CT in Diagnosing Patients With Lung Cancer

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Lung Cancer

Intervention / Treatment
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* Procedure: computed tomography
* Procedure: 4-dimensional computed tomography
* Procedure: computed tomography
* Procedure: cone-beam computed tomography
* Procedure: cone-beam computed tomography


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 | 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 | 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 | A two sided t-test with 5% level of significance will be used. | up to 1 week |