Prone Patient Positioning in Reducing Tumor Motion and Improving Breathing Reproduction in Patients With Lung Cancer Undergoing Radiation Therapy

September 16, 2015 updated by: Virginia Commonwealth University

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

This clinical trial studies prone patient positioning in reducing tumor motion and improving breathing reproduction in patients with lung cancer undergoing radiation therapy. Prone patient positioning during radiation therapy may help kill tumor cells without harming normal tissue.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

23

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University, Massey Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

General radiotherapy patient population during either the consultation or the simulation process. The possible participant will be contacted by either of the investigators or the study coordinator. Eligibility will be evaluated by observing the simulation data collected for each patient clinically, including any pretreatment fluoroscopy, digital simulation radiographs, cone beam CT, conventional or four-dimensional CT scans. Only clinical data will be used to assess eligibility. No extra imaging will be performed on a patient solely for the purpose of assessing eligibility.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Diagnostic (CT and 4D CT in supine and prone positioning)
Patients undergo conventional CT scan and 4D CT scan in both supine and prone positioning before undergoing radiation therapy.
Radiation: radiation therapy
Undergo radiation therapy
Other Names:
  • irradiation, radiotherapy, therapy, radiation
Procedure: computed tomography
Undergo conventional CT scan in both supine and prone positioning
Other Names:
  • tomography, computed
Procedure: 4-dimensional computed tomography
Undergo 4D CT scan in both supine and prone positioning
Other Names:
  • 4D-CT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Consistency of the respiratory pattern, quantified by the cycle-to-cycle variation in the respiration trace during imaging in prone vs. supine positioning
Time Frame: up to 90 days
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.
up to 90 days
Consistency of the respiratory pattern, quantified by the cycle-to-cycle variation in the respiration trace during a radiotherapy series
Time Frame: up to 90 days
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.
up to 90 days
Motion of the tumor and normal tissue evaluated in reference to the bony anatomy (vertebra)
Time Frame: up to 90 days
The prone and supine image data acquired before the treatment onset will be used for planning. The computation of the doses will be performed on the dataset corresponding to the average position over the breathing pattern, based on previous studies indicating that a dose computation on this dataset approximates with sufficient accuracy the dose that will be received by the patient. The distributions of the tumor and normal tissue volumes in the prone and supine scans will be derived and the volume consistency will be assessed using the mean and the standard deviation of these distributions.
up to 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Virginia Commonwealth University

Investigators

  • Principal Investigator: Mihaela Rosu, Ph.D., Virginia Commonwealth University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

April 26, 2013

First Submitted That Met QC Criteria

May 7, 2013

First Posted (Estimate)

May 10, 2013

Study Record Updates

Last Update Posted (Estimate)

September 18, 2015

Last Update Submitted That Met QC Criteria

September 16, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCC-12806
  • NCI-2013-00848 (Registry Identifier: NCI)
  • HM12806 (Other Identifier: Virginia Commonwealth University IRB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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