Prospective Evaluation of Next Generation CT Reconstruction (NextGenIR)

NCT02417714 | Recruiting

• 2 other identifiers: 14018814-H-0188
• Study Type: observational
• Target: 215
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Subjects

Keywords

Computed Tomography; Radiation Reduction; Iterative Reconstruction; Natural History

Outcome Measures

Primary Outcomes (1)

• Compare with respect to 6 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)

Study Arms (2)

Body CT group

100 subjects for a body CT

Chest Ct Group

115 subjects for a chest CT

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be enrolled at the NIH Clinical Center. A total of 215 subjects will be enrolled. Subjects will be recruited from the NIH Clinical Center radiology department from subjects scheduled to have a CT scan of the chest, abdomen and pelvis with contrast.

You may qualify if:

• Clinical indication for a chest, abdomen and pelvis CT with contrast
• Age equal to or greater than 18 years
• Able to understand and willing to sign the Informed Consent Form
• Clinical indication for a CT with or without contrast that includes the chest
• 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
• Serum Cr \> 1.5 mg/dL
• Clinical CT scan with more than one contrast imaging phase (for example three phase liver)
• \. Pregnancy

Sponsors & Collaborators

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

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Links

• NIH Clinical Center Detailed Web Page

Study Officials

• Marcus Y Chen, M.D.

  National Heart, Lung, and Blood Institute (NHLBI)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Margaret C Lowery, R.N.

CONTACT

(301) 451-3128; peg.lowery@nih.gov

Marcus Y Chen, M.D.

CONTACT

(301) 496-0077; chenmy@mail.nih.gov

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2015
• First Posted: April 16, 2015
• Study Start: September 8, 2014
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: February 17, 2026

Record last verified: 2025-10-29

Locations

US (1)