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Prospective Evaluation of Next Generation CT Reconstruction (NextGenIR)

National Institutes of Health (NIH) logo

National Institutes of Health (NIH)

Status

Enrolling

Conditions

Healthy Subjects

Study type

Observational

Funder types

NIH

Identifiers

NCT02417714
14-H-0188
140188

Details and patient eligibility

About

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.

Full 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.

Enrollment

215 estimated patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

  • 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

Trial design

215 participants in 2 patient groups

Body CT group
Description:
100 subjects for a body CT
Chest Ct Group
Description:
115 subjects for a chest CT

Trial contacts and locations

1

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Central trial contact

Marcus Y Chen, M.D.; Margaret C Lowery, R.N.

Data sourced from clinicaltrials.gov

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