Lung CancerNCT01851161
Prone Patient Positioning in Reducing Tumor Motion and Improving Breathing Reproduction in Patients With Lung Cancer Undergoing Radiation Therapy
An observational study of Lung Cancer, run by Virginia Commonwealth University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- computed tomography, 4-dimensional computed tomography and radiation therapy
- Type of treatment
- Surgery or procedure
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Sep 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Patients requiring continuous supplemental oxygen due to the requirement of spirometry during all imaging studies
- Pregnant females
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University, Massey Cancer Center
Richmond, Virginia, 23298
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Conditions
- Lung Cancer
- Being tested
- computed tomography, 4-dimensional computed tomography, radiation therapy
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
computed tomographyProcedure or surgery
Also called tomography, computed
Undergo conventional CT scan in both supine and prone positioning
4-dimensional computed tomographyProcedure or surgery
Also called 4D-CT
Undergo 4D CT scan in both supine and prone positioning
radiation therapyRadiation
Also called irradiation, radiotherapy, therapy, radiation
Undergo radiation therapy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: computed tomography; Procedure: 4-dimensional computed tomography; Radiation: radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2013 (estimated)
- Study startMay 2010
- Primary completionApr 2015
- Study completionSep 2015
Why it stopped: Data analysis completed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mihaela Rosu, Ph.D., Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01851161
- Sponsor's protocol ID
- MCC-12806
- Other IDs
- NCI-2013-00848, HM12806
- Status last verified
- Sep 2015
- First submitted
- 26 Apr 2013
- Last updated
- 18 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Tumor Motion Reduction and Improved Breathing Reproducibility by Prone Patient Positioning in Radiation Therapy
- ClinicalTrials.gov ID
- NCT01851161
- Acronym / sponsor ID
- MCC-12806
- Conditions
- Lung Cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Data analysis completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Apr 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 10 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (CT and 4D CT in supine and prone positioning) | – | Procedure: computed tomography, Procedure: 4-dimensional computed tomography, Radiation: radiation therapyPatients undergo conventional CT scan and 4D CT scan in both supine and prone positioning before undergoing radiation therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Patients requiring continuous supplemental oxygen due to the requirement of spirometry during all imaging studies
- Pregnant females
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| computed tomographyAlso: tomography, computedUndergo conventional CT scan in both supine and prone positioning | Procedure or surgery | Diagnostic (CT and 4D CT in supine and prone positioning) |
| 4-dimensional computed tomographyAlso: 4D-CTUndergo 4D CT scan in both supine and prone positioning | Procedure or surgery | Diagnostic (CT and 4D CT in supine and prone positioning) |
| radiation therapyAlso: irradiation, radiotherapy, therapy, radiationUndergo radiation therapy | Radiation | Diagnostic (CT and 4D CT in supine and prone positioning) |
Primary outcome
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.
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.
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.
Results and safety
The study was stopped early (reason given: Data analysis completed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mihaela Rosu, Ph.D. principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Data analysis completed). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary 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 (time frame: up to 90 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2015.