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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
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lung Cancer

Eligibility Criteria

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

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

First Posted
June 25, 2013
Last Updated
July 6, 2016
Sponsor
Virginia Commonwealth University
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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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