18F Sodium Fluoride PET/CT in Acute Aortic Syndrome

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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18F Sodium Fluoride PET/CT in Acute Aortic Syndrome

Conditions
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Acute Aortic Syndrome, Aortic Dissection, Penetrating Aortic Ulcer, Intramural Hematoma

Intervention / Treatment
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* Diagnostic Test: 18F Sodium Fluoride Positron Emission Tomography / Computed Tomography
* Diagnostic Test: CT Aortic Angiogram
* Diagnostic Test: Aortic MRI


Participation Criteria
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Eligibility Criteria
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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. Adults over the age of 25 years Participants who have had previous open or thoracic endovascular aortic repair (TEVAR) are eligible to participate in the study. Healthy Controls: No previous diagnosis of aortic disease Over the age of 55 years EXCLUSION CRITERIA: The inability of patients to undergo PET/CT scanning Chronic kidney disease (eGFR ≤ 30 mL/min/1.73 m2) Major or untreated cancer Pregnancy Allergy or contra-indication to iodinated contrast Inability or unwillingness to give informed consent

Ages Eligible for Study
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Minimum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Aortic Disease<br>Participants with normal calibre aortae and no prior diagnosis of acute aortic syndrome | Diagnostic Test: 18F Sodium Fluoride Positron Emission Tomography / Computed Tomography<br>* PET scan using the 18F-Sodium Fluoride radiotracer followed by an attenuation correction CT scan<br>Diagnostic Test: Aortic MRI<br>* Aortic MRI to assess aortic morphology and contextualise PET scan<br>|
| Acute Aortic Syndrome<br>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<br>* PET scan using the 18F-Sodium Fluoride radiotracer followed by an attenuation correction CT scan<br>Diagnostic Test: CT Aortic Angiogram<br>* CT scan to assess aortic morphology and contextualise PET scan<br>|
| Chronic Aortic Disease<br>Participants with an established diagnosis of acute aortic syndrome. | Diagnostic Test: 18F Sodium Fluoride Positron Emission Tomography / Computed Tomography<br>* PET scan using the 18F-Sodium Fluoride radiotracer followed by an attenuation correction CT scan<br>Diagnostic Test: CT Aortic Angiogram<br>* CT scan to assess aortic morphology and contextualise PET scan<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aortic diameter | Maximum cross-sectional aortic diameter | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 18F Sodium Fluoride uptake in the aorta | 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. | 12 months | 
| Hospital admissions | The requirement for hospital admission | 24 months | 
| Surgical Intervention | Requirement for surgical intervention during follow-up period | 24 months | 
| Change in renal function | Creatinine change during the follow-up period | 24 months | 
| Short Form-12 (SF12) questionnaire score | 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. | 24 months | 
| Disease related survival | Disease related survival | 24 months | 
| All-cause mortality | All-cause mortality | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sodium fluoride, positron emission tomography, computed tomography, acute aortic syndrome, aortic dissection, intramural haematoma, penetrating aortic ulcer