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

• ClinicalTrials.gov Identifier: NCT03479164
• Recruitment Status: Completed
• First Posted: March 27, 2018
• Last Update Posted: July 16, 2019
• Sponsor: University of Minnesota
• Information provided by (Responsible Party): University of Minnesota

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Aortic Aneurysm, Thoracic; Aortic Aneurysm, Abdominal	Other: Ultra Low-Dose CT	Not Applicable

Detailed Description:

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Development of Ultra-Low Dose CT Based Screening for Aortic Aneurysms
• Actual Study Start Date: March 30, 2016
• Actual Primary Completion Date: June 30, 2018
• Actual Study Completion Date: July 1, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: Ultra Low-Dose CT; One non-contrast gated aortic (NCGA) computer tomography scan, a low radiation, non-contrast, low cost CT based study	Other: Ultra Low-Dose CT; Ultra Low-Dose CT

Outcome Measures

Primary Outcome Measures :

1. Effectiveness of Ultra Low-Dose CT [ Time Frame: Day of Scan ]
   To assess the sensitivity of NCGA for aortic aneurysm in the thoracic or abdominal aorta

Secondary Outcome Measures :

1. Radiation Exposure of Ultra Low-Dose CT [ Time Frame: Day of Scan ]
   To assess the relative radiation exposure of NCGA to the patient in comparison to a standard CT

Other Outcome Measures:

1. Assess Findings of Ultra Low-Dose CT [ Time Frame: Day of Scan ]
   To assess the success of limiting extraneous findings of the test.
2. Optimize Automation of Ultra Low-Dose CT [ Time Frame: Day of Scan ]
   To optimize automation of the test.

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Minnesota

University of Minnesota - Twin Cities

Minneapolis, Minnesota, United States, 55455

Sponsors and Collaborators

University of Minnesota

Investigators

• Principal Investigator: Rumi Faizer, MD; University of Minnesota

More Information

• Responsible Party: University of Minnesota
• ClinicalTrials.gov Identifier: NCT03479164
• Other Study ID Numbers: 1510M79442
• First Posted: March 27, 2018
• Last Update Posted: July 16, 2019
• Last Verified: July 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal; Aortic Aneurysm, Thoracic; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases