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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03669341
• Other study ID #: APNOPART_2018
• Status: Completed
• Phase: N/A
• Start date: October 10, 2018
• Est. completion date: August 14, 2019

Study information

• Verified date: June 2021
• Source: Paul Scherrer Institut, Center for Proton Therapy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 14, 2019
• Est. primary completion date: March 11, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Other:
• Deep Inspiration Breath Hold (DIBH)
human-based DIBH method with short-term breath-hold training
• High Frequency Percussive Ventilation (HFPV)
device-based HFPV technique

Locations

Country	Name	City	State
Switzerland	Paul Scherrer Institut, Center for Proton Therapy	Villigen	Aargau

Sponsors (2)

Lead Sponsor	Collaborator
Paul Scherrer Institut, Center for Proton Therapy	Swiss Federal Institute of Technology

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Difference in breath-hold duration	The difference between the DIBH- and HFPV-technique in breath-hold Duration is the secondary outcome measure	3 weeks