Contrast Enhanced Ultrasound Endoleak Identification and Classification

NCT04615559 | Withdrawn FDA Device

• 1 other identifier: HS-20-00428
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Surgery for abdominal aortic pathology usually occurs in the setting of advanced cardiovascular disease. The repair can be relatively simple or complex with multiple steps including open repair, placing a stent with a catheter, and placing a complicated stent that allows for crossing vessels without occluding them. All these repairs require imaging follow up. The most commonly accepted tool for follow up is Computed Tomography (CT) scan which involves ionizing radiation and potentially nephrotoxic iodinated contrast. Recommendations for the time interval for follow up, as well the radiology imaging technique vary. Routine ultrasound with Doppler, CT, and MRI has all been employed utilizing various imaging protocols. Clinicians use non-contrast CT, arterial phase and delayed phase CT, ultrasound, and various combinations based on personal experience and patient pathology. Concerns over cost, potential nephrotoxicity of contrast agents and repeated radiation exposure has led to investigation of alternate imaging modalities such as contrast-enhanced ultrasound (CEUS). CEUS represents an improvement of ultrasound imaging but comparisons against CT report widely varying results, likely due to technical factors of CEUS and limitations of single-phase CTA. Contrast ultrasound has been used effectively to diagnose leaks in the aorta post repair and is without the radiation and potential nephrotoxicity of iodinated contrast. Of yet, no large prospective studies have compared CT and contrast US and no studies have looked at the more complicated staged or fenestrated repairs. This study proposes to perform a contrast ultrasound at the same time as a contrast CT using a standardized protocol. This protocol would include a non-contrast CT, angiographic CT, and a CT in a delayed phase in all patients as standard of care. We will compare the results of a contrast US with the various data derived from a three phase CT.

Conditions

Abdominal Aortic Aneurysm

Outcome Measures

Primary Outcomes (2)

• To determine the sensitivity and specificity for CEUS and various CTA phases when using delay phase of CTA as the gold standard

  Binomial 95% confidence interval will be calculated for sensitivity and specificity. One- sided binomial test will be conducted to test whether the target sensitivity and specificity are superior to the null value, e.g. a minimal acceptable level of sensitivity and specificity.

  24 months

• Is there any endoleak positive on CEUS or various phases of the CTA but negative on CTA in the delayed phase

  In detecting the rate of endoleak positive on CEUS or other phases of the CTA but negative on CTA in the delayed phase, we will compute Clopper Pearson Exact 95% confidence interval since such a rate could be small. To assess consistency of endoleak type (type 1-5) between CEUS and delayed phase CTA, Kappa coefficient will be used.

  24 months

Study Arms (1)

contrast enhanced ultrasound

EXPERIMENTAL

CEUS will be performed at one month post-op, six months post-op and at one year.

Diagnostic Test: Contrast enhanced ultrasound

Interventions

Contrast enhanced ultrasound DIAGNOSTIC_TEST

CEUS involves the use of microbubble contrast agents and specialized imaging techniques to enhance the signal from blood, thus showing flow in macroscopic vessels as well as tissue perfusion information

contrast enhanced ultrasound

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Aged 18 or over 2. Able to give informed consent 3. Undergone an EVAR or FEVAR for abdominal aortic aneurysms 4. Expected to have CTA

You may not qualify if:

• Unable to receive CTA (Contrast Allergy, Insufficient renal function for standard outpatient contrast study (eGFR \<30) Overactive thyroid gland)
• Unable to receive CEUS contrast, previous reaction to Ultrasound Contrast Agent (UCA)
• BMI \>50

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

USC Department of Radiology

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• Edward Grant

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Radiology

Study Record Dates

• First Submitted: October 28, 2020
• First Posted: November 4, 2020
• Study Start: December 1, 2020
• Primary Completion: December 1, 2022
• Study Completion: July 1, 2023
• Last Updated: November 14, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)