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

Using Ultrasound to Evaluate Aortic Aneurysm Size Based on 3D Co-registration to Previous Computerized Tomography

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.

Study Overview

• Status: Unknown
• Conditions: Aortic Aneurysm, Abdominal
• Intervention / Treatment: Device: US-CT Fusion examination

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 Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel, 3109601
    • Rambam healt care campus, Department of Medical Imaging

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
Evaluation of the pressure on the aneurysmal wall.	two years

Collaborators and Investigators

• Sponsor: Rambam Health Care Campus
• Investigators: Principal Investigator: Diana Gaitini, MD, Prof., Director of Ultrasound Unit, Rambam Health Care Campus

Publications and helpful links

General Publications

• 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. Erratum In: Circulation. 2011 Dec 6;124(23):e782.
• 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. Erratum In: J Vasc Surg. 2015 May;61(5):1382. J Vasc Surg. 2015 Sep;62(3):839.
• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Anticipated): April 1, 2018
• Study Completion (Anticipated): September 1, 2018

Study Registration Dates

• First Submitted: March 13, 2016
• First Submitted That Met QC Criteria: March 17, 2016
• First Posted (Estimate): March 23, 2016

Study Record Updates

• Last Update Posted (Estimate): March 23, 2016
• Last Update Submitted That Met QC Criteria: March 17, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
• Other Study ID Numbers: 0551-15 RMB CTIL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: undecided