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

Primary Purpose

Aortic Aneurysm, Thoracic, Aortic Aneurysm, Abdominal

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ultra Low-Dose CT
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Aortic Aneurysm, Thoracic

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Minnesota - Twin Cities

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ultra Low-Dose CT

Arm Description

One non-contrast gated aortic (NCGA) computer tomography scan, a low radiation, non-contrast, low cost CT based study

Outcomes

Primary Outcome Measures

Effectiveness of Ultra Low-Dose CT
To assess the sensitivity of NCGA for aortic aneurysm in the thoracic or abdominal aorta

Secondary Outcome Measures

Radiation Exposure of Ultra Low-Dose CT
To assess the relative radiation exposure of NCGA to the patient in comparison to a standard CT

Full Information

First Posted
March 7, 2018
Last Updated
July 15, 2019
Sponsor
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT03479164
Brief Title
Development of Ultra-Low Dose CT Based Screening for Aortic Aneurysms
Official Title
Development of Ultra-Low Dose CT Based Screening for Aortic Aneurysms
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
March 30, 2016 (Actual)
Primary Completion Date
June 30, 2018 (Actual)
Study Completion Date
July 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Aneurysm, Thoracic, Aortic Aneurysm, Abdominal

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ultra Low-Dose CT
Arm Type
Experimental
Arm Description
One non-contrast gated aortic (NCGA) computer tomography scan, a low radiation, non-contrast, low cost CT based study
Intervention Type
Other
Intervention Name(s)
Ultra Low-Dose CT
Intervention Description
Ultra Low-Dose CT
Primary Outcome Measure Information:
Title
Effectiveness of Ultra Low-Dose CT
Description
To assess the sensitivity of NCGA for aortic aneurysm in the thoracic or abdominal aorta
Time Frame
Day of Scan
Secondary Outcome Measure Information:
Title
Radiation Exposure of Ultra Low-Dose CT
Description
To assess the relative radiation exposure of NCGA to the patient in comparison to a standard CT
Time Frame
Day of Scan
Other Pre-specified Outcome Measures:
Title
Assess Findings of Ultra Low-Dose CT
Description
To assess the success of limiting extraneous findings of the test.
Time Frame
Day of Scan
Title
Optimize Automation of Ultra Low-Dose CT
Description
To optimize automation of the test.
Time Frame
Day of Scan

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rumi Faizer, MD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota - Twin Cities
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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