- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02229006
Sodium Fluoride Imaging of Abdominal Aortic Aneurysms (SoFIA3)
SoFIA3: Sodium Fluoride Imaging (18F-NaF PET-CT) in Abdominal Aortic Aneurysms
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Edinburgh, United Kingdom, EH16 4SA
- Royal Infirmary of Edinburgh
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Aneurysm surveillance
Radiation: 18F-NaF PET-CT
|
|
Control patients
Radiation: 18F-NaF PET-CT
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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:
The maximum AP diameter will also be recorded on CTA performed at the time of study visit. |
0, 6, 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
At baseline
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
At baseline
|
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. |
At baseline
|
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
|
At baseline
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Rachael O Forsythe, MD, University of Edinburgh
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ETM/365
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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