Abdominal Aortic AneurysmNCT04615559
Contrast Enhanced Ultrasound Endoleak Identification and Classification
A study testing Contrast enhanced ultrasound in people with Abdominal Aortic Aneurysm, run by University of Southern California at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysm
- What is being tested?
- Contrast enhanced ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2020to Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
USC Department of Radiology
Los Angeles, California, 90033
About this study
Official title: Contrast Enhanced Ultrasound Endoleak Identification and Classification Compared to Computed Tomography in High-risk Complicated Aneurysm Repair Patients
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.
Read the 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.
- Conditions
- Abdominal Aortic Aneurysm
- Being tested
- Contrast enhanced ultrasound
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contrast enhanced ultrasoundDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| contrast enhanced ultrasound | Experimental | CEUS will be performed at one month post-op, six months post-op and at one year. Receives: Diagnostic Test: Contrast enhanced ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2020
- Study startDec 2020 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionJul 2023 (estimated)
Why it stopped: The study team did not proceed with study start-up.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Aortic AneurysmStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edward Grant, University of Southern California
- Investigators
- Edward Grant, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04615559
- Sponsor's protocol ID
- HS-20-00428
- Status last verified
- Nov 2022
- First submitted
- 28 Oct 2020
- Last updated
- 14 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contrast Enhanced Ultrasound Endoleak Identification and Classification Compared to Computed Tomography in High-risk Complicated Aneurysm Repair Patients
- ClinicalTrials.gov ID
- NCT04615559
- Acronym / sponsor ID
- HS-20-00428
- Conditions
- Abdominal Aortic Aneurysm
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study team did not proceed with study start-up.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- Dec 2020 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 4 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| contrast enhanced ultrasound | Experimental | Diagnostic Test: Contrast enhanced ultrasoundCEUS will be performed at one month post-op, six months post-op and at one year. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Contrast enhanced ultrasoundCEUS 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 | Diagnostic test | contrast enhanced ultrasound |
Primary outcome
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.
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward Grant principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contrast enhanced ultrasound in people with Abdominal Aortic Aneurysm, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2022.