Clinical trial NCT03669341: Assessment of 2 Different Techniques for Suppression of Respiratory Motion in Lung Cancer Treatment With Proton Therapy Using Magnetic Resonance Imaging (MRI)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Keywords: breath hold
DIBH
HFPV
MRI
Lead sponsor: Paul Scherrer Institut, Center for Proton Therapy
Sponsor class: OTHER
Collaborators: name: Swiss Federal Institute of Technology
First posted: 2018-09-13
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention 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.
Primary purpose: BASIC_SCIENCE

Brief 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. 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.


Eligibility criteria: 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

Primary outcomes:
measure: Difference in MRI Images
timeFrame: 3 weeks
Secondary outcomes:
measure: Difference in breath-hold duration
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Villigen
country: Switzerland
facility: Paul Scherrer Institut, Center for Proton Therapy
state: Aargau
Study officials:
affiliation: Paul Scherrer Institut, Center for Proton Therapy
name: Frank Emert, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.