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


N/A
18 Years
N/A
Open (Enrolling)
Both
Lung Cancer

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Amount of inter- and intra-physician contouring variability on 4D CT, ABC CT, free breathing CT, and free breathing and ABC CBCT

Outcome Description:

A two sided t-test with 5% level of significance will be used.

Outcome Time Frame:

up to 1 week

Safety Issue:

No

Principal Investigator

Elizabeth Weiss, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Virginia Commonwealth University

Authority:

United States: Institutional Review Board

Study ID:

MCC-015032

NCT ID:

NCT01888510

Start Date:

May 2013

Completion Date:

February 2016

Related Keywords:

  • Lung Cancer
  • Lung Neoplasms

Name

Location
Virginia Commonwealth University/Massey Cancer Center Richmond, Virginia  23298