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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Other: Deep Inspiration Breath Hold (DIBH); Other: High Frequency Percussive Ventilation (HFPV)

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Aargau
    • Villigen, Aargau, Switzerland, 5232
      • Paul Scherrer Institut, Center for Proton Therapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in MRI Images	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.	3 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Paul Scherrer Institut, Center for Proton Therapy
• Collaborators: Swiss Federal Institute of Technology
• Investigators: Principal Investigator: Frank Emert, PhD, Paul Scherrer Institut, Center for Proton Therapy

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2018
• Primary Completion (Actual): March 11, 2019
• Study Completion (Actual): August 14, 2019

Study Registration Dates

• First Submitted: September 11, 2018
• First Submitted That Met QC Criteria: September 12, 2018
• First Posted (Actual): September 13, 2018

Study Record Updates

• Last Update Posted (Actual): June 9, 2021
• Last Update Submitted That Met QC Criteria: June 4, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: MRI; DIBH; breath hold; HFPV
• Other Study ID Numbers: APNOPART_2018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No