CT in Diagnosing Patients With Lung Cancer

Not Applicable

Completed

• Conditions: Lung Cancer
• Interventions: Procedure: computed tomography; Procedure: 4-dimensional computed tomography; Procedure: cone-beam computed tomography

• Registration Number: NCT01888510
• Lead Sponsor: Virginia Commonwealth University

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.

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-06-25
• Study First Submitted QC: 2013-06-25
• Study First Posted: 2013-06-27
• Primary Completion: 2016-05
• Study Completion: 2016-06
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-06
• Last Update Posted: 2016-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic (imaging studies)	4-dimensional computed tomography	Patients undergo conventional free breathing CT, 4D CT, ABC CT, ABC CBCT, and free breathing CBCT before undergoing radiation therapy.
Diagnostic (imaging studies)	cone-beam computed tomography	Patients undergo conventional free breathing CT, 4D CT, ABC CT, ABC CBCT, and free breathing CBCT before undergoing radiation therapy.
Diagnostic (imaging studies)	computed tomography	Patients undergo conventional free breathing CT, 4D CT, ABC CT, ABC CBCT, and free breathing CBCT before undergoing radiation therapy.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Magnitude and distribution of target and organ at risk volume variations between the different imaging modalities	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	up to 1 week	A two sided t-test with 5% level of significance will be used.

Trial Locations

Locations (1)

Virginia Commonwealth University/Massey Cancer Center; 🇺🇸 Richmond, Virginia, United States