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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03669341

Enrollment

Registered

2018-09-13

Start date

2018-10-10

Completion date

2019-08-14

Last updated

2021-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Keywords

breath hold, DIBH, HFPV, MRI

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.

Interventions

OTHERDeep Inspiration Breath Hold (DIBH)

human-based DIBH method with short-term breath-hold training

OTHERHigh Frequency Percussive Ventilation (HFPV)

device-based HFPV technique

Study design

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

BASIC_SCIENCE

Masking

NONE

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.

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Difference in MRI Images	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.

Secondary

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

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026