Prospective Evaluation of Next Generation CT Reconstruction (NextGenIR)

Sponsor
National Heart, Lung, and Blood Institute (NHLBI) (NIH)
Overall Status
Recruiting
CT.gov ID
NCT02417714
Collaborator
(none)
200
1
129.7
1.5

Study Details

Study Description

Brief Summary

Background:
  • Computed Tomography (CT) is a scan that makes detailed pictures of the body. It uses radiation to do that. In 2011, about 85.3 million CT scans were done in the United States. But there is growing concern about the health effects of radiation. There are new and different ways to make CT pictures that use less radiation. Researchers want to learn whether these new methods create images that are similar to images from a traditional CT.
Objective:
  • To learn if new CT imaging methods with less radiation make images that are similar to traditional ways.
Eligibility:
  • Adults 18 years of age and older who are scheduled for a CT of the chest, abdomen and pelvis with contrast.
Design:
  • Researchers will review participants medical records to see if they can be in this study.

  • Participants may have blood drawn from an arm vein by a needle stick. The blood will be used to make sure they can be in this study and that it is safe for them to have contrast.

  • During the participants CT scan appointment, one extra scan will be done using low radiation methods.

  • During a CT scan, the participant lies on a table. A large x-ray machine takes pictures of the body.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Computed Tomography uses ionizing radiation to make pictures of the body. Different methods of creating CT pictures have been developed that allow reductions in the amount of radiation. The purpose of this research study is to learn whether these new imaging methods using less radiation to create images are similar to the traditional and current method.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Prospective Evaluation of Next Generation CT Reconstruction
    Actual Study Start Date :
    Sep 8, 2014
    Anticipated Primary Completion Date :
    Jun 30, 2025
    Anticipated Study Completion Date :
    Jul 1, 2025

    Arms and Interventions

    Arm Intervention/Treatment
    Body CT group

    100 subjects for a body CT

    Chest Ct Group

    100 subjects for a chest CT

    Outcome Measures

    Primary Outcome Measures

    1. Compare with respect to 7 image quality metrics the overall image quality from a research low radiation dose body CT utilizing advanced (model based) iterative reconstruction with a clinical standard radiation dose CT from the same subject [Baseline (Day 0)]

      Compare with respect to image quality metrics, the overall image quality from a research low radiation dose body CT utilizing advanced(model based) iterative reconstruction with a clinical standard radiation dose CT from the same subject.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    • INCLUSION CRITERIA:
    Inclusion Criteria for Body CT:
    1. Clinical indication for a chest, abdomen and pelvis CT with contrast

    2. Age equal to or greater than 18 years

    3. Able to understand and willing to sign the Informed Consent Form

    Inclusion Criteria for Chest CT:
    1. Clinical indication for a CT with or without contrast that includes the chest

    2. Age equal to or greater than 18 years

    3. Able to understand and willing to sign the Informed Consent Form

    EXCLUSION CRITERIA:
    Exclusion Criteria for Body CT:
    1. Pregnancy

    2. Serum Cr > 1.5 mg/dL

    3. Clinical CT scan with more than one contrast imaging phase (for example three phase liver)

    Exclusion Criteria for Chest CT

    1. 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:
    NCT02417714
    Other Study ID Numbers:
    • 140188
    • 14-H-0188
    First Posted:
    Apr 16, 2015
    Last Update Posted:
    Jul 7, 2022
    Last Verified:
    Feb 23, 2022
    Keywords provided by National Heart, Lung, and Blood Institute (NHLBI)

    Study Results

    No Results Posted as of Jul 7, 2022