- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04615559
Contrast Enhanced Ultrasound Endoleak Identification and Classification
Contrast Enhanced Ultrasound Endoleak Identification and Classification Compared to Computed Tomography in High-risk Complicated Aneurysm Repair Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Introduction: 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.
Rationale: The most commonly accepted tool for follow up is Computed Tomography (CT) scan which involves ionizing radiation and potentially nephrotoxic iodinated contrast. Routine ultrasound with Doppler, CT, and MRI has all been employed utilizing various imaging protocols. 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 also allows continuous (dynamic) or real-time monitoring of the aneurysm and endoleak throughout the study.
Objectives:
Aim 1: To determine the consistency/discrepancy of endoleak detection (positive/negative) for contrast enhanced ultrasound (CEUS) versus various phases of CTA versus delayed phase CTA.
Aim 2 (Exploratory): To explore the consistency/discrepancy of endoleak type (type 1-5) between CEUS and delayed phase CTA.
Aim 3 (Exploratory): To explore the consistency/discrepancy of endoleak source detected (positive/negative for each source) for type II endoleaks between CEUS and CTA.
Aim 4 (Exploratory): Re-assess Aims 1-3 for the follow-up scans. The goal for this aim is to examine whether the consistency/discrepancy patterns discovered in Aims 1-3 can be repeated at the follow-up scans.
Population: 40 patients who have undergone an EVAR or FEVAR for abdominal aortic aneurysms and are expected to have CTA as part of their standard of care will be enrolled in the study.
Methodology: Patients will be evaluated with research contrast ultrasound at one month post-op, six months post-op and at one year.
Data Analysis Plan: 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. 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. In the situation with high agreement biased towards one endoleak type, or extremely unbalanced distribution of endoleak types, prevalence-adjusted bias-adjusted kappa coefficient (PABAK) (Byrt, Bishop, and Carlin 1993) will be used. The discrepancy of endoleak type between CEUS and delayed phase CTA will be reported as rate, for example percent of case rated as type 1 in CTA but type 2 in delayed phase, with Clopper Pearson Exact 95% confidence interval. SAS9.4 will be used for all statistical analyses.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Los Angeles, California, United States, 90033
- USC Department of Radiology
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 1. 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: contrast enhanced ultrasound
CEUS will be performed at one month post-op, six months post-op and at one year.
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To determine the sensitivity and specificity for CEUS and various CTA phases when using delay phase of CTA as the gold standard
Time Frame: 24 months
|
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
Time Frame: 24 months
|
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
|
Collaborators and Investigators
Investigators
- Principal Investigator: Edward Grant, University of Southern California
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HS-20-00428
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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