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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT01851161
First received: April 26, 2013
Last updated: May 15, 2015
Last verified: May 2015
  Purpose

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.


Condition Intervention
Lung Cancer
Procedure: computed tomography
Procedure: 4-dimensional computed tomography
Radiation: radiation therapy

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Pulmonary Tumor Motion Reduction and Improved Breathing Reproducibility by Prone Patient Positioning in Radiation Therapy

Resource links provided by NLM:


Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • Motion of the tumor and normal tissue evaluated in reference to the bony anatomy (vertebra) [ Time Frame: up to 90 days ] [ Designated as safety issue: No ]
    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.


Enrollment: 23
Study Start Date: May 2010
Estimated Study Completion Date: July 2015
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Procedure: computed tomography
Undergo conventional CT scan in both supine and prone positioning
Other Name: tomography, computed
Procedure: 4-dimensional computed tomography
Undergo 4D CT scan in both supine and prone positioning
Other Name: 4D-CT
Radiation: radiation therapy
Undergo radiation therapy
Other Name: irradiation, radiotherapy, therapy, radiation

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01851161

Locations
United States, Virginia
Virginia Commonwealth University, Massey Cancer Center
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
Principal Investigator: Mihaela Rosu, Ph.D. Virginia Commonwealth University
  More Information

No publications provided

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01851161     History of Changes
Other Study ID Numbers: MCC-12806, NCI-2013-00848, HM12806
Study First Received: April 26, 2013
Last Updated: May 15, 2015
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 21, 2015