Respiratory AmplitudeNCT02820532
Influence of Couch Tracking Motion
A study testing Protura Treatment table in people with Respiratory Amplitude, run by University of Zurich at 1 site in Switzerland.
Trial summary
Tumor motion increases the uncertainty in Radiation Oncology. Couch tracking can compensate for this uncertainty. However it is not known if the couch motion influences the respiratory pattern of the patients. This will be evaluated in this study on healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Amplitude
- What is being tested?
- Protura Treatment table
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jul 2016to Apr 2018
- Phase
- Interventional
- 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 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers
- Male and Female subjects
- ≥18 and ≤100 years
- Written informed consent by the participant after information about the project
- German speaking
Who cannot join
- Known or suspected non-compliance, drug or alcohol abuse,
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
- Body weight exceeding 200kg
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Couch Tracking Motion on Physiological Parameters
Tumor motion increases the uncertainty in Radiation Oncology. Couch tracking can compensate for this uncertainty. However it is not known if the couch motion influences the respiratory pattern of the patients. This will be evaluated in this study on healthy volunteers.
Read the detailed description
Radiation therapy is one of the main options in cancer treatments, alongside surgery and chemotherapy. Its efficacy largely depends on the absorbed radiation dose of the tumor cells. However, the irradiation of healthy cells results in negative side effects for the patient. Therefore, a big challenge in radiation therapy is to irradiate the tumor with sufficient dose, while keeping the irradiation of the healthy tissue reasonably low. Currently, the radiation treatment is planned by defining a volume enclosing the tumor, but with added margins to account for any uncertainties. These margins ensure that the tumor receives the prescribed dose.
Tumor motion contributes to the uncertainties. The tumor motions of tumors in different sites have different causes, but for this project the focus is on thoracic, liver, and adrenal gland tumors. The motion of these tumor types is mainly caused by the patient's respiration. So, the tumor motion pattern depends on the respiration pattern of the patient. The motion of lung tumors has been reported to have a peak-to-peak amplitude of up to 24 mm. Currently, the tumor motion is handled by enlarging the margins, such that the tumor is always inside the defined volume. But enlarging the margins also results in an increase of irradiated volume consisting of healthy tissue.
Tumor motion mitigation is concerned with reducing the margin increase caused by the motion of the tumor. There are several approaches to tumor motion mitigation and the one under consideration in this project is the tumor tracking approach, the technically most difficult approach. In tumor tracking the tumor motion is continuously compensated by moving the radiation source modifying the radiation beam, or moving the patient, which is denoted as couch tracking.
In couch tracking, the patient is moved by the robotic treatment couch. Such robotic treatment couches are in use with conventional, widely available C-arm linear accelerators, and, therefore, are readily available for implementing couch tracking. The patient is placed on a couch which moves in the opposite direction of the tumor motion. The goal is to minimize the patient's tumor motion relative to the radiation, which in turn allows the margins to be decreased. The margin decrease might ultimately lead to a reduction of side effects, e.g. pneumonitis.
The motion of the couch depends on the motion of the tumor, which in turn depends on the respiration of the patient. However, the couch motion may influence the patient's well being or the patient's respiration. So the question arises: Does the motion of the couch have an influence on the respiration behavior? And also: Does the motion of the couch have an influence on the well being (motion sickness)? And are the well-being and the respiration behavior connected? If the respiration behavior does depend on the couch motion, it may be necessary to control the respiration behavior. Additionally, in the study, the investigators will check an assumption in couch tracking, namely that the patient's body is rigidly fixed to the couch. If this assumption does not hold, the motion of the patient's body relative to the couch will have to be taken into account in couch tracking.
- Conditions
- Respiratory Amplitude
- Being tested
- Protura Treatment table
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protura Treatment tableDevice
The treatment couch will be moved according to the respiratory motion of the patient. As a reference first the respiration will be measured without couch motion, than the couch will be switched on and we will evaluate if the respiration changes due to the motion of the couch. This procedure will be repeated once.
| Study group | Role | What they receive |
|---|---|---|
| Tracking | Other | The volunteers will be placed on the treatment couch. Their respiratory motion will be measured and the treatment couch will be moved accordingly. During the couch motion experiment the heartbeat, the skin humidity, the respiratory characteristics and the pupil motion will be additionally measured. Receives: Device: Protura Treatment table |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory amplitude
Change of respiratory motion due to couch motion. Respiration will be measured on the chest wall using a contact-free measurement.
Measured: baseline and 20 min
Secondary outcomes (5)
Heart beat
The heart beat will be measured on the palm of the hand during the static and the couch motion phase.
Measured: baseline and 20 min
Skin humidity
The skin humidity will be measured on the hand palm during the static and the phase in motion.
Measured: baseline and 20 min
Pupil motion
The change in pupil motion during tracking compared to static condition will be assessed using eye tracking glasses.
Measured: baseline and 20 min
Body motion
The influence of the couch motion on the body motion will be assessed using a surface detection system.
Measured: baseline and 20 min
Motion sickness
With a questionaire the motion sickness is assessed, which the participants might experience during couch motion
Measured: baseline and 20 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionApr 2018
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Respiratory AmplitudeStudies of the same condition, open and under way.
- More trials run by University of ZurichThe 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 N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Technical University Zurich
- Responsible party
- Sponsor
- Investigators
- Matthias Guckenberger, MD, Principal investigator, University Hospital Zurich, Department of Radiation Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02820532
- Sponsor's protocol ID
- 2016-00163
- Other IDs
- 2016
- Status last verified
- May 2018
- First submitted
- 20 Jun 2016
- Last updated
- 8 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Johl A, Bogowicz M, Ehrbar S, Guckenberger M, Klock S, Meboldt M, Riesterer O, Zeilinger M, Schmid Daners M, Tanadini-Lang S. Body motion during dynamic couch tracking with healthy volunteers. Phys Med Biol. 2018 Dec 19;64(1):015001. doi: 10.1088/1361-6560/aaf361.
PubMed 30523943Johl A, Bogowicz M, Ehrbar S, Guckenberger M, Klock S, Meboldt M, Riesterer O, Zeilinger M, Schmid Daners M, Tanadini-Lang S. Unconscious physiological response of healthy volunteers to dynamic respiration-synchronized couch motion. Radiat Oncol. 2017 Nov 28;12(1):189. doi: 10.1186/s13014-017-0925-6.
PubMed 29183337
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Couch Tracking Motion on Physiological Parameters
- ClinicalTrials.gov ID
- NCT02820532
- Acronym / sponsor ID
- 2016-00163
- Conditions
- Respiratory Amplitude
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Technical University Zurich
- Study start
- Jul 2016
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 1 Jul 2016 (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.
Tumor motion increases the uncertainty in Radiation Oncology. Couch tracking can compensate for this uncertainty. However it is not known if the couch motion influences the respiratory pattern of the patients. This will be evaluated in this study on healthy volunteers.
Detailed description
Radiation therapy is one of the main options in cancer treatments, alongside surgery and chemotherapy. Its efficacy largely depends on the absorbed radiation dose of the tumor cells. However, the irradiation of healthy cells results in negative side effects for the patient. Therefore, a big challenge in radiation therapy is to irradiate the tumor with sufficient dose, while keeping the irradiation of the healthy tissue reasonably low. Currently, the radiation treatment is planned by defining a volume enclosing the tumor, but with added margins to account for any uncertainties. These margins ensure that the tumor receives the prescribed dose.
Tumor motion contributes to the uncertainties. The tumor motions of tumors in different sites have different causes, but for this project the focus is on thoracic, liver, and adrenal gland tumors. The motion of these tumor types is mainly caused by the patient's respiration. So, the tumor motion pattern depends on the respiration pattern of the patient. The motion of lung tumors has been reported to have a peak-to-peak amplitude of up to 24 mm. Currently, the tumor motion is handled by enlarging the margins, such that the tumor is always inside the defined volume. But enlarging the margins also results in an increase of irradiated volume consisting of healthy tissue.
Tumor motion mitigation is concerned with reducing the margin increase caused by the motion of the tumor. There are several approaches to tumor motion mitigation and the one under consideration in this project is the tumor tracking approach, the technically most difficult approach. In tumor tracking the tumor motion is continuously compensated by moving the radiation source modifying the radiation beam, or moving the patient, which is denoted as couch tracking.
In couch tracking, the patient is moved by the robotic treatment couch. Such robotic treatment couches are in use with conventional, widely available C-arm linear accelerators, and, therefore, are readily available for implementing couch tracking. The patient is placed on a couch which moves in the opposite direction of the tumor motion. The goal is to minimize the patient's tumor motion relative to the radiation, which in turn allows the margins to be decreased. The margin decrease might ultimately lead to a reduction of side effects, e.g. pneumonitis.
The motion of the couch depends on the motion of the tumor, which in turn depends on the respiration of the patient. However, the couch motion may influence the patient's well being or the patient's respiration. So the question arises: Does the motion of the couch have an influence on the respiration behavior? And also: Does the motion of the couch have an influence on the well being (motion sickness)? And are the well-being and the respiration behavior connected? If the respiration behavior does depend on the couch motion, it may be necessary to control the respiration behavior. Additionally, in the study, the investigators will check an assumption in couch tracking, namely that the patient's body is rigidly fixed to the couch. If this assumption does not hold, the motion of the patient's body relative to the couch will have to be taken into account in couch tracking.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tracking | Other | Device: Protura Treatment tableThe volunteers will be placed on the treatment couch. Their respiratory motion will be measured and the treatment couch will be moved accordingly. During the couch motion experiment the heartbeat, the skin humidity, the respiratory characteristics and the pupil motion will be additionally measured. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy volunteers
- Male and Female subjects
- ≥18 and ≤100 years
- Written informed consent by the participant after information about the project
- German speaking
Key exclusion criteria (3 listed)
- Known or suspected non-compliance, drug or alcohol abuse,
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
- Body weight exceeding 200kg
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 |
|---|---|---|
| Protura Treatment tableThe treatment couch will be moved according to the respiratory motion of the patient. As a reference first the respiration will be measured without couch motion, than the couch will be switched on and we will evaluate if the respiration changes due to the motion of the couch. This procedure will be repeated once. | Device | Tracking |
Primary outcome
Respiratory amplitude
Time frame: baseline and 20 min
Change of respiratory motion due to couch motion. Respiration will be measured on the chest wall using a contact-free measurement.
5 secondary outcomes
Heart beat
Time frame: baseline and 20 min
Skin humidity
Time frame: baseline and 20 min
Pupil motion
Time frame: baseline and 20 min
Body motion
Time frame: baseline and 20 min
Motion sickness
Time frame: baseline and 20 min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2018.
- Derived from this study: PubMed 30523943Johl A, Bogowicz M, Ehrbar S, Guckenberger M, Klock S, Meboldt M, Riesterer O, Zeilinger M, Schmid Daners M, Tanadini-Lang S. Body motion during dynamic couch tracking with healthy volunteers. Phys Med Biol. 2018 Dec 19;64(1):015001. doi: 10.1088/1361-6560/aaf361.
- Derived from this study: PubMed 29183337Johl A, Bogowicz M, Ehrbar S, Guckenberger M, Klock S, Meboldt M, Riesterer O, Zeilinger M, Schmid Daners M, Tanadini-Lang S. Unconscious physiological response of healthy volunteers to dynamic respiration-synchronized couch motion. Radiat Oncol. 2017 Nov 28;12(1):189. doi: 10.1186/s13014-017-0925-6.
- Individual participant dataSharing planned: Undecided
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RecruitingObservational study
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Obstructive Sleep Apnea (OSA), CPAP
RecruitingObservational study
Respiratory Support and Brain Health in Preterm Infants
Sleep, Cerebral Oxygenation
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.
Matthias Guckenberger, MD principal investigator
University Hospital Zurich, Department of Radiation Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protura Treatment table in people with Respiratory Amplitude, run by University of Zurich at 1 site in Switzerland.
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 5 inclusion and 3 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: finished, as of the sponsor's last update on 8 May 2018. 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 Switzerland. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Respiratory amplitude (time frame: baseline and 20 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02820532, which also lists 2 linked publications.
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 8 May 2018.