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

Primary Purpose

Lung Diseases

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

CT Imaging and Reconstruction

About this trial

This is an interventional basic science trial for Lung Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Inability to lie flat on the back with arms raised over the head for 30min.
Metallic implants or metallic devices in the chest or back.
Participation in other research trials involving ionizing radiation

Sites / Locations

University of Michigan Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CT Imaging and Reconstruction

Arm Description

To develop a MBIR (model-based image reconstruction) method that will improve X-ray CT lung imaging by improving image quality and reducing dose.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01979991

First Posted

November 1, 2013

Last Updated

February 3, 2016

Sponsor

University of Michigan

Collaborators

National Institutes of Health (NIH), General Electric

1. Study Identification

Unique Protocol Identification Number

NCT01979991

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2016

Overall Recruitment Status

Completed

Study Start Date

August 2010 (undefined)

Primary Completion Date

March 2015 (Actual)

Study Completion Date

December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Michigan

Collaborators

National Institutes of Health (NIH), General Electric

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Diseases

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

Investigator

Allocation

N/A

Enrollment

184 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CT Imaging and Reconstruction

Arm Type

Experimental

Arm Description

To develop a MBIR (model-based image reconstruction) method that will improve X-ray CT lung imaging by improving image quality and reducing dose.

Intervention Type

Procedure

Intervention Name(s)

CT Imaging and Reconstruction

Intervention Description

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.

Primary Outcome Measure Information:

Title

Developement of a computer program to improve CT image quality

Description

Time Frame

6 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 1. 18 years of age and older 2. No medical or psychiatric condition precluding informed consent - Exclusion Criteria: Inability to lie flat on the back with arms raised over the head for 30min. Metallic implants or metallic devices in the chest or back. Participation in other research trials involving ionizing radiation

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jeffrey Fessler, PhD

Organizational Affiliation

University of Michigan Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jeffrey Fessler, PhD

Organizational Affiliation

University of Michigan

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Michigan Hospital

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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