NCT01979991

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
184

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Aug 2010

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

November 1, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 8, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

February 5, 2016

Status Verified

February 1, 2016

Enrollment Period

4.6 years

First QC Date

November 1, 2013

Last Update Submit

February 3, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

CT Imaging and Reconstruction

EXPERIMENTAL

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

Procedure: CT Imaging and Reconstruction

Interventions

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.

CT Imaging and Reconstruction

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan Hospital

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Lung Diseases

Interventions

Plastic Surgery Procedures

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

  • Jeffrey Fessler, PhD

    University of Michigan Hospital

    PRINCIPAL INVESTIGATOR
  • Jeffrey Fessler, PhD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 1, 2013

First Posted

November 8, 2013

Study Start

August 1, 2010

Primary Completion

March 1, 2015

Study Completion

December 1, 2015

Last Updated

February 5, 2016

Record last verified: 2016-02

Locations