Using US to Evaluate Aortic Aneurysm Size Based on 3D Co-registration to Previous CT Scan
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|ClinicalTrials.gov Identifier: NCT02717481|
Recruitment Status : Unknown
Verified March 2016 by Rambam Health Care Campus.
Recruitment status was: Not yet recruiting
First Posted : March 23, 2016
Last Update Posted : March 23, 2016
|Condition or disease||Intervention/treatment|
|Aortic Aneurysm, Abdominal||Device: US-CT Fusion examination|
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.
|Study Type :||Observational|
|Estimated Enrollment :||120 participants|
|Official Title:||Using Ultrasound to Evaluate Aortic Aneurysm Size Based on 3D Co-registration to Previous Computerized Tomography|
|Study Start Date :||April 2016|
|Estimated Primary Completion Date :||April 2018|
|Estimated Study Completion Date :||September 2018|
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
Device: US-CT Fusion examination
Patients will undergo an US examination using an US device with US-CT Fusion capabilities.
- Exact and reliable evaluation of the aneurysm size [ Time Frame: two years ]
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.
- The size difference between systolic and diastolic aneurysm. [ Time Frame: two years ]
- Aneurysm neck size and changes following an invasive procedure to repair it (EVAR). [ Time Frame: two years ]
- Evaluation of the pressure on the aneurysmal wall. [ Time Frame: two years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02717481
|Contact: Diana Gaitini, MD, Prof.||+email@example.com|
|Contact: Gil Zur, MDfirstname.lastname@example.org|
|Rambam healt care campus, Department of Medical Imaging|
|Haifa, Israel, 3109601|
|Contact: Diana Gaitini, MD, Prof. +972 (4)777-2664 email@example.com|
|Principal Investigator:||Diana Gaitini, MD, Prof.||Director of Ultrasound Unit, Rambam Health Care Campus|