Prospective Evaluation of Next Generation CT Reconstruction (NextGenIR)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorNational Heart, Lung, and Blood Institute (NHLBI)

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Pregnancy

Serum Cr > 1.5 mg/dL

Clinical CT scan with more than one contrast imaging phase (for example three phase liver)

Trial 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.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

215 Participants
are grouped into 2 trial groups
Group A: Body CT group
Group B: Chest Ct Group

Trial outcomes

Primary outcomes

1

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)

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.