Healthy SubjectsNCT02417714
Prospective Evaluation of Next Generation CT Reconstruction (NextGenIR)
An observational study of Healthy Subjects, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Healthy Subjects
- How many people
- 215 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 2014to 22 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Clinical indication for a chest, abdomen and pelvis CT with contrast
- Age equal to or greater than 18 years
- Able to understand and willing to sign the Informed Consent Form
- Clinical indication for a CT with or without contrast that includes the chest
- Age equal to or greater than 18 years
- Able to understand and willing to sign the Informed Consent Form
Who cannot join
- Pregnancy
- Serum Cr > 1.5 mg/dL
- Clinical CT scan with more than one contrast imaging phase (for example three phase liver)
- 1. Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
NIH Clinical Center Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY dial 711, ccopr@nih.gov
About this study
Official title: Prospective Evaluation of Next Generation CT Reconstruction
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.
Read more
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.
Read the 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.
- Conditions
- Healthy Subjects
- Keywords
- Computed Tomography, Radiation Reduction, Iterative Reconstruction, Natural History
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Body CT group | 100 subjects for a body CT | |
| Chest Ct Group | 115 subjects for a chest CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare with respect to 6 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.
Measured: Baseline (Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2015 (estimated)
- Study start8 Sep 2014
- Primary completion22 Sep 2027 (estimated)
- Study completion22 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 215 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Marcus Y Chen, M.D., Principal investigator, National Heart, Lung, and Blood Institute (NHLBI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02417714
- Sponsor's protocol ID
- 140188
- Other IDs
- 14-H-0188
- Status last verified
- 10 Sep 2026
- First submitted
- 15 Apr 2015
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Next Generation CT Reconstruction
- ClinicalTrials.gov ID
- NCT02417714
- Acronym / sponsor ID
- 140188
- Conditions
- Healthy Subjects
- Keywords
- Computed Tomography, Radiation Reduction, Iterative Reconstruction, Natural History
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 215 participants (estimated)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- 8 Sep 2014 (actual)
- Primary completion
- 22 Sep 2027 (estimated)
- Study completion
- 22 Sep 2027 (estimated)
- First posted
- 16 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Body CT group | – | –100 subjects for a body CT |
| Chest Ct Group | – | –115 subjects for a chest CT |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- Clinical indication for a chest, abdomen and pelvis CT with contrast
- Age equal to or greater than 18 years
- Able to understand and willing to sign the Informed Consent Form
- Clinical indication for a CT with or without contrast that includes the chest
- Age equal to or greater than 18 years
Key exclusion criteria (4 listed)
- Pregnancy
- Serum Cr > 1.5 mg/dL
- Clinical CT scan with more than one contrast imaging phase (for example three phase liver)
- 1. Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Compare with respect to 6 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: Baseline (Day 0)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Healthy Subjects
RecruitingObservational study
Development of Magnetic Resonance Imaging Techniques for Studying Mood and Anxiety Disorders
Mood Disorders, Anxiety Disorders
Not yet recruiting
Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection
Healthy Volunteer, Malaria
RecruitingPhase 1
A Single Ascending Dose Study of DTI-117 Given Intramuscularly in Healthy Participants.
Healthy Adult
RecruitingObservational study
Collection of Lung Fluid and Tissue Samples for Research
Leukocyte Disorders, Respiratory Tract Diseases
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marcus Y Chen, M.D. principal investigator
National Heart, Lung, and Blood Institute (NHLBI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Subjects, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Margaret C Lowery, R.N. ((301) 412-9255, peg.lowery@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare with respect to 6 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: Baseline (Day 0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.