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

• ClinicalTrials.gov Identifier: NCT03669341
• Recruitment Status: Completed
• First Posted: September 13, 2018
• Last Update Posted: June 9, 2021
• Sponsor: Paul Scherrer Institut, Center for Proton Therapy
• Collaborator: Swiss Federal Institute of Technology
• Information provided by (Responsible Party): Paul Scherrer Institut, Center for Proton Therapy

Study Description

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual 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
• Actual Study Start Date: October 10, 2018
• Actual Primary Completion Date: March 11, 2019
• Actual Study Completion Date: August 14, 2019

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Locations

Switzerland

Paul Scherrer Institut, Center for Proton Therapy

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

More Information

Publications:

Emert F, Missimer J, Eichenberger PA, Walser M, Gmür 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.

• Responsible Party: Paul Scherrer Institut, Center for Proton Therapy
• ClinicalTrials.gov Identifier: NCT03669341
• Other Study ID Numbers: APNOPART_2018
• First Posted: September 13, 2018
• Last Update Posted: June 9, 2021
• Last Verified: June 2021

• 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