Model-Based Image Reconstruction for X-Ray CT in Lung Imaging

Lung Diseases Clinical Trial

Official title:

Model-Based Image Reconstruction for X-Ray CT in Lung Imaging

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01979991
• Other study ID #: HUM00038447
• Status: Completed
• Phase: Phase 1
• First received: November 1, 2013
• Last updated: February 3, 2016
• Start date: August 2010
• Est. completion date: December 2015

Study information

• Verified date: February 2016
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

To develop a computer program that will improve CT image quality and decrease the amount of x-ray radiation that future patients may be exposed to when they have a CT examination.

Description:

We will be asking patients for their permission to save and use the sinogram from their CT scan. The sinogram will be de-identified and sent to an archive system for storage. It will be exported to a computer for processing using MBIR (model based iterative reconstruction). MBIR (model based iterative reconstruction) is a new method being developed to process CT sinograms. The newly reconstructed images will be reviewed by experts to determine if they are as readable and accurate as CT images created with the software that is currently being used. Sinogram data and the reconstructed images will be shared with collaborating researchers at General Electric Global Research.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 184
• Est. completion date: December 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 18 years of age and older 2. No medical or psychiatric condition precluding informed consent

Exclusion Criteria:

1. Inability to lie flat on the back with arms raised over the head for 30min.

2. Metallic implants or metallic devices in the chest or back.

3. Participation in other research trials involving ionizing radiation

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Lung Diseases

Intervention

Procedure:
• CT Imaging and Reconstruction
Patients will be consented for their permission to save and use the sinogram from their CT chest/lung scan. The sinogram will be de-identified and sent to an archive system for storage. Later it will be exported to a computer for processing using MBIR (model based image reconstruction). The newly processed images will then be read by blinded readers. The quality of the images will be reviewed to determine if they are as readable and accurate as CT images created with the software that is currently being used.

Locations

Country	Name	City	State
United States	University of Michigan Hospital	Ann Arbor	Michigan

Sponsors (3)

Lead Sponsor	Collaborator
University of Michigan	General Electric, National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Developement of a computer program to improve CT image quality	Sinograms will be retrieved by an archive system and processed by MBIR (model-based image reconstruction) methods that we are developing that improve image quality (reduce noise, improve spatial resolution, reduce artifacts). We will evaluate the image quality both quantitatively and qualitatively.; We hope to develop and benchmark methods for algorithm acceleration to enable routine clinical use of MBIR (model-based image reconstruction) methods.	6 years	Yes