RO, McBride OMB, Robson JMJ, Vesey AT, Winarski AC, Weston C, Debono S, Semple SI, Gray CD, MacGillivray TJ, Brittenden J, Roditi G, Stuart W, van Beek EJR, Tambyraja AL, Williams MC, Dweck MR, Newby DE. Macrophage-mediated inflammation and microcalcification are associated with abdominal aortic aneurysm progression and clinical events. Br J Surg. 2026 Aug 12:znag100. doi: 10.1093/bjs/znag100. Online ahead of print.
- Derived from this study: PubMed 38329405Debono 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.
- Derived from this study: PubMed 29406857Forsythe 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachael O Forsythe, MD principal investigator
University of Edinburgh
David E Newby, MD PhD study director
University of Edinburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Aortic Aneurysm, run by University of Edinburgh at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in abdominal aortic aneurysm anteroposterior diameter over time at 6 and 12 months (mm) (time frame: 0, 6, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02229006, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2017.