Prospective Evaluation of Next Generation CT Reconstruction (NextGenIR)

NCT ID: NCT02417714

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

215 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-09-08

Study Completion Date

2026-07-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Healthy Subjects

Keywords

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Computed Tomography Radiation Reduction Iterative Reconstruction Natural History

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Body CT group

100 subjects for a body CT

No interventions assigned to this group

Chest Ct Group

115 subjects for a chest CT

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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


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

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)


1\. Pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marcus Y Chen, M.D.

Role: PRINCIPAL_INVESTIGATOR

National Heart, Lung, and Blood Institute (NHLBI)

Locations

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National Institutes of Health Clinical Center

Bethesda, Maryland, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Margaret C Lowery, R.N.

Role: CONTACT

Phone: (301) 451-3128

Email: [email protected]

Marcus Y Chen, M.D.

Role: CONTACT

Phone: (301) 496-0077

Email: [email protected]

Facility Contacts

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NIH Clinical Center Office of Patient Recruitment (OPR)

Role: primary

Related Links

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Other Identifiers

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14-H-0188

Identifier Type: -

Identifier Source: secondary_id

140188

Identifier Type: -

Identifier Source: org_study_id