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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)

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ClinicalTrials.gov Identifier: NCT03669341
Recruitment Status : Recruiting
First Posted : September 13, 2018
Last Update Posted : October 5, 2018
Sponsor:
Collaborator:
Swiss Federal Institute of Technology
Information provided by (Responsible Party):
Paul Scherrer Institut, Center for Proton Therapy

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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Other: Deep Inspiration Breath Hold (DIBH) Other: High Frequency Percussive Ventilation (HFPV) Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
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.
Masking: None (Open Label)
Primary Purpose: Basic Science
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
Estimated Study Start Date : October 2018
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: MRI Scans

Arm Intervention/treatment
Experimental: Deep Inspiration Breath Hold (DIBH)
DIBH extended by prior hyperventilation while breathing 100% O2
Other: Deep Inspiration Breath Hold (DIBH)
human-based DIBH method with short-term breath-hold training

Active Comparator: High Frequency Percussive Ventilation (HFPV)
passive Ventilation by a jet ventilator
Other: High Frequency Percussive Ventilation (HFPV)
device-based HFPV technique




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03669341


Contacts
Contact: Frank Emert, PhD +41 56 310 ext 4269 frank.emert@psi.ch

Locations
Switzerland
Paul Scherrer Institut, Center for Proton Therapy Recruiting
Villigen, Aargau, Switzerland, 5232
Sponsors and Collaborators
Paul Scherrer Institut, Center for Proton Therapy
Swiss Federal Institute of Technology
Investigators
Principal Investigator: Frank Emert, PhD Paul Scherrer Institut, Center for Proton Therapy

Responsible Party: Paul Scherrer Institut, Center for Proton Therapy
ClinicalTrials.gov Identifier: NCT03669341     History of Changes
Other Study ID Numbers: APNOPART_2018
First Posted: September 13, 2018    Key Record Dates
Last Update Posted: October 5, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Paul Scherrer Institut, Center for Proton Therapy:
breath hold
DIBH
HFPV
MRI