Brief Title
Contrast Enhanced Ultrasound, Endoleak Detection Following EVAR v1.3
Official Title
Contrast Enhanced Ultrasound Endoleak Detection Compared To Time-Resolved Computer Tomography Angiography in High Risk Endovascular Aneurysm Repair (EVAR) Surveillance Patients.
Brief Summary
A single site cross-sectional comparison of paired diagnostic imaging modalities. This study will show the sensitivity and specificity of CEUS in detecting the various types of endoleaks, in comparison to tCTA, following EVAR. It will collect data to allow comparison of diagnostic accuracy across modalities including CDU, CEUS and tCTA. It will collect time taken to perform the various types of scan, to allow healthcare costs to be calculated for each imaging modality.
Detailed Description
This study will show the sensitivity and specificity of CEUS in detecting the various types of endoleaks, in comparison to tCTA, following EVAR. It will collect data to allow comparison of diagnostic accuracy across modalities including CDU, CEUS and tCTA. It will collect time taken to perform the various types of scan, to allow healthcare costs to be calculated for each imaging modality. Collected data will be analysed regarding two novel hypothesised methods of using CEUS information: The first is recording temporal delay between contrast in graft and contrast in endoleak to define endoleak type. Potentially this could be used as a faster method of defining endoleak type in a surveillance programme. The second is to identify/refute correlation between CEUS contrast to appear in endoleak vs tCTA contrast to appear in endoleak. If an association can be established, CEUS timings could potentially then be used to time 'standard' CTA phases to improve CTAs diagnostic accuracy.
Study Type
Observational
Primary Outcome
Ability to detect type I/III endoleak on CEUS as defined by presence/absence on tCTA
Secondary Outcome
Ability to detect type II endoleak on CEUS as defined by presence/absence on tCTA
Condition
Endoleak
Intervention
time-resolved CT Angiography
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Radiation
Estimated Enrollment
30
Start Date
January 20, 2016
Completion Date
March 20, 2018
Primary Completion Date
March 20, 2018
Eligibility Criteria
Inclusion Criteria: 1. Aged 18 or over 2. Able to give informed consent 3. Undergone an EVAR of infra-renal abdominal aortic aneurysm 4. Planned for CTA of EVAR Exclusion Criteria: 1. Unable to receive CTA Contrast Allergy, Insufficient renal function for standard outpatient contrast study (eGFR <45) Overactive thyroid gland 2. Unable to receive CEUS contrast Previous reaction to Sonovue (Ultrasound Contrast) Allergy to sulphur hexafluoride (used in electrical industry in circuit breakers, switch gears & electrical equipment) Recent acute coronary syndrome or unstable angina, typical angina at rest or frequent or repeated angina/chest pain - all within previous 7 days Recent coronary intervention 3. Previous embolization of artery in region of EVAR (affects imaging quality) 4. BMI >30 (affects imaging quality)
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Srinivasa R Vallabhaneni, MD, ,
Location Countries
United Kingdom
Location Countries
United Kingdom
Administrative Informations
NCT ID
NCT02688751
Organization ID
5083
Secondary IDs
15/NW/0908
Responsible Party
Sponsor
Study Sponsor
Liverpool University Hospitals NHS Foundation Trust
Study Sponsor
Srinivasa R Vallabhaneni, MD, Study Chair, Liverpool University Hospitals NHS Foundation Trust
Verification Date
September 2016