Prospective Evaluation of Next Generation CT Reconstruction (NextGenIR)

Prospective Evaluation of Next Generation CT Reconstruction

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy Subjects

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 Type: Observational
• Enrollment (Estimated): 215

Contacts and Locations

• Study Contact: Name: Margaret C Lowery, R.N.; Phone Number: (301) 451-3128; Email: peg.lowery@nih.gov
• Study Contact Backup: Name: Marcus Y Chen, M.D.; Phone Number: (301) 496-0077; Email: chenmy@mail.nih.gov

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20892
      • Recruiting
      • National Institutes of Health Clinical Center
      • Contact: NIH Clinical Center Office of Patient Recruitment (OPR); Phone Number: TTY dial 711 800-411-1222; Email: ccopr@nih.gov

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 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.

Description

• 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 Plan

How is the study designed?

Design Details

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

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Body CT group; 100 subjects for a body CT
Chest Ct Group; 115 subjects for a chest CT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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)

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): September 8, 2014
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: April 15, 2015
• First Submitted That Met QC Criteria: April 15, 2015
• First Posted (Estimated): April 16, 2015

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 14, 2026
• Last Verified: October 29, 2025

More Information

Terms related to this study

• Keywords: Natural History; Computed Tomography; Radiation Reduction; Iterative Reconstruction
• Other Study ID Numbers: 140188; 14-H-0188

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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