Development of Ultra-Low Dose CT Based Screening for Aortic Aneurysms

Study Overview
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Brief Summary
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The primary objective of this research project is development and validation of a new, non-contrast gated aortic (NCGA) computer tomography scan algorithm for screening of aortic aneurysm in the chest and abdomen in at risk patients. This study would initially be performed in patients with a known aneurysm and done in addition to their indicated surveillance CT scan.

Detailed Description
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Study Design: Patients who agree to enroll in the study will get the NCGA study as well as a routine non-contrast computed tomography of chest/abdomen/pelvis within one year following recruitment at the patient's convenience. No follow-up will be required, but any clinically relevant findings on the testing will be communicated to the PCP through EPIC in-basket. Urgent findings, as determined by the primary investigator, will also result in a direct communication with the PCP. It is expected that any such findings will also be seen on the standard and clinically indicated CT which they are also undergoing, and so new or unique findings on the study NCGA test are not expected to occur. The final study visit will be the day of participation. Study Design: Patients who agree to enroll in the study will get the NCGA study as well as a routine non-contrast computed tomography of chest/abdomen/pelvis within one year following recruitment at the patient's convenience. No follow-up will be required, but any clinically relevant findings on the testing will be communicated to the PCP through EPIC in-basket. Urgent findings, as determined by the primary investigator, will also result in a direct communication with the PCP. It is expected that any such findings will also be seen on the standard and clinically indicated CT which they are also undergoing, and so new or unique findings on the study NCGA test are not expected to occur. The final study visit will be the day of participation. Study Procedures: One visit to complete one (1) non-contrast (no dye/contrast material will be injected) computed tomography (CT) scan of the chest, abdomen and pelvis. This visit will occur within one year following recruitment, scheduled at the patient's convenience. This one visit represents the totality of study participation for each participant. Study Duration: For each individual, participation is only over one day - the day of the patient's non-contrast CT scan. No early termination visits or unscheduled visits apply. The anticipated duration to complete enrollment of all participants is 1 year. Following completion of the study, the study team is planning for an interim period of 6 months for discussion and planning for future projects.

Official Title
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Development of Ultra-Low Dose CT Based Screening for Aortic Aneurysms

Conditions
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Aortic Aneurysm, Thoracic, Aortic Aneurysm, Abdominal

Intervention / Treatment
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* Other: Ultra Low-Dose CT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients who carry the diagnosis of thoracic aortic aneurysm, aortic dissection, or abdominal aortic aneurysm and require CT imaging to evaluate the pathology Exclusion Criteria: Current pregnancy
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ultra Low-Dose CT<br>One non-contrast gated aortic (NCGA) computer tomography scan, a low radiation, non-contrast, low cost CT based study | Other: Ultra Low-Dose CT<br>* Ultra Low-Dose CT<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of Ultra Low-Dose CT | To assess the sensitivity of NCGA for aortic aneurysm in the thoracic or abdominal aorta | Day of Scan | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiation Exposure of Ultra Low-Dose CT | To assess the relative radiation exposure of NCGA to the patient in comparison to a standard CT | Day of Scan |