Surface Monitoring Technology to Remove The Mask - Stage 1
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Sydney
About this trial
A pilot-stage device feasibility study investigating a mask-free motion-monitoring patient immobilisation system for use during radiation therapy treatment of head and neck cancer (HNC). This mask-free system combines the standard radiation therapy (RT) head rest to help the patient remain still with a surface guidance detection system that uses sensors to detect and track patient movement.
Patients who will have RT treatment for head and neck cancer involving an immobilisation mask will be asked to lie on the treatment couch for the normal treatment fraction time while the surface monitoring system is activated. We will then assess:
i) The level of acceptance of the system by HNC patients currently being treated with RT using an immobilisation mask, and ii) The ability of the surface guidance system to monitor movement of the patients
Eligibility criteria
Qualifiers
A diagnosis of head and neck cancer, any stage
≥ 18 years of age
ECOG performance status 0-2
Receiving radiation therapy for HNC with a thermoplastic immobilisation mask
Disqualifiers
People with cognitive impairment which would preclude them from providing informed consent
People who are unable to speak and read English and for whom obtaining consent would be difficult.
Participants may withdraw from the study at any time before, during or after participation, and do not have to provide a reason. They may do so by advising any member of the study team, research office or their treating team, by completing the withdrawal of consent form, verbally or in writing.
Participants may be withdrawn from the study by the principal investigator, treating physician or attending clinician if they perceive the participant is experiencing or will likely experience physical or mental harm
Trial design
Treatments tested in this trial
- Mask-free surface monitoring
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
University of Sydney
Lead sponsor
Western Sydney Local Health District
Collaborator
Source ClinicalTrials.gov