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

Aortic Aneurysm, Abdominal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03479164
• Other study ID #: 1510M79442
• Status: Completed
• Phase: N/A
• Start date: March 30, 2016
• Est. completion date: July 1, 2019

Study information

• Verified date: July 2019
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 1, 2019
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal
• Aortic Aneurysm, Thoracic

Intervention

Other:
• Ultra Low-Dose CT
Ultra Low-Dose CT

Locations

Country	Name	City	State
United States	University of Minnesota - Twin Cities	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Assess Findings of Ultra Low-Dose CT	To assess the success of limiting extraneous findings of the test.	Day of Scan
Other	Optimize Automation of Ultra Low-Dose CT	To optimize automation of the test.	Day of Scan
Primary	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	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