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Prospective Evaluation of Next Generation CT Reconstruction (NextGenIR)

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ClinicalTrials.gov Identifier: NCT02417714
Recruitment Status : Recruiting
First Posted : April 16, 2015
Last Update Posted : May 22, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )

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.

Condition or disease
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.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prospective Evaluation of Next Generation CT Reconstruction
Actual Study Start Date : September 3, 2014
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : July 1, 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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 [ Time Frame: Same day ]
    Compare with respect to 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02417714


Contacts
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Contact: Margaret C Lowery, R.N. (301) 496-0033 peg.lowery@nih.gov
Contact: Marcus Y Chen, M.D. (301) 496-0077 chenmy@mail.nih.gov

Locations
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United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010    prpl@cc.nih.gov   
Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Marcus Y Chen, M.D. National Heart, Lung, and Blood Institute (NHLBI)

Additional Information:
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Responsible Party: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT02417714     History of Changes
Other Study ID Numbers: 140188
14-H-0188
First Posted: April 16, 2015    Key Record Dates
Last Update Posted: May 22, 2019
Last Verified: May 16, 2019
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) ):
Computed Tomography
Radiation Reduction
Iterative Reconstruction