Fusion of CT Angiography With 3D Contrast Ultrasound as a Method for Follow up for Endovascular Aneurysm Repair

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Brief Title

Fusion of CT Angiography With 3D Contrast Ultrasound as a Method for Follow up for Endovascular Aneurysm Repair

Official Title

Fusion of CT Angiography (CTA ) With 3D Contrast Enhanced Ultrasound ( CEUS ) as a Method for Follow up After Endovascular Aneurysm Repair (EVR)

Brief Summary

      Abdominal Aortic Aneurysm (AAA) is a known vascular entity that may be life threatening
      condition .The most common treatment approach nowadays is the endovascular approach, a
      procedure known as endovascular aortic repair (EVAR). The most common procedure related
      complication is the expansion of the aneurysm from a "feeding vessel", usually a lumbar or
      intercostal artery. Another known complication is an endoleak from the stentgraft.Today,
      accepted EVAR follow up protocol consists of a multiple multiphasic CT angiography (CTA) scan
      . Hazards of these follow up CTA exams include repetitive radiation exposure, nephrotoxicity
      and allergic reactions. Ultrasonography is a useful method for detection and evaluation of
      AAA, has no ionizing radiation and is useful for the dynamic estimation of the aortic width
      in patients post EVAR. However, the sensitivity of ultrasonography solely for detection of
      endoleaks in post EVAR patients is not high.In recent years, the development of "fusion"
      applications allows the dual modality merge between ultrasound and CT scans that can be used
      as follow up examinations of known imaging findings on CT .Another application that had been
      developed for ultrasound machines is the ability to generate a 3 dimensional (3D)
      reconstruction which allows more precision. In the recent year the usage of intravenous
      contrast agent for ultrasonography based on microbubbles (BRACO SONOVIEW) has been approved
      by the Israeli ministry of health. This contrast agent is not nephrotoxic and the risk for
      allergic reaction is very low statistically similar to Gadolinium.A 3D contrast enhanced
      ultrasonography "fused" together with CTA may be an appropriate substitute for the standard
      CTA follow up in post EVAR patients and thus substantially reduce radiation doses as well as
      iodine contrast reactions and nephrotoxicity . The purpose of our research is to evaluate the
      combined modality (fusion of CTA with CEUS) mentioned above in the manner of radiation
      exposure and possible contrast media related adverse reaction reduction, thus allowing this
      method to become the possible gold standard exam for follow up EVAR patients.
    

Detailed Description

      Abdominal Aortic Aneurysm (AAA) is a known vascular entity that may be life threatening and
      requires treatment once it's diameter exceeds 5.5 cm or in any diameter in symptomatic
      patients.

      Known risk factors for developing Abdominal Aortic Aneurysm (AAA) include tabacco
      consumption, Sex (male predominance), age (above 65 with a history of smoking or age above 75
      without a history of smoking ), hypertension, diabetes mellitus and hyperchlesterolemia1 The
      most common treatment approach nowadays is the endovascular approach, a procedure known as
      endovascular aortic repair (EVAR). The most common procedure related complication is the
      expansion of the aneurysm from a "feeding vessel", usually a lumbar or intercostal artery.
      Another known complication is an endoleak from the stentgraft, through its proximal or distal
      part/.

      Today, accepted EVAR follow up protocol consists of a multiphasic CT angiography (CTA) scan
      .The initial scan is performed without contrast, the second scan is performed in the arterial
      phase and a third scan is performed in the late (portal) phase. CTA is performed 3,6 and12
      months after the procedure. After 12 months , follow up examinations are obtained annually.
      Hazards of these follow up CTA exams include repetitive radiation exposure, nephrotoxicity
      and allergic reactions.

      Ultrasonography is a useful method for detection and evaluation of AAA and is recommended as
      an annual screening tool for patients above 65 with smoking history or above 75 without
      smoking history. Duplex Ultrasonography has no ionizing radiation and is useful for the
      dynamic estimation of the aortic width in patients post EVAR. However, the sensitivity of
      ultrasonography solely for detection of endoleaks in post EVAR patients is not high, mostly
      due to known inborn limitations of ultrasound including decreased penetration in obese
      patients , and suboptimal demonstration of retroperitoneal structures due to gas in the
      intestine.

      In recent years, the development of "fusion" applications allow the dual modality merge
      between ultrasound and CT scans. The dual modality allows the direct comparison of imaging
      findings in real time. Fusion imaging is used as follow up examinations of known imaging
      findings on CT that cannot be optimally demonstrated on ultrasonography. Once these findings
      are followed up by ultrasonography, an substantial amount of radiation can be reduced.

      Another application that had been developed for ultrasound machines nowadays is the ability
      to generate a 3 dimensional (3D) reconstruction which allows more precision. 2D and 3D
      ultrasound imaging as a follow up imaging modality after endovascular aortic repair (EVAR)
      procedures has been described in medical literature3,4.

      In the recent year the usage of intravenous contrast agent for ultrasonography based on
      microbubbles (BRACO SONOVIEW) has been approved by the Israeli ministry of health. This
      intravenous contrast agent has been in usage for several years in Europe and have been
      recently approved officially in our country in the examination of liver, breast, vascular
      cerebral lesions and peripheral blood vessels. This contrast agent is not nephrotoxic and the
      risk for allergic reaction is very low statistically similar to Gadolinium. The contrast
      agent is purely intravascular and does not leak to the the interstitium, therefore can be
      used efficiently for the detection of endoleaks.

      This contrast agent has yet to be approved by ministry of health for the application in aorta
      imaging. Nevertheless, the European federation of societies for ultrasound in medicine and
      biology (EFSUMB) has specific guidelines for the usage of this contrast agent for the
      detection of stent grafts endoleaks (5) .

      A 3D contrast enhanced ultrasonography "fused" together with CTA may be an appropriate
      substitute for the standard CTA follow up in post EVAR patients and thus substantially reduce
      radiation doses as well as iodine contrast reactions and nephrotoxicity .

      The purpose of our research is to evaluate the combined modality (fusion of CTA with CEUS)
      mentioned above in the manner of radiation exposure and possible contrast media related
      adverse reaction reduction, thus allowing this method to become the possible gold standard
      exam for follow up EVAR patients.
    


Study Type

Interventional


Primary Outcome

Accuracy of the detection of endoleak by contrast 3D Ultrasound fused with CTA in the follow up of EVAR patients


Condition

Abdominal Aortic Aneurysm

Intervention

Contrast 3D Ultrasound

Study Arms / Comparison Groups

 all cohort
Description:  Patients will perform CTA 3 months after the EVAR procedure. Following CTA, an ultrasound examination which will include a 3D reconstruction and thereafter CEUS will be performed using SONOVIEW contrast agent. The dimensions and volume of the aorta will be compared to the measurements in CTA using the fusion method. The same protocol will be then performed 6 and 12 months post intervention.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

20

Start Date

March 2020

Completion Date

April 2023

Primary Completion Date

April 2022

Eligibility Criteria

        Inclusion Criteria

          -  Patients with a diagnosis of AAA

          -  AAA treated endovascularly

          -  Patients send from the outpatient clinic to a follow up imaging study

        Exclusion Criteria

        • AAA treated surgically and not endovascularly
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Erez Klein, MD, 97247772664, [email protected]



Administrative Informations


NCT ID

NCT04089241

Organization ID

490-19RMB


Responsible Party

Sponsor

Study Sponsor

Rambam Health Care Campus


Study Sponsor

Erez Klein, MD, Principal Investigator, Rambam Health Care Campus


Verification Date

September 2019