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

P

Paul Scherrer Institut, Center for Proton Therapy

Status

Completed

Conditions

Healthy Volunteers

Treatments

Other: High Frequency Percussive Ventilation (HFPV)
Other: Deep Inspiration Breath Hold (DIBH)

Study type

Interventional

Funder types

Other

Identifiers

NCT03669341
APNOPART_2018

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

All

Ages

40+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

20 participants in 2 patient groups

Deep Inspiration Breath Hold (DIBH)
Experimental group
Description:
DIBH extended by prior hyperventilation while breathing 100% O2
Treatment:
Other: Deep Inspiration Breath Hold (DIBH)
High Frequency Percussive Ventilation (HFPV)
Active Comparator group
Description:
passive Ventilation by a jet ventilator
Treatment:
Other: High Frequency Percussive Ventilation (HFPV)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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