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

NCT01851161 | Terminated DMC

• 3 other identifiers: MCC-12806NCI-2013-00848HM12806
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (3)

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

  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

  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)

  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

Study Arms (1)

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; Procedure: 4-dimensional computed tomography; Radiation: radiation therapy

Interventions

computed tomography PROCEDURE

Undergo conventional CT scan in both supine and prone positioning

Also known as: tomography, computed

Diagnostic (CT and 4D CT in supine and prone positioning)

4-dimensional computed tomography PROCEDURE

Undergo 4D CT scan in both supine and prone positioning

Also known as: 4D-CT

Diagnostic (CT and 4D CT in supine and prone positioning)

radiation therapy RADIATION

Undergo radiation therapy

Also known as: irradiation, radiotherapy, therapy, radiation

Diagnostic (CT and 4D CT in supine and prone positioning)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Patients requiring continuous supplemental oxygen due to the requirement of spirometry during all imaging studies
• Pregnant females

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University, Massey Cancer Center

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Radiotherapy; Radiation; Therapeutics

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Physical Phenomena

Study Officials

• Mihaela Rosu, Ph.D.

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2013
• First Posted: May 10, 2013
• Study Start: May 1, 2010
• Primary Completion: April 1, 2015
• Study Completion: September 1, 2015
• Last Updated: September 18, 2015

Record last verified: 2015-09

Locations

US (1)