Tumor MotionPhase 2NCT02324530
Evaluation of Continuous Positive Airway Pressure for Tumor Motion Management in Radiotherapy
A Phase 2 study testing Continuous positive airway pressure (CPAP) in people with Tumor Motion and "Continuous Positive Airway Pressure", run by Sheba Medical Center at 1 site in Israel.
Trial summary
This is a clinical study on patients to compare the effects of CPAP on lung volume diaphragm motion, heart position and tumor motion compared to free breathing. Only patients with significant tumor motion of greater than 1 cm amplitude or unfavorable chest wall geometry (heart close to chest wall) identified on… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tumor Motion, "Continuous Positive Airway Pressure", Lung Cancer
- What is being tested?
- Continuous positive airway pressure (CPAP)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2013to Dec 2015
- Phase
- Phase 2
- 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
Who may be able to join
- Lung tumors and nodules with tumor motion greater than 1 cm on standard imaging
- Left sided breast tumors with unfavorable anatomy, viz heart abutting chest wall
- Upper abdominal tumors: Liver and Pancreas with tumor motion greater than 1 cm. (n=10)
Who cannot join
- Under 18 years old
- Inability to sign informed consent
- Pregnancy,
- Mental Illness,
- Not legally competent
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Sheba_Medical_Center
Tel HaShomer, 5262160
About this study
Official title: Evaluation of CPAP (Continuous Positive Airway Pressure) in the Planning of Radiation Treatments for Lung, Upper Abdomen and Left Breast Cancers
This is a clinical study on patients to compare the effects of CPAP on lung volume diaphragm motion, heart position and tumor motion compared to free breathing. Only patients with significant tumor motion of greater than 1 cm amplitude or unfavorable chest wall geometry (heart close to chest wall) identified on standard imaging and simulation will be candidates for the study. Patients will be re- simulated and planned for radiation treatments with CPAP. The radiation plans generated with and without CPAP will be compared to evaluate the impact of CPAP on tumor motion and dose delivered to adjacent critical structures such as the heart and lung.
Read the detailed description
Primary Objectives
- Evaluate effectiveness of CPAP to reproducibly reduce tumor and organ motion during radiation therapy treatments.
- Determine if CPAP allows for a reduction in normal tissue receiving radiation in chest and abdomen tumors and reduce heart exposure for patients receiving left breast irradiation.
Entry Criteria: This is a proof of concept and feasibility study. We propose to study 10 patients in each group for a total of thirty patients.
Eligibility criteria Group1. Lung tumors and nodules with tumor motion greater than 1 cm on standard imaging (n=10) Group2. Left sided breast tumors with unfavorable anatomy, viz heart abutting chest wall (n=10) Group3. Upper abdominal tumors: Liver and Pancreas with tumor motion greater than 1 cm. (n=10)
Pretreatment evaluations/management for patients meeting eligibility criteria CPAP All patients will be evaluated by a pulmonologist for their respiratory performances including physical examination, oxygen saturation and pulmonary function tests including DLCO that will serve for baseline measures. Then, adjustment session will be performed aiming to get adjusted to a CPAP device till the maximal tolerated pressure is not more than 16 cmH20 (TBD) for 30 minutes.
All patients must be able to tolerate CPAP and comply with daily treatment. 4D CT: CT simulation is the basis of conformal treatment planning [24, 25]. By using a slow acquisition time of 3 minutes the motion effects due to breathing can be captured and a 4D image generated. The tumor position can be imaged throughout the breathing cycle and a Maximum Intensity Projection (MIP) can be constructed and used in treatment planning. If there is no tumor motion the size of the MIP would equal the tumor size. The MIP size will increase with increasing tumor motion. The planning software allows us to calculate the MIP dimensions and volume. In addition total lung volumes and change in diaphragm position can be calculated (Figure 1). Radiation therapy planning parameters and volumetric analysis of tumor and normal tissue motion and position are calculated using available software and transferred to the Eclipse treatment planning system [17].
Treatment Planning:
The Eclipse treatment planning system will be used to generate and compare plans for treatment with and without CPAP.
Details of Intervention
Simulation All treatment planning and CPAP evaluation will be done in the radiation therapy department. Patients will be simulated on the Phillips 4D big bore CT simulator. The 4D scan which is done slowly over several minutes allows us to assess the full range of tumor motion throughout the respiratory cycle. An ITV is calculated which includes the actual tumor size with an expansion to account for the range of motion of the tumor by accounting for tumor location throughout the respiratory cycle (MIP) The MIP is the basis for the ITV and is the structure used for treatment planning. Patients recruited for the study will be re-simulated with the patient in the same position while undergoing CPAP treatment. ITV size and volume will be calculated for the tumor in in both the standard and CPAP studies and used for planning.
RPM: Diaphragm motion and respiratory cycle information will be obtained using the RPM for both the standard and the CPAP simulations. Differences in the respiratory wave cycle will be recorded [17].
The MIP/ITV images will be transferred to the Eclipse treatment planning system and using both the standard breathing and CPAP simulations treatment plans will be generated. Standard radiation plan evaluation parameters will be used and plans compared with respect to tumor coverage and normal tissue and normal tissue in the radiation field.
Radiation Plan:
Identical field arrangements will be generated for CPAP and non CPAP plans. Plans will be evaluated using standard radiation therapy planning parameters including: MIP or ITV, total lung volume, volume of GTV/CTV/PTV/ V20 and MLD.
Pre treatment Compare standard conformal radiation plans using Eclipse treatment planning system for each patient with and without CPAP.
RPM tracings with and without CPAP will be compared for all groups pre- treatment.
- Conditions
- Tumor Motion, "Continuous Positive Airway Pressure", Lung Cancer, Breast Cancer, Abdominal Tumors
- Being tested
- Continuous positive airway pressure (CPAP)
- Medical subject headings
- Lung Neoplasms, Breast Neoplasms, Abdominal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous positive airway pressure (CPAP)Device
CT simulation with and without CPAP
| Study group | Role | What they receive |
|---|---|---|
| Lung tumors | Experimental | Patients with > 1 cm tumor motion simulated using 4DCT with and without CPAP Receives: Device: Continuous positive airway pressure (CPAP) |
| Left sided Breast cancer | Experimental | Patients with heart abutting chest wall will be simulated using 4DCT with and without CPAP Receives: Device: Continuous positive airway pressure (CPAP) |
| Abdominal tumors | Experimental | Patient with liver metastases for SBRT or pancreatic tumors will be simulated using 4DCT with and without CPAP Receives: Device: Continuous positive airway pressure (CPAP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in amplitude of tumor motion
Measurement of the Internal Target Volume in cc
Measured: 2 months
Secondary outcomes (1)
Reduction of radiation dose to critical organs
Mean Lung dose, Mean Heart dose measured in Gy
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2014 (estimated)
- Study startDec 2013
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tumor MotionStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Zvi Symon MD, Sheba Medical Center
- Investigators
- Zvi Symon, MD, Principal investigator, Sheba Medical CenterJeffrey Goldstein, MD, Principal investigator, Sheba Medical CenterYaacov R Lawrence, MD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02324530
- Sponsor's protocol ID
- SMC-13-0637
- Status last verified
- Dec 2014
- First submitted
- 10 Dec 2014
- Last updated
- 24 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of CPAP (Continuous Positive Airway Pressure) in the Planning of Radiation Treatments for Lung, Upper Abdomen and Left Breast Cancers
- ClinicalTrials.gov ID
- NCT02324530
- Acronym / sponsor ID
- SMC-13-0637
- Conditions
- Tumor Motion, "Continuous Positive Airway Pressure", Lung Cancer, Breast Cancer, Abdominal Tumors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Dec 2013
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 24 Dec 2014 (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 is a clinical study on patients to compare the effects of CPAP on lung volume diaphragm motion, heart position and tumor motion compared to free breathing. Only patients with significant tumor motion of greater than 1 cm amplitude or unfavorable chest wall geometry (heart close to chest wall) identified on standard imaging and simulation will be candidates for the study. Patients will be re- simulated and planned for radiation treatments with CPAP. The radiation plans generated with and without CPAP will be compared to evaluate the impact of CPAP on tumor motion and dose delivered to adjacent critical structures such as the heart and lung.
Detailed description
Primary Objectives
- Evaluate effectiveness of CPAP to reproducibly reduce tumor and organ motion during radiation therapy treatments.
- Determine if CPAP allows for a reduction in normal tissue receiving radiation in chest and abdomen tumors and reduce heart exposure for patients receiving left breast irradiation.
Entry Criteria: This is a proof of concept and feasibility study. We propose to study 10 patients in each group for a total of thirty patients.
Eligibility criteria Group1. Lung tumors and nodules with tumor motion greater than 1 cm on standard imaging (n=10) Group2. Left sided breast tumors with unfavorable anatomy, viz heart abutting chest wall (n=10) Group3. Upper abdominal tumors: Liver and Pancreas with tumor motion greater than 1 cm. (n=10)
Pretreatment evaluations/management for patients meeting eligibility criteria CPAP All patients will be evaluated by a pulmonologist for their respiratory performances including physical examination, oxygen saturation and pulmonary function tests including DLCO that will serve for baseline measures. Then, adjustment session will be performed aiming to get adjusted to a CPAP device till the maximal tolerated pressure is not more than 16 cmH20 (TBD) for 30 minutes.
All patients must be able to tolerate CPAP and comply with daily treatment. 4D CT: CT simulation is the basis of conformal treatment planning [24, 25]. By using a slow acquisition time of 3 minutes the motion effects due to breathing can be captured and a 4D image generated. The tumor position can be imaged throughout the breathing cycle and a Maximum Intensity Projection (MIP) can be constructed and used in treatment planning. If there is no tumor motion the size of the MIP would equal the tumor size. The MIP size will increase with increasing tumor motion. The planning software allows us to calculate the MIP dimensions and volume. In addition total lung volumes and change in diaphragm position can be calculated (Figure 1). Radiation therapy planning parameters and volumetric analysis of tumor and normal tissue motion and position are calculated using available software and transferred to the Eclipse treatment planning system [17].
Treatment Planning:
The Eclipse treatment planning system will be used to generate and compare plans for treatment with and without CPAP.
Details of Intervention
Simulation All treatment planning and CPAP evaluation will be done in the radiation therapy department. Patients will be simulated on the Phillips 4D big bore CT simulator. The 4D scan which is done slowly over several minutes allows us to assess the full range of tumor motion throughout the respiratory cycle. An ITV is calculated which includes the actual tumor size with an expansion to account for the range of motion of the tumor by accounting for tumor location throughout the respiratory cycle (MIP) The MIP is the basis for the ITV and is the structure used for treatment planning. Patients recruited for the study will be re-simulated with the patient in the same position while undergoing CPAP treatment. ITV size and volume will be calculated for the tumor in in both the standard and CPAP studies and used for planning.
RPM: Diaphragm motion and respiratory cycle information will be obtained using the RPM for both the standard and the CPAP simulations. Differences in the respiratory wave cycle will be recorded [17].
The MIP/ITV images will be transferred to the Eclipse treatment planning system and using both the standard breathing and CPAP simulations treatment plans will be generated. Standard radiation plan evaluation parameters will be used and plans compared with respect to tumor coverage and normal tissue and normal tissue in the radiation field.
Radiation Plan:
Identical field arrangements will be generated for CPAP and non CPAP plans. Plans will be evaluated using standard radiation therapy planning parameters including: MIP or ITV, total lung volume, volume of GTV/CTV/PTV/ V20 and MLD.
Pre treatment Compare standard conformal radiation plans using Eclipse treatment planning system for each patient with and without CPAP.
RPM tracings with and without CPAP will be compared for all groups pre- treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lung tumors | Experimental | Device: Continuous positive airway pressure (CPAP)Patients with > 1 cm tumor motion simulated using 4DCT with and without CPAP |
| Left sided Breast cancer | Experimental | Device: Continuous positive airway pressure (CPAP)Patients with heart abutting chest wall will be simulated using 4DCT with and without CPAP |
| Abdominal tumors | Experimental | Device: Continuous positive airway pressure (CPAP)Patient with liver metastases for SBRT or pancreatic tumors will be simulated using 4DCT with and without CPAP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Lung tumors and nodules with tumor motion greater than 1 cm on standard imaging
- Left sided breast tumors with unfavorable anatomy, viz heart abutting chest wall
- Upper abdominal tumors: Liver and Pancreas with tumor motion greater than 1 cm. (n=10)
Key exclusion criteria (5 listed)
- Under 18 years old
- Inability to sign informed consent
- Pregnancy,
- Mental Illness,
- Not legally competent
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 |
|---|---|---|
| Continuous positive airway pressure (CPAP)CT simulation with and without CPAP | Device | Abdominal tumors, Left sided Breast cancer, Lung tumors |
Primary outcome
Reduction in amplitude of tumor motion
Time frame: 2 months
Measurement of the Internal Target Volume in cc
1 secondary outcome
Reduction of radiation dose to critical organs
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2014.
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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.
Zvi Symon, MD principal investigator
Sheba Medical Center
Jeffrey Goldstein, MD principal investigator
Sheba Medical Center
Yaacov R Lawrence, MD principal investigator
Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Continuous positive airway pressure (CPAP) in people with Tumor Motion and "Continuous Positive Airway Pressure", run by Sheba Medical Center at 1 site in Israel.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 24 Dec 2014. 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 Israel. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zvi Symon, MD (97235308175, symonz@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in amplitude of tumor motion (time frame: 2 months). 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 24 Dec 2014.