Assessment of 2 Different Techniques for Suppression of Respiratory Motion in Lung Cancer Treatment With Proton Therapy Using Magnetic Resonance Imaging (MRI)

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Other: Deep Inspiration Breath Hold (DIBH)
* Other: High Frequency Percussive Ventilation (HFPV)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ability to give informed consent by signature healthy, i.e. normal physical and mental status Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Deep Inspiration Breath Hold (DIBH)<br>DIBH extended by prior hyperventilation while breathing 100% O2 | Other: Deep Inspiration Breath Hold (DIBH)<br>* human-based DIBH method with short-term breath-hold training<br>|
| Active Comparator: High Frequency Percussive Ventilation (HFPV)<br>passive Ventilation by a jet ventilator | Other: High Frequency Percussive Ventilation (HFPV)<br>* device-based HFPV technique<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in breath-hold duration | The difference between the DIBH- and HFPV-technique in breath-hold Duration is the secondary outcome measure | 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breath hold, DIBH, HFPV, MRI