The aim of the study is to improve the positioning of patients who are irradiated on the breast. Optical surface scanning will be used and the precision, patient friendliness, and process optimization are studied.
ID
Source
Brief title
Condition
- Breast neoplasms malignant and unspecified (incl nipple)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Rate of success of the set-up.
Secondary outcome
Number of images and displacement of the couch are secondary study parameters.
Background summary
A radiation therapy treatment requires a precise and reproducible position and
posture of the patient on the treatment couch. It is important that motion of
the patient is avoided during the treatment. The current method consists of
tattoos on the skin of the patient, which are used to set-up the patient. In
this study optical surface scanning is used to position the patient. An optical
surface scanner creates a 3D image of the patient and can be used to improve
the positioning of patients and to perform intra-fractional motion management.
During irradiation of the breast, patients hold their breath, hence the
distance from the heart to the thorax wall is maximized and the heart will
receive less radiation. Optical surface scanning is also use to monitor this
breath-hold.
Study objective
The aim of the study is to improve the positioning of patients who are
irradiated on the breast. Optical surface scanning will be used and the
precision, patient friendliness, and process optimization are studied.
Study design
This study is a clinical feasibility study. Clinical feasibility in this study
is defined when more than 80% of the patients are positioned successfully by
using optical surface scanning. A successful set-up is determined by measuring
the angle of the clavicle on the online made image. All subjects participating
in the study receive local or locoregional breast irradiation and optical
surface scanning is used for set-up and breath-hold monitoring.
Intervention
The intervention in this study concerns the treatment method of local or
locoregional breast irradiation; the treatment itself is the same whether
patients participate in the study or not. Patient set-up is performed using
optical surface scanning and the tattoo points are not required any more. As is
common with radiotherapy of the breast, online imaging is used for a
reproducible inter-fractional position of the patient. For intra-fractional
breath-hold monitoring an optical surface scanner is used. The therapists can
see the depth of the breath hold on a screen. Patients are instructed to repeat
the breath-hold procedure, if necessary. The surface scanner used for this
study is IDENTIFY (HumediQ/Varian), which constructs a 3D-reconstruction of a
subject. The actual position of the patient is compared to a daily made
reference image and the deviation is presented on a screen.
Study burden and risks
Participation in the study means subjects are positioned using a new method,
consisting of optical surface scanning. The advantage for patients is that
tattoo points on the skin are not needed. Another advantage can be that the
positioning will be faster and more precise. Side effects of the radiation
treatment can occur. These effects do not differ whether a patient participates
in the study or not.
Brugstraat 10
Tilburg 5042SB
NL
Brugstraat 10
Tilburg 5042SB
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
* The therapy consists of local or locoregional breast irradiation with
voluntary moderate deep inspiration breath-hold.
* The patient is willing to travel to Tilburg for the treatment.
* The patient is motivated and willing to be involved in radiation therapy
using surface scanning for positioning and motion monitoring.
* The patient is competent enough to understand the Dutch language to follow up
instructions of the radiation technologist.
Exclusion criteria
Males are excluded from participation in the study. Patients where bolus
material is necessary to achieve sufficient skin dose are excluded as well.
Patients who are irradiated at more than one treatment site are also excluded
and patients who are treated with the FAST(-Forward) schedule are excluded.
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 | NL69214.028.19 |