Aortic Aneurysm, AbdominalNCT02717481
Using US to Evaluate Aortic Aneurysm Size Based on 3D Co-registration to Previous CT Scan
An observational study of Aortic Aneurysm, Abdominal, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Aneurysm, Abdominal
- What is being tested?
- US-CT Fusion examination
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2016to Sep 2018
- Phase
- Observational
- 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
Study population: Patients with abdominal aortic aneurysm diagnosis in clinical follow-up or after an invasive procedure to fix it
Who may be able to join
- •Patients with abdominal aortic aneurysm diagnosis in clinical follow-up or after an invasive procedure to fix it.
Who cannot join
- Inability to perform Ultrasound
- Pace maker
- Hemodynamic instability
- Inability to cooperate in US examination
- Pregnant Women - does not undergo CT
Trial locations and contacts
1 site in 1 country.
Israel1 site
Rambam healt care campus, Department of Medical Imaging
Haifa, 3109601
Diana Gaitini, MD, Prof., +972 (4)777-2664, d_gaitini@rambam.health.gov.il
About this study
Official title: 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.
Read the 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.
- Conditions
- Aortic Aneurysm, Abdominal
- Being tested
- US-CT Fusion examination
- 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.
US-CT Fusion examinationDevice
Patients will undergo an US examination using an US device with US-CT Fusion capabilities.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: US-CT Fusion examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: two years
Secondary outcomes (3)
The size difference between systolic and diastolic aneurysm.
Measured: two years
Aneurysm neck size and changes following an invasive procedure to repair it (EVAR).
Measured: two years
Evaluation of the pressure on the aneurysmal wall.
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2016 (estimated)
- Study startApr 2016
- Primary completionApr 2018 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Aortic Aneurysm, AbdominalStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Diana Gaitini, MD, Prof., Principal investigator, Director of Ultrasound Unit, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02717481
- Sponsor's protocol ID
- 0551-15 RMB CTIL
- Status last verified
- Mar 2016
- First submitted
- 13 Mar 2016
- Last updated
- 23 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: undecided
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.
PubMed 21911788McNally 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.
PubMed 25175634Pfister 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.
PubMed 26484714
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Ultrasound to Evaluate Aortic Aneurysm Size Based on 3D Co-registration to Previous Computerized Tomography
- ClinicalTrials.gov ID
- NCT02717481
- Acronym / sponsor ID
- 0551-15 RMB CTIL
- Conditions
- Aortic Aneurysm, Abdominal
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 23 Mar 2016 (estimated)
- 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.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with known aortic aneurysm | – | Device: US-CT Fusion examinationPatients with known abdominal aortic aneurysm diagnosed in clinical follow-up or after an invasive procedure to repair it. US-CT Fusion examination |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with abdominal aortic aneurysm diagnosis in clinical follow-up or after an invasive procedure to fix it
Key inclusion criteria (1 listed)
- •Patients with abdominal aortic aneurysm diagnosis in clinical follow-up or after an invasive procedure to fix it.
Key exclusion criteria (5 listed)
- Inability to perform Ultrasound
- Pace maker
- Hemodynamic instability
- Inability to cooperate in US examination
- Pregnant Women - does not undergo CT
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 |
|---|---|---|
| US-CT Fusion examinationPatients will undergo an US examination using an US device with US-CT Fusion capabilities. | Device | Patients with known aortic aneurysm |
Primary outcome
Exact and reliable evaluation of the aneurysm size
Time frame: two years
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.
3 secondary outcomes
The size difference between systolic and diastolic aneurysm.
Time frame: two years
Aneurysm neck size and changes following an invasive procedure to repair it (EVAR).
Time frame: two years
Evaluation of the pressure on the aneurysmal wall.
Time frame: two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2016.
- Background: PubMed 21911788Kobeiter 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.
- Background: PubMed 25175634McNally 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.
- Background: PubMed 26484714Pfister 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.
- Individual participant dataSharing planned: Undecided. undecided
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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.
Diana Gaitini, MD, Prof. principal investigator
Director of Ultrasound Unit, Rambam Health Care Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Aneurysm, Abdominal, run by Rambam Health Care Campus at 1 site in Israel.
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 5 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: status not confirmed, as of the sponsor's last update on 23 Mar 2016. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Diana Gaitini, MD, Prof. (+972-4-7773675, d_gaitini@rambam.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exact and reliable evaluation of the aneurysm size (time frame: two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02717481, which also lists 3 linked publications.
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 23 Mar 2016.