To assess the feasibility of participants positioned in an MRI scanner to regulate their breathing based on biofeedback
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms benign
- Respiratory tract neoplasms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Percentage of time the breathing instructions are followed correctly as
instructed.
Secondary outcome
- Response time to a new instruction on the GUI concept.
- The number of subject who prematurely stop the MRI.
- The duration of the subject-determined breath hold (SDBH)
- System Usability Scale (SUS)
Background summary
Respiratory motion is an important source of targeting uncertainty that affects
abdominal and thoracic external-beam radiotherapy deliveries. Treatment
simulation imaging and treatment deliveries can benefit from active breathing
regulation techniques which ensure that patients are irradiated in a favourable
anatomy.
Biofeedback systems are needed to ensure optimal compliance with breathing
instructions.
Before clinical implementation in radiotherapy workflows, the technical
feasibility of different biofeedback system prototypes needs to be established.
Study objective
To assess the feasibility of participants positioned in an MRI scanner to
regulate their breathing based on biofeedback
Study design
A mono-center feasibility study at the UMCU with a cross-sectional design
Intervention
Participants will be asked to follow breathing instructions according to user
interface concepts explored during research-only MR imaging sessions
Study burden and risks
No risk or treatment-related benefit is expected. Participants are asked to
participate in a single MR imaging session and fill out questionnaires.
Imposed breathing instructions, in addition to a small risk of
hyperventilating, have a real risk of triggering mild anxiety.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL82354.041.23 |