Clinical trial NCT02417714: Prospective Evaluation of Next Generation CT Reconstruction (NextGenIR)
Official title: Prospective Evaluation of Next Generation CT Reconstruction
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Healthy Subjects
Keywords: Computed Tomography
Radiation Reduction
Iterative Reconstruction
Natural History
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2015-04-16
Enrollment: 215
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be enrolled at the NIH Clinical Center. A total of 200 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.

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.

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.

Eligibility 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

Primary outcomes:
measure: Compare with respect to 7 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
timeFrame: Baseline (Day 0)
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center
state: Maryland
Study officials:
affiliation: National Heart, Lung, and Blood Institute (NHLBI)
name: Marcus Y Chen, M.D.
role: PRINCIPAL_INVESTIGATOR
References: