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

Terminated

• Conditions: Lung Cancer
• Interventions: Procedure: computed tomography; Procedure: 4-dimensional computed tomography; Radiation: radiation therapy

• Registration Number: NCT01851161
• Lead Sponsor: Virginia Commonwealth University

Brief Summary

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.

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 Timeline

• Study Start: 2010-05
• Study First Submitted: 2013-04-26
• Study First Submitted QC: 2013-05-07
• Study First Posted: 2013-05-10
• Primary Completion: 2015-04
• Status Verified: 2015-09
• Study Completion: 2015-09
• Last Update Submitted: 2015-09-16
• Last Update Posted: 2015-09-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 23

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Diagnostic (CT and 4D CT in supine and prone positioning)	computed tomography	Patients undergo conventional CT scan and 4D CT scan in both supine and prone positioning before undergoing radiation therapy.
Diagnostic (CT and 4D CT in supine and prone positioning)	4-dimensional computed tomography	Patients undergo conventional CT scan and 4D CT scan in both supine and prone positioning before undergoing radiation therapy.
Diagnostic (CT and 4D CT in supine and prone positioning)	radiation therapy	Patients undergo conventional CT scan and 4D CT scan in both supine and prone positioning before undergoing radiation therapy.

Primary Outcome Measures

Name	Time	Method
Motion of the tumor and normal tissue evaluated in reference to the bony anatomy (vertebra)	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.
Consistency of the respiratory pattern, quantified by the cycle-to-cycle variation in the respiration trace during imaging in prone vs. supine positioning	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.
Consistency of the respiratory pattern, quantified by the cycle-to-cycle variation in the respiration trace during a radiotherapy series	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.

Trial Locations

Locations (1)

Virginia Commonwealth University, Massey Cancer Center; 🇺🇸 Richmond, Virginia, United States