NCT02610465

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
148

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 9, 2015

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

November 19, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 20, 2015

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 27, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 27, 2020

Completed
Last Updated

March 24, 2026

Status Verified

February 19, 2026

Enrollment Period

4.4 years

First QC Date

November 19, 2015

Last Update Submit

March 21, 2026

Conditions

Keywords

Computed TomographyImage ReconstructionIterative ReconstructionNatural History

Outcome Measures

Primary Outcomes (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

    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.

    05/13/2016

Study Arms (1)

1

Computed Tomography (CT) images

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants will be enrolled at the NIH Clinical CenterUp to 500 subjects will be enrolled. Subjects will be recruited from the NIH Clinical Center radiology department from subjects scheduled to have a CT scan

You may qualify if:

  • Clinical indication for CT
  • Age equal to or greater than 18 years
  • Able to understand and willing to sign the Informed Consent Form

You may not qualify if:

  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

Study Officials

  • Marcus Y Chen, M.D.

    National Heart, Lung, and Blood Institute (NHLBI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2015

First Posted

November 20, 2015

Study Start

November 9, 2015

Primary Completion

March 27, 2020

Study Completion

March 27, 2020

Last Updated

March 24, 2026

Record last verified: 2026-02-19

Locations