CT in Diagnosing Patients With Lung Cancer

July 6, 2016 updated by: Virginia Commonwealth University

Comparison of Conventional Free Breathing CT, 4D CT, and Integrated Active Breath Hold CT Image Acquisition for Lung Cancer

This clinical trial studies computed tomography (CT) in diagnosing patients with lung cancer. Diagnostic procedures, such as CT, may help find and diagnose lung cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. Conduct a prospective clinical imaging study to quantify the amount of inter- and intra-physician contouring variability on four dimensional (4D) CT, active breathing control (ABC) CT, free breathing CT, and free breathing and ABC cone beam (CB)CT.

II. Quantify the magnitude and distribution of target and organ at risk volume variations between the different imaging modalities.

III. Determine dosimetric changes related to contouring variations for tumor and normal tissue.

OUTLINE:

Patients undergo conventional free breathing CT, 4D CT, ABC CT, ABC CBCT, and free breathing CBCT before undergoing radiation therapy.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University/Massey Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Measurable disease on CT scan
  • Patients with lung cancer visible on CT who are scheduled to receive external beam radiation treatment will be eligible for this study
  • Patients must be able to perform ABC procedures

Exclusion Criteria:

  • Patients requiring continuous supplemental oxygen due to the requirement of spirometry during all imaging studies
  • No vulnerable populations will be enrolled (prisoners, children, pregnant females or institutionalized individuals)
  • Women of childbearing potential will undergo a pregnancy test

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Diagnostic (imaging studies)
Patients undergo conventional free breathing CT, 4D CT, ABC CT, ABC CBCT, and free breathing CBCT before undergoing radiation therapy.
Procedure: computed tomography
Undergo conventional free breathing CT
Other Names:
  • tomography, computed
Procedure: 4-dimensional computed tomography
Undergo 4D CT
Other Names:
  • 4D-CT
Procedure: computed tomography
Undergo ABC CT
Other Names:
  • tomography, computed
Procedure: cone-beam computed tomography
Undergo ABC CBCT
Procedure: cone-beam computed tomography
Undergo free breathing CBCT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Amount of inter- and intra-physician contouring variability on 4D CT, ABC CT, free breathing CT, and free breathing and ABC CBCT
Time Frame: up to 1 week
A two sided t-test with 5% level of significance will be used.
up to 1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Magnitude and distribution of target and organ at risk volume variations between the different imaging modalities
Time Frame: up to 1 week
A two sided t-test with 5% level of significance will be used.
up to 1 week
Dosimetric changes related to contouring variations for tumor and normal tissue
Time Frame: up to 1 week
A two sided t-test with 5% level of significance will be used.
up to 1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Virginia Commonwealth University

Investigators

  • Principal Investigator: Elizabeth Weiss, M.D., Virginia Commonwealth University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

June 25, 2013

First Submitted That Met QC Criteria

June 25, 2013

First Posted (Estimate)

June 27, 2013

Study Record Updates

Last Update Posted (Estimate)

July 7, 2016

Last Update Submitted That Met QC Criteria

July 6, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCC-15032
  • NCI-2013-01163 (Registry Identifier: NCI)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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