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CT in Diagnosing Patients With Lung Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01888510
First Posted: June 27, 2013
Last Update Posted: July 7, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Virginia Commonwealth University
  Purpose
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.

Condition Intervention
Lung Cancer Procedure: computed tomography Procedure: 4-dimensional computed tomography Procedure: cone-beam computed tomography

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Comparison of Conventional Free Breathing CT, 4D CT, and Integrated Active Breath Hold CT Image Acquisition for Lung Cancer

Resource links provided by NLM:


Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.

  • 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.


Enrollment: 10
Study Start Date: May 2013
Study Completion Date: June 2016
Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: tomography, computed
Procedure: 4-dimensional computed tomography
Undergo 4D CT
Other Name: 4D-CT
Procedure: computed tomography
Undergo ABC CT
Other Name: tomography, computed
Procedure: cone-beam computed tomography
Undergo ABC CBCT
Procedure: cone-beam computed tomography
Undergo free breathing CBCT

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01888510


Locations
United States, Virginia
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
Principal Investigator: Elizabeth Weiss, M.D. Virginia Commonwealth University
  More Information

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01888510     History of Changes
Other Study ID Numbers: MCC-15032
NCI-2013-01163 ( Registry Identifier: NCI )
First Submitted: June 25, 2013
First Posted: June 27, 2013
Last Update Posted: July 7, 2016
Last Verified: July 2016

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases