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Pulmonary Tumor Motion Reduction and Improved Breathing Reproducibility by Prone Patient Positioning in Radiation Therapy


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

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Trial Information

Pulmonary Tumor Motion Reduction and Improved Breathing Reproducibility by Prone Patient Positioning in Radiation Therapy


PRIMARY OBJECTIVES:

I. Quantify the three-dimensional tumor and normal tissue (thoracic and abdominal) motion,
deformation and volume changes with the respiratory cycle during imaging in prone vs. supine
positioning.

II. Quantify the three-dimensional tumor and normal tissue (thoracic and abdominal) motion,
deformation and volume changes with the respiratory cycle and alterations thereof during a
radiotherapy series.

OUTLINE:

Patients undergo one conventional computed tomography (CT) scan and one 4 dimensional CT (4D
CT) scan in both supine and prone positioning before undergoing radiation therapy.


Inclusion Criteria:



- Measurable disease on the planning computed tomography (CT) scan

- Patients with lung cancer visible on fluoroscopic imaging or planning CT who are
scheduled to receive external beam radiation treatment will be eligible for this
study

Exclusion Criteria:

- Patients requiring continuous supplemental oxygen due to the requirement of
spirometry during all imaging studies

- Pregnant females

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Consistency of the respiratory pattern, quantified by the cycle-to-cycle variation in the respiration trace during imaging in prone vs. supine positioning

Outcome Description:

During the 4D CT patient respiration trace will be recorded using the RPM optical tracking device. The average and standard deviation of the amplitude, period, end of inhalation position, and end of exhalation position of the respiration trace will be calculated. Paired t tests and F tests will be used to evaluate differences between these quantities for supine and prone positioning.

Outcome Time Frame:

up to 90 days

Safety Issue:

No

Principal Investigator

Mihaela Rosu, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Virginia Commonwealth University

Authority:

United States: Institutional Review Board

Study ID:

MCC-12806

NCT ID:

NCT01851161

Start Date:

May 2010

Completion Date:

May 2014

Related Keywords:

  • Lung Cancer
  • Lung Neoplasms

Name

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