Prospective Evaluation of Next Generation CT Reconstruction (NextGenIR)

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type

Observational

Phase

Not applicable / not listed

Age range

18 years - 99 years

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

215 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

• 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 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.

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Not reported

Masking

Not reported

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

Study team and timeline

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Study start

Sep 8, 2014 Actual

Primary completion

Sep 22, 2027 Estimated

Study completion

Sep 22, 2027 Estimated

First posted

Apr 16, 2015 Estimated

Last updated

Nov 9, 2026 Actual

Official study contacts