Prospective Evaluation of Next Generation CT Reconstruction (NextGenIR)

Healthy Subjects Clinical Trial

Official title:

Prospective Evaluation of Next Generation CT Reconstruction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02417714
• Other study ID #: 140188
• Secondary ID: 14-H-0188
• Status: Recruiting
• Start date: September 8, 2014
• Est. completion date: July 1, 2025

Study information

• Verified date: December 15, 2023
• Source: National Institutes of Health Clinical Center (CC)
• Contact: Margaret C Lowery, R.N.
• Phone: (301) 451-3128
• Email: peg.lowery[@]nih.gov
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 215
• Est. completion date: July 1, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

• 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

Related Conditions & MeSH terms

• Healthy Subjects

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Baseline (Day 0)

External Links

•   NIH Clinical Center Detailed Web Page