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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with known aortic aneurysm | Patients with known abdominal aortic aneurysm diagnosed in clinical follow-up or after an invasive procedure to repair it. US-CT Fusion examination |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| US-CT Fusion examination | Device | Patients will undergo an US examination using an US device with US-CT Fusion capabilities. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Exact and reliable evaluation of the aneurysm size | The size of the aneurysm will be evaluated by two different doctors or twice with large time frame between the studies. The difference between the measurements with the fusion technology will be compared to the difference without the fusion technology. The accuracy of the measurement will be evaluated by comparing to previous CT examination. | two years |
| Measure | Description | Time Frame |
|---|---|---|
| The size difference between systolic and diastolic aneurysm. | two years | |
| Aneurysm neck size and changes following an invasive procedure to repair it (EVAR). | two years | |
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Inclusion Criteria:
•Patients with abdominal aortic aneurysm diagnosis in clinical follow-up or after an invasive procedure to fix it.
Exclusion Criteria:
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Patients with abdominal aortic aneurysm diagnosis in clinical follow-up or after an invasive procedure to fix it
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Diana Gaitini, MD, Prof. | Contact | +972-4-7773675 | d_gaitini@rambam.health.gov.il | |
| Gil Zur, MD | Contact | +972-52-3504502 | g_zur@rambam.health.gov.il |
| Name | Affiliation | Role |
|---|---|---|
| Diana Gaitini, MD, Prof. | Director of Ultrasound Unit, Rambam Health Care Campus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rambam healt care campus, Department of Medical Imaging | Haifa | 3109601 | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21911788 | Background | 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. | |
| 25175634 | Background | 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. |
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| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Evaluation of the pressure on the aneurysmal wall. |
| two years |
| 26484714 | Background | 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. |
| D001018 |
| Aortic Diseases |