High Image Matrix CT Reconstruction

Sponsor
National Heart, Lung, and Blood Institute (NHLBI) (NIH)
Overall Status
Completed
CT.gov ID
NCT02610465
Collaborator
(none)
148
1
52.6
2.8

Study Details

Study Description

Brief Summary

Background:

Computed Tomography (CT) scans make detailed pictures of the body in seconds. CT scans make pictures by passing x-rays through a person. CT scans are common. In 2011, around 85.3 million of them occurred in the United States. Researchers think CT images can be made better using new techniques. Higher resolution images can be derived from the original scan.

Objective:

To learn if new ways of obtaining and processing pictures of the body from a regular CT scan can produce images with higher resolution (pixels) and more information than standard methods.

Eligibility:

People ages 18 and older who are scheduled to have a CT scan and are not pregnant

Design:

Participants will be screened with a review of their medical records.

Participants will have their scheduled CT scan.

The CT scanner used in this study provides enhanced images of inside the body. Researchers may use the CT scanner in a research mode to test and improve the pictures.

Images from the CT scan will be reviewed.

Any clinical findings from the CT test will be shared with the participant s doctor.

Participants will continue to receive their medical care from their regular doctor.

The CT images will be entered into an NIH research database. In the future, they may be used for research purposes.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Computed Tomography (CT) images the body. Different methods of creating CT pictures are avilable on a research basis that enables higher resolution imaging using the same aquisition. The purpose of this research study is to learn wheteher these new high resolution images derived from the original CT scan provide similar or perhaps more information than the current standard clinical method.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    148 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    High Image Matrix CT Reconstruction
    Actual Study Start Date :
    Nov 9, 2015
    Actual Primary Completion Date :
    Mar 27, 2020
    Actual Study Completion Date :
    Mar 27, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    1

    Computed Tomography (CT) images

    Outcome Measures

    Primary Outcome Measures

    1. Compare with respect to 7 image quality metrics the overall image quality from a higher resolution CT with traditional clinical standard CT from the same acquisition [05/13/2016]

      The primary analysis will compare the overall image quality across the 7 Likert scales between the clinical standard and the high resolution images. For each of the two readers, we will sum each subject s 7 Likert scores for the standard and high resolution images, respectively. Then we will average the two readers standard image cumulative scores, respectively, the two readers high resolution image cumulative scores. Thus for each subject, both the standard and high resolution images will have an average cumulative score between 7 and 34. For each subject, we will compute the difference between the standard image and high resolution image average cumulative scores. The primary analysis will report the mean and its 95% confidence interval for the standard image high resolution image difference. We will also report the median and 5th-95th percentiles of the differences.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    • INCLUSION CRITERIA:

    • Clinical indication for CT

    • Age equal to or greater than 18 years

    • Able to understand and willing to sign the Informed Consent Form

    EXCLUSION CRITERIA:

    -Pregnancy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Institutes of Health Clinical Center, 9000 Rockville Pike Bethesda Maryland United States 20892

    Sponsors and Collaborators

    • National Heart, Lung, and Blood Institute (NHLBI)

    Investigators

    • Principal Investigator: Marcus Y Chen, M.D., National Heart, Lung, and Blood Institute (NHLBI)

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    National Heart, Lung, and Blood Institute (NHLBI)
    ClinicalTrials.gov Identifier:
    NCT02610465
    Other Study ID Numbers:
    • 160019
    • 16-H-0019
    First Posted:
    Nov 20, 2015
    Last Update Posted:
    Aug 25, 2022
    Last Verified:
    Jun 10, 2022
    Keywords provided by National Heart, Lung, and Blood Institute (NHLBI)
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 25, 2022