Using US to Evaluate Aortic Aneurysm Size Based on 3D Co-registration to Previous CT Scan

• Conditions: Aortic Aneurysm, Abdominal
• Interventions: Device: US-CT Fusion examination

• Registration Number: NCT02717481
• Lead Sponsor: Rambam Health Care Campus

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.

Study Timeline

• Status Verified: 2016-03
• Study First Submitted: 2016-03-13
• Study First Submitted QC: 2016-03-17
• Last Update Submitted: 2016-03-17
• Study First Posted: 2016-03-23
• Last Update Posted: 2016-03-23
• Study Start: 2016-04
• Primary Completion: 2018-04
• Study Completion: 2018-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with known aortic aneurysm	US-CT Fusion examination	Patients with known abdominal aortic aneurysm diagnosed in clinical follow-up or after an invasive procedure to repair it. US-CT Fusion examination

Primary Outcome Measures

Name	Time	Method
Exact and reliable evaluation of the aneurysm size	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.

Secondary Outcome Measures

Name	Time	Method
Evaluation of the pressure on the aneurysmal wall.	two years
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

Trial Locations

Locations (1)

Rambam healt care campus, Department of Medical Imaging; 🇮🇱 Haifa, Israel