18F Sodium Fluoride PET/CT in Acute Aortic Syndrome

Aortic Dissection Clinical Trial

— FAASt  

Official title:

18F Sodium Fluoride PET/CT in Acute Aortic Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03647566
• Other study ID #: AC18044
• Status: Completed
• Start date: October 1, 2018
• Est. completion date: February 1, 2021

Study information

• Verified date: April 2020
• Source: University of Edinburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 predict disease progression in acute aortic syndrome.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: February 1, 2021
• Est. primary completion date: February 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Aortic Syndrome
• Aneurysm, Dissecting
• Aortic Dissection
• Hematoma
• Intramural Hematoma
• Penetrating Aortic Ulcer
• Syndrome

Intervention

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
• CT Aortic Angiogram
CT scan to assess aortic morphology and contextualise PET scan
• Aortic MRI
Aortic MRI to assess aortic morphology and contextualise PET scan

Locations

Country	Name	City	State
United Kingdom	Royal Infirmary of Edinburgh	Edinburgh

Sponsors (3)

Lead Sponsor	Collaborator
University of Edinburgh	British Heart Foundation, NHS Lothian

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Co-localisation of 18F-Sodium Fluoride with histological changes in aortic tissue	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.	12 to 36 months
Primary	Aortic diameter	Maximum cross-sectional aortic diameter	12 months
Secondary	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
Secondary	Hospital admissions	The requirement for hospital admission	24 months
Secondary	Surgical Intervention	Requirement for surgical intervention during follow-up period	24 months
Secondary	Change in renal function	Creatinine change during the follow-up period	24 months
Secondary	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
Secondary	Disease related survival	Disease related survival	24 months
Secondary	All-cause mortality	All-cause mortality	24 months