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OpenTrials
Completed

NCT Number: NCT03669341

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

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.

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Key information

Conditions

Healthy Volunteers

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Paul Scherrer Institut, Center for Proton Therapy

Villigen, Canton of Aargau, 5232, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Difference in breath-hold duration

    Time frame: 3 weeks

    The difference between the DIBH- and HFPV-technique in breath-hold Duration is the secondary outcome measure

Sponsors and collaborators

Lead sponsor

Paul Scherrer Institut, Center for Proton Therapy

Other

Collaborators

  • Swiss Federal Institute of Technology

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 13, 2018
Registry last updated
Jun 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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