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

NCT03669341 | Completed

• 1 other identifier: APNOPART_2018
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

breath hold; DIBH; HFPV; MRI

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Difference in breath-hold duration

  3 weeks

Study Arms (2)

Deep Inspiration Breath Hold (DIBH)

EXPERIMENTAL

DIBH extended by prior hyperventilation while breathing 100% O2

Other: Deep Inspiration Breath Hold (DIBH)

High Frequency Percussive Ventilation (HFPV)

ACTIVE COMPARATOR

passive Ventilation by a jet ventilator

Other: High Frequency Percussive Ventilation (HFPV)

Interventions

Deep Inspiration Breath Hold (DIBH) OTHER

human-based DIBH method with short-term breath-hold training

Deep Inspiration Breath Hold (DIBH)

High Frequency Percussive Ventilation (HFPV) OTHER

device-based HFPV technique

High Frequency Percussive Ventilation (HFPV)

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ability to give informed consent by signature
• healthy, i.e. normal physical and mental status

You may not qualify if:

• 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

Sponsors & Collaborators

• Paul Scherrer Institut, Center for Proton Therapy: lead
• Swiss Federal Institute of Technology: collaborator

Study Sites (1)

Paul Scherrer Institut, Center for Proton Therapy

Villigen, Canton of Aargau, 5232, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 33996545 BACKGROUND

Study Officials

• Frank Emert, PhD

  Paul Scherrer Institut, Center for Proton Therapy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 11, 2018
• First Posted: September 13, 2018
• Study Start: October 10, 2018
• Primary Completion: March 11, 2019
• Study Completion: August 14, 2019
• Last Updated: June 9, 2021

Record last verified: 2021-06

Locations

CH (1)