FAASt: 18F Sodium Fluoride PET/CT in Acute Aortic Syndrome
Study Details
Study Description
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 predict disease progression in acute aortic syndrome.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
Acute Aortic Syndrome encompasses multiple aortopathies, including aortic dissection, intramural haematoma and penetrating aortic ulcers. Acute aortic syndrome has a three year mortality approaching 25%. To date, other than the initial aortic diameter, there are no accurate methods of establishing the risk of disease progression in patients with acute aortic syndrome.
In vascular disease, microcalcification occurs in response to necrotic inflammation. Using computed tomography and positron emission tomography (PET-CT), early microcalcification 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. In abdominal aortic aneurysms, 18F-sodium fluoride binding predicts aortic expansion and the risk of aneurysm rupture or requirement for surgical repair.
The study investigators, therefore, propose to evaluate the ability of 18F-sodium fluoride to identify regions of necrotic inflammation in acute aortic syndrome to predict aortic expansion and disease progression.
Control patients with a normal calibre aorta will be recruited from the National Abdominal Aortic Aneurysm Screening Programme and Vascular Out-Patient Clinics. Patients with acute aortic syndrome and chronic aortic disease will undergo clinical assessments and 18F Sodium Fluoride PET/CT scans at baseline and 12-months. Clinical follow-up will continue for up to 3 years from recruitment.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Aortic Disease Participants with normal calibre aortae and no prior diagnosis of acute aortic syndrome |
Diagnostic Test: 18F Sodium Fluoride Positron Emission Tomography / Computed Tomography
PET scan using the 18F-Sodium Fluoride radiotracer followed by an attenuation correction CT scan
Diagnostic Test: Aortic MRI
Aortic MRI to assess aortic morphology and contextualise PET scan
|
| Acute Aortic Syndrome Participants presenting acutely with a diagnosis of acute aortic syndrome as defined in the European Society of Cardiology guidelines: a compatible clinical presentation with CT or magnetic resonance imaging confirming acute aortic syndrome. |
Diagnostic Test: 18F Sodium Fluoride Positron Emission Tomography / Computed Tomography
PET scan using the 18F-Sodium Fluoride radiotracer followed by an attenuation correction CT scan
Diagnostic Test: CT Aortic Angiogram
CT scan to assess aortic morphology and contextualise PET scan
|
| Chronic Aortic Disease Participants with an established diagnosis of acute aortic syndrome. |
Diagnostic Test: 18F Sodium Fluoride Positron Emission Tomography / Computed Tomography
PET scan using the 18F-Sodium Fluoride radiotracer followed by an attenuation correction CT scan
Diagnostic Test: CT Aortic Angiogram
CT scan to assess aortic morphology and contextualise PET scan
|
Outcome Measures
Primary Outcome Measures
- Aortic diameter [12 months]
Maximum cross-sectional aortic diameter
Secondary Outcome Measures
- 18F Sodium Fluoride uptake in the aorta [12 months]
18F Sodium Fluoride binding in the aorta will be measured from PET/CT scans performed at recruitment and at 12 months follow-up. Uptake will be quantified in Standardised Uptake Values and as a tissue to background ratios.
- Hospital admissions [24 months]
The requirement for hospital admission
- Surgical Intervention [24 months]
Requirement for surgical intervention during follow-up period
- Change in renal function [24 months]
Creatinine change during the follow-up period
- Short Form-12 (SF12) questionnaire score [24 months]
The SF12 is a validated, self reported quality of life assessment questionnaire. It consists of 12 questions that measure functional and mental well-being. Scores range from 12 to 47.
- Disease related survival [24 months]
Disease related survival
- All-cause mortality [24 months]
All-cause mortality
Other Outcome Measures
- Co-localisation of 18F-Sodium Fluoride with histological changes in aortic tissue [12 to 36 months]
Uptake of 18F-Sodium Fluoride will be identified on PET-CT scans that are acquired as part of the study visit. This will be compared with histological changes in aortic specimens obtained from participants undergoing open surgical repair.
Eligibility Criteria
Criteria
INCLUSION CRITERIA:
Patients with Acute Aortic Syndrome or Chronic Aortic Disease:
-
A diagnosis of acute aortic syndrome as defined as per the European Society of Cardiology guidelines on the management of aortic disease a compatible clinical presentation with CT or magnetic resonance imaging confirming acute aortic syndrome.
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Adults over the age of 25 years
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Participants who have had previous open or thoracic endovascular aortic repair (TEVAR) are eligible to participate in the study.
Healthy Controls:
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No previous diagnosis of aortic disease
-
Over the age of 55 years
EXCLUSION CRITERIA:
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The inability of patients to undergo PET/CT scanning
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Chronic kidney disease (eGFR ≤ 30 mL/min/1.73 m2)
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Major or untreated cancer
-
Pregnancy
-
Allergy or contra-indication to iodinated contrast
-
Inability or unwillingness to give informed consent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Royal Infirmary of Edinburgh | Edinburgh | United Kingdom | EH16 4SA |
Sponsors and Collaborators
- University of Edinburgh
- NHS Lothian
- British Heart Foundation
Investigators
- Principal Investigator: Maaz BJ Syed, MBChB MSc, University of Edinburgh
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AC18044