trecht Breathing Regulation Effectiveness for Abdominal and THoracic External-beam Radiotherapy (U-BREATHER)

Completed

• Conditions: breathing regulation; radiotherapy; 10027656; 10029107

• Registration Number: NL-OMON53578
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 24

Inclusion Criteria

- >= 18 years.
- Capable to provide informed consent.
- Healthy volunteers
or
- Patients that receive treatment on a tumor-lesion in the thorax or
upper abdomen.

Exclusion Criteria

- Contraindication for MRI scanning as listed in screening form.
- Refusal of subjects to be informed of chance findings possibly relevant to
their health
- In case study participation would interfere with regular treatment.
- Visual impairment in treatment position including:
o Visual impairment that cannot be corrected through use of MR
Safe contact lenses of
MR configurable MR Safe prescription glasses.
o Visual impairment due to treatment position or treatment
position devices
- Severe obstructive or restrictive lung disease: If a participant suffers from
severe obstructive or
restrictive lung disease, or unaware of the severity, a pulmonary
specialist will be consulted to
determine whether participation is safe.
- Pregnancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Percentage of time the breathing instructions are followed correctly as<br /><br>instructed.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Response time to a new instruction on the GUI concept.<br /><br>- The number of subject who prematurely stop the MRI.<br /><br>- The duration of the subject-determined breath hold (SDBH)<br /><br>- System Usability Scale (SUS)</p><br>