High Image Matrix CT Reconstruction

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.

Study Overview

• Status: Completed
• Conditions: Healthy Subjects; Pulmonary-Related Conditions; Cardiac-Related Conditions

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 Type: Observational
• Enrollment (Actual): 148

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20892
      • National Institutes of Health Clinical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-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

Description

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
1; Computed Tomography (CT) images

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• NIH Clinical Center Detailed Web Page

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2015
• Primary Completion (Actual): March 27, 2020
• Study Completion (Actual): March 27, 2020

Study Registration Dates

• First Submitted: November 19, 2015
• First Submitted That Met QC Criteria: November 19, 2015
• First Posted (Estimated): November 20, 2015

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2024
• Last Verified: March 28, 2024

More Information

Terms related to this study

• Keywords: Natural History; Computed Tomography; Image Reconstruction; Iterative Reconstruction
• Additional Relevant MeSH Terms: Pathologic Processes; Disease
• Other Study ID Numbers: 160019; 16-H-0019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No