Recruiting

NextGenIR

Sponsor:

National Heart, Lung, and Blood Institute (NHLBI)

Code:

NCT02417714

Conditions

Healthy Subjects

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT02417714

Start date

Sep 8, 2014

Status verified date

Oct 29, 2025

Completion date

Sep 22, 2026

Anticipated

Primary completion date

Sep 22, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

  • 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

Study Design

Enrollment

215 participants

Anticipated

Interventions and Outcome Measures

Arms

Body CT group

100 subjects for a body CT

Chest Ct Group

115 subjects for a chest CT

Primary outcome measure

  • 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. [ Time Frame: Baseline (Day 0) ]

Central Contacts and Locations

Central contacts

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

NIH Clinical Center Office of Patient Recruitment (OPR)

800-411-1222ccopr@nih.gov

More Information

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Last update posted

Aug 7, 2026

Last verified

Oct 29, 2025

Keywords

  • Computed Tomography
  • Radiation Reduction
  • Iterative Reconstruction
  • Natural History

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Heart, Lung, and Blood Institute (NHLBI) on 2026-08-07.