To assess the impact of using breathing instructions while performing motion-compensated MR imaging of lesions in the thorax or abdomen aimed at radiotherapy treatment planning as compared to motion-compensated scans without instructions and free-…
ID
Source
Brief title
Condition
- Respiratory and mediastinal neoplasms malignant and unspecified
- Respiratory tract neoplasms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome: Scan time or scan completeness.
Secondary outcome
Patient reported experience, Image quality, Delineation consistency, Compliance
to breathing instructions.
Background summary
To increase precision in radiotherapy treatment of moving organs, use of
motion-compensated scans instead of non-compensated scans is crucial. However,
these motion-compensated free-breathing MRI scans currently suffer from long
and unpredictable scan times and/or variable image quality. Causes for this are
irregular breathing patterns and/or the breathing frequency itself. We
anticipate that scan time and scan quality can be improved by actively guiding
patients to breathe in a certain pattern. Furthermore, active breathing
guidance might also have a positive effect on patient experience. Respiratory
instructions (with Breathing Guidance, non-CE software) are supplied to the
participants by the conventional audiovisual system, which is incorporated in
the MRI room.
Study objective
To assess the impact of using breathing instructions while performing
motion-compensated MR imaging of lesions in the thorax or abdomen aimed at
radiotherapy treatment planning as compared to motion-compensated scans without
instructions and free-breathing scans without motion compensation and without
instruction.
Study design
A mono-center cross-over study
Study population:
12 healthy volunteers and 16 patients with a lesion in the thorax or abdomen,
who are referred to the Radiotherapy department for radiotherapy. Patients and
volunteers should be >18 years old and fluent in Dutch. Patients and volunteers
who have contra-indications for MRI scans will be excluded from study
participation.
Intervention
Participants will be asked to follow breathing instructions according to a user
interface concept 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.
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.
• Dutch speaking
• Healthy volunteers, or
• Patients that (will) receive radiotherapy treatment on a lesion in the thorax
or 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:
o Visual impairment of -3 diopter or worse (see IMDD) which cannot be corrected
through use of contact lenses of MR configurable MR Safe prescription glasses.
o Any other reason that restricts viewing of the in-room display by the
participant (e.g. position of the mirror cannot be changed sufficiently to
allow a view on the screen by the volunteer).
• Auditory impairment:
o Participants that cannot sufficiently hear the audio instructions and
questions over the MRI head phones.
• 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 | NL87853.041.24 |