CT in Diagnosing Patients With Lung Cancer

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01888510
• Other study ID #: MCC-15032
• Secondary ID: NCI-2013-01163
• Status: Completed
• Phase: N/A
• First received: June 25, 2013
• Last updated: July 6, 2016
• Start date: May 2013
• Est. completion date: June 2016

Study information

• Verified date: July 2016
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Procedure:
• computed tomography
Undergo conventional free breathing CT
• 4-dimensional computed tomography
Undergo 4D CT
• computed tomography
Undergo ABC CT
• cone-beam computed tomography
Undergo ABC CBCT
• cone-beam computed tomography
Undergo free breathing CBCT

Locations

Country	Name	City	State
United States	Virginia Commonwealth University/Massey Cancer Center	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No