Healthy VolunteersNCT03669341
Assessment of 2 Different Techniques for Suppression of Respiratory Motion in Lung Cancer Treatment With Proton Therapy Using Magnetic Resonance Imaging (MRI)
A study testing Deep Inspiration Breath Hold (DIBH) and High Frequency Percussive Ventilation (HFPV) in people with Healthy Volunteers, run by Paul Scherrer Institut, Center for Proton Therapy at 1 site in Switzerland.
Trial summary
Since 1996 proton therapy has been applied very successfully at the Paul Scherrer Institute in Switzerland to irradiate deep-seated, stationary tumors. In order to treat tumors within an organ which moves due to breathing (e.g. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Deep Inspiration Breath Hold (DIBH) and High Frequency Percussive Ventilation (HFPV)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- 10 Oct 2018to 14 Aug 2019
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ability to give informed consent by signature
- healthy, i.e. normal physical and mental status
Who cannot join
- contraindications to MRI (non-MRI-suitable electronical \& metal implants, claustrophobia)
- women who are pregnant or are breast feeding
- acute or chronic illness
- 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
- presence of any psychological or sociological condition potentially hampering compliance with the study protocol
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Paul Scherrer Institut, Center for Proton Therapy
Villigen, Canton of Aargau, 5232
About this study
Official title: Short-term Apnoea Training With Deep Inspiration Breath Hold vs High Frequency Percussive Ventilation for Apnoea-like Suppression of Respiratory Motion: a Pilot Study Using Magnetic Resonance Imaging at 1.5T Assessing Their Application for Proton Therapy Treatment of Lung Tumors
Since 1996 proton therapy has been applied very successfully at the Paul Scherrer Institute in Switzerland to irradiate deep-seated, stationary tumors. In order to treat tumors within an organ which moves due to breathing (e.g. lung) motion mitigation strategies need to be implemented to ensure the precise irradiation of the moving target. The aim of this study is to assess the feasibility and compare (via MRI imaging) 2 techniques which "freeze" the movement of the lung by breath hold. One method is suppression of respiratory movement via high-frequency, mechanical ventilation by means of a Jet Ventilator (HFPV). The other technique is deep Inspiration breath-hold (DIBH) with Hyperventilation and simultaneous Inspiration of 100% O2 including daily breath-hold exercise.
- Conditions
- Healthy Volunteers
- Being tested
- Deep Inspiration Breath Hold (DIBH), High Frequency Percussive Ventilation (HFPV)
- Keywords
- breath hold, DIBH, HFPV, MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep Inspiration Breath Hold (DIBH)Other
human-based DIBH method with short-term breath-hold training
High Frequency Percussive Ventilation (HFPV)Other
device-based HFPV technique
| Study group | Role | What they receive |
|---|---|---|
| Deep Inspiration Breath Hold (DIBH) | Experimental | DIBH extended by prior hyperventilation while breathing 100% O2 Receives: Other: Deep Inspiration Breath Hold (DIBH) |
| High Frequency Percussive Ventilation (HFPV) | Active comparator | passive Ventilation by a jet ventilator Receives: Other: High Frequency Percussive Ventilation (HFPV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in MRI Images
pulmonary anatomical structure points are evaluated by means of MRI scans. The difference of these MRI evaluations between the DIBH- and HFPV-technique is the primary outcome measure.
Measured: 3 weeks
Secondary outcomes (1)
Difference in breath-hold duration
The difference between the DIBH- and HFPV-technique in breath-hold Duration is the secondary outcome measure
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2018
- Study start10 Oct 2018
- Primary completion11 Mar 2019
- Study completion14 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Sequential
- Model description
- All study participants will perform both techniques of suppression of respiratory motion at 4 weekly visits. They always start with the deep-inspiration-breath- hold (DIBH) technique, extended by prior hyperventilation while breathing 100% O2, followed by the high-frequency-percussive-ventilation (HFPV) technique. Inbetween the weekly visits, participants are requested to perform a daily, short breath-hold training at home.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Paul Scherrer Institut, Center for Proton Therapy
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss Federal Institute of Technology
- Responsible party
- Sponsor
- Investigators
- Frank Emert, PhD, Principal investigator, Paul Scherrer Institut, Center for Proton Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03669341
- Sponsor's protocol ID
- APNOPART_2018
- Status last verified
- Jun 2021
- First submitted
- 11 Sep 2018
- Last updated
- 9 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Emert F, Missimer J, Eichenberger PA, Walser M, Gmur C, Lomax AJ, Weber DC, Spengler CM. Enhanced Deep-Inspiration Breath Hold Superior to High-Frequency Percussive Ventilation for Respiratory Motion Mitigation: A Physiology-Driven, MRI-Guided Assessment Toward Optimized Lung Cancer Treatment With Proton Therapy. Front Oncol. 2021 Apr 29;11:621350. doi: 10.3389/fonc.2021.621350. eCollection 2021.
PubMed 33996545
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Apnoea Training With Deep Inspiration Breath Hold vs High Frequency Percussive Ventilation for Apnoea-like Suppression of Respiratory Motion: a Pilot Study Using Magnetic Resonance Imaging at 1.5T Assessing Their Application for Proton Therapy Treatment of Lung Tumors
- ClinicalTrials.gov ID
- NCT03669341
- Acronym / sponsor ID
- APNOPART_2018
- Conditions
- Healthy Volunteers
- Keywords
- breath hold, DIBH, HFPV, MRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Paul Scherrer Institut, Center for Proton TherapyUniversity, hospital or other
- Collaborators
- Swiss Federal Institute of Technology
- Study start
- 10 Oct 2018 (actual)
- Primary completion
- 11 Mar 2019 (actual)
- Study completion
- 14 Aug 2019 (actual)
- First posted
- 13 Sep 2018 (actual)
- 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.
Since 1996 proton therapy has been applied very successfully at the Paul Scherrer Institute in Switzerland to irradiate deep-seated, stationary tumors. In order to treat tumors within an organ which moves due to breathing (e.g. lung) motion mitigation strategies need to be implemented to ensure the precise irradiation of the moving target. The aim of this study is to assess the feasibility and compare (via MRI imaging) 2 techniques which "freeze" the movement of the lung by breath hold. One method is suppression of respiratory movement via high-frequency, mechanical ventilation by means of a Jet Ventilator (HFPV). The other technique is deep Inspiration breath-hold (DIBH) with Hyperventilation and simultaneous Inspiration of 100% O2 including daily breath-hold exercise.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All study participants will perform both techniques of suppression of respiratory motion at 4 weekly visits. They always start with the deep-inspiration-breath- hold (DIBH) technique, extended by prior hyperventilation while breathing 100% O2, followed by the high-frequency-percussive-ventilation (HFPV) technique. Inbetween the weekly visits, participants are requested to perform a daily, short breath-hold training at home.
| Arm | Type | Receives |
|---|---|---|
| Deep Inspiration Breath Hold (DIBH) | Experimental | Other: Deep Inspiration Breath Hold (DIBH)DIBH extended by prior hyperventilation while breathing 100% O2 |
| High Frequency Percussive Ventilation (HFPV) | Active comparator | Other: High Frequency Percussive Ventilation (HFPV)passive Ventilation by a jet ventilator |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ability to give informed consent by signature
- healthy, i.e. normal physical and mental status
Key exclusion criteria (6 listed)
- contraindications to MRI (non-MRI-suitable electronical \& metal implants, claustrophobia)
- women who are pregnant or are breast feeding
- acute or chronic illness
- 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
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 |
|---|---|---|
| Deep Inspiration Breath Hold (DIBH)human-based DIBH method with short-term breath-hold training | Other | Deep Inspiration Breath Hold (DIBH) |
| High Frequency Percussive Ventilation (HFPV)device-based HFPV technique | Other | High Frequency Percussive Ventilation (HFPV) |
Primary outcome
Difference in MRI Images
Time frame: 3 weeks
pulmonary anatomical structure points are evaluated by means of MRI scans. The difference of these MRI evaluations between the DIBH- and HFPV-technique is the primary outcome measure.
1 secondary outcome
Difference in breath-hold duration
Time frame: 3 weeks
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 9 Jun 2021.
- Background: PubMed 33996545Emert F, Missimer J, Eichenberger PA, Walser M, Gmur C, Lomax AJ, Weber DC, Spengler CM. Enhanced Deep-Inspiration Breath Hold Superior to High-Frequency Percussive Ventilation for Respiratory Motion Mitigation: A Physiology-Driven, MRI-Guided Assessment Toward Optimized Lung Cancer Treatment With Proton Therapy. Front Oncol. 2021 Apr 29;11:621350. doi: 10.3389/fonc.2021.621350. eCollection 2021.
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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.
Frank Emert, PhD principal investigator
Paul Scherrer Institut, Center for Proton Therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep Inspiration Breath Hold (DIBH) and High Frequency Percussive Ventilation (HFPV) in people with Healthy Volunteers, run by Paul Scherrer Institut, Center for Proton Therapy 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 2 inclusion and 6 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 9 Jun 2021. 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?
Difference in MRI Images (time frame: 3 weeks). 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 NCT03669341, which also lists 1 linked publication.
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 9 Jun 2021.