CT in Diagnosing Patients With Lung Cancer
Primary Purpose
Lung Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
computed tomography
4-dimensional computed tomography
computed tomography
cone-beam computed tomography
cone-beam computed tomography
Sponsored by
About this trial
This is an interventional diagnostic trial for Lung Cancer
Eligibility 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
Sites / Locations
- Virginia Commonwealth University/Massey Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Diagnostic (imaging studies)
Arm Description
Patients undergo conventional free breathing CT, 4D CT, ABC CT, ABC CBCT, and free breathing CBCT before undergoing radiation therapy.
Outcomes
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
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
A two sided t-test with 5% level of significance will be used.
Dosimetric changes related to contouring variations for tumor and normal tissue
A two sided t-test with 5% level of significance will be used.
Full Information
NCT ID
NCT01888510
First Posted
June 25, 2013
Last Updated
July 6, 2016
Sponsor
Virginia Commonwealth University
1. Study Identification
Unique Protocol Identification Number
NCT01888510
Brief Title
CT in Diagnosing Patients With Lung Cancer
Official Title
Comparison of Conventional Free Breathing CT, 4D CT, and Integrated Active Breath Hold CT Image Acquisition for Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Diagnostic (imaging studies)
Arm Type
Experimental
Arm Description
Patients undergo conventional free breathing CT, 4D CT, ABC CT, ABC CBCT, and free breathing CBCT before undergoing radiation therapy.
Intervention Type
Procedure
Intervention Name(s)
computed tomography
Other Intervention Name(s)
tomography, computed
Intervention Description
Undergo conventional free breathing CT
Intervention Type
Procedure
Intervention Name(s)
4-dimensional computed tomography
Other Intervention Name(s)
4D-CT
Intervention Description
Undergo 4D CT
Intervention Type
Procedure
Intervention Name(s)
computed tomography
Other Intervention Name(s)
tomography, computed
Intervention Description
Undergo ABC CT
Intervention Type
Procedure
Intervention Name(s)
cone-beam computed tomography
Intervention Description
Undergo ABC CBCT
Intervention Type
Procedure
Intervention Name(s)
cone-beam computed tomography
Intervention Description
Undergo free breathing CBCT
Primary Outcome Measure Information:
Title
Amount of inter- and intra-physician contouring variability on 4D CT, ABC CT, free breathing CT, and free breathing and ABC CBCT
Description
A two sided t-test with 5% level of significance will be used.
Time Frame
up to 1 week
Secondary Outcome Measure Information:
Title
Magnitude and distribution of target and organ at risk volume variations between the different imaging modalities
Description
A two sided t-test with 5% level of significance will be used.
Time Frame
up to 1 week
Title
Dosimetric changes related to contouring variations for tumor and normal tissue
Description
A two sided t-test with 5% level of significance will be used.
Time Frame
up to 1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Weiss, M.D.
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University/Massey Cancer Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
12. IPD Sharing Statement
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CT in Diagnosing Patients With Lung Cancer
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