Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03479164
Recruitment Status : Completed
First Posted : March 27, 2018
Last Update Posted : July 16, 2019
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

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.

Layout table for study information
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

Resource links provided by the National Library of Medicine


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




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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03479164


Locations
Layout table for location information
United States, Minnesota
University of Minnesota - Twin Cities
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota
Investigators
Layout table for investigator information
Principal Investigator: Rumi Faizer, MD University of Minnesota
Layout table for additonal information
Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT03479164    
Other Study ID Numbers: 1510M79442
First Posted: March 27, 2018    Key Record Dates
Last Update Posted: July 16, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Aortic Aneurysm, Thoracic
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases