Skip to main content
OpenTrials
Completed

NCT Number: NCT03479164

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota - Twin Cities

Minneapolis, Minnesota, 55455, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultra Low-Dose CT

Other

Ultra Low-Dose CT

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Mar 27, 2018
Registry last updated
Jul 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.