Clinical trial NCT02717481: Using US to Evaluate Aortic Aneurysm Size Based on 3D Co-registration to Previous CT Scan
Official title: Using Ultrasound to Evaluate Aortic Aneurysm Size Based on 3D Co-registration to Previous Computerized Tomography
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aortic Aneurysm, Abdominal
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2016-03-23
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with abdominal aortic aneurysm diagnosis in clinical follow-up or after an invasive procedure to fix it

Brief summary: Examine a new method based on fusion between ultrasound (US) and previous ultrasound/computerized tomography(US/CT) studies to evaluate the size of abdominal aneurysm and measure the changes over time and following invasive repair procedure.

Detailed description: Selection test for assessing aortic aneurysm is CT angio, it performed after injection of contrast material and allows a complete demonstration of the blood vessels. This test exposes the patient to ionizing radiation and the injection of iodine contrast medium. Repeated tests pose a risk of developing a malignancy in the future due to the use of ionizing radiation and risk of renal impairment and allergic reactions due to the injection of contrast material. Ultrasound is another test that enables the detection and evaluation of aortic aneurysm. Patients with a known diagnosis of aortic aneurysm detected on CT are required to continuous monitoring in light of its growth over time and the risk of rupture.

Using Co-registration over the US device will enable to conduct a US directed aorta examination, which uses the information produced from the CT as a "roadmap" for detection and localization of the aneurysm. That can theoretically improve detection capabilities and characteristics of the aneurysm and outcomes of the invasive treatment.

Eligibility criteria: Inclusion Criteria:

•Patients with abdominal aortic aneurysm diagnosis in clinical follow-up or after an invasive procedure to fix it.

Exclusion Criteria:

* Inability to perform Ultrasound
* Pace maker
* Hemodynamic instability
* Inability to cooperate in US examination
* Pregnant Women - does not undergo CT

Primary outcomes:
measure: Exact and reliable evaluation of the aneurysm size
timeFrame: two years
Secondary outcomes:
measure: The size difference between systolic and diastolic aneurysm.
timeFrame: two years
measure: Aneurysm neck size and changes following an invasive procedure to repair it (EVAR).
timeFrame: two years
measure: Evaluation of the pressure on the aneurysmal wall.
timeFrame: two years
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam healt care campus, Department of Medical Imaging
Study officials:
affiliation: Director of Ultrasound Unit, Rambam Health Care Campus
name: Diana Gaitini, MD, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kobeiter H, Nahum J, Becquemin JP. Zero-contrast thoracic endovascular aortic repair using image fusion. Circulation. 2011 Sep 13;124(11):e280-2. doi: 10.1161/CIRCULATIONAHA.110.014118. No abstract available.
citation: McNally MM, Scali ST, Feezor RJ, Neal D, Huber TS, Beck AW. Three-dimensional fusion computed tomography decreases radiation exposure, procedure time, and contrast use during fenestrated endovascular aortic repair. J Vasc Surg. 2015 Feb;61(2):309-16. doi: 10.1016/j.jvs.2014.07.097. Epub 2014 Aug 28.
citation: Pfister K, Schierling W, Jung EM, Apfelbeck H, Hennersperger C, Kasprzak PM. Standardized 2D ultrasound versus 3D/4D ultrasound and image fusion for measurement of aortic aneurysm diameter in follow-up after EVAR. Clin Hemorheol Microcirc. 2016;62(3):249-60. doi: 10.3233/CH-152012.