NCT04266223 Surface Monitoring Technology to Remove The Mask - Stage 1
| NCT ID | NCT04266223 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Sydney |
| Condition | Head and Neck Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2023-03-28 |
| Primary Completion | 2024-11-30 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2023-03-28 with a primary completion date of 2024-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria * 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 * Any other prior therapy allowed * Willing and able to comply with all study requirements * Must be able to read and complete questionnaires in English Exclusion Criteria * 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. Withdrawal Criteria * 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 * No additional study data will be collected for a participant after they withdraw from the study * Withdrawing participants' data will be used unless the participant specifies they no longer give permission for the data to be stored or used, however, their data will not be removed from any analysis or publication that has already occurred, or from study databases once it has been de-identified * Participant will be replaced if they withdraw or are withdrawn from the study prior to starting the second couch session. This will be done by recruitment of an additional participant. * If a couch session is ended by the researcher or participant for reasons unrelated to the study (e.g. not related to equipment failure or participant non-acceptance), the session may be rescheduled, or participant replaced. * Reasons for withdrawal will be reported in any outcome publications.
Contact & Investigator
Purmina Sundaresan, Dr
PRINCIPAL INVESTIGATOR
Western Sydney Local Health District
Frequently Asked Questions
Who can join the NCT04266223 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Head and Neck Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04266223 currently recruiting?
Yes, NCT04266223 is actively recruiting participants. Contact the research team at paul.keall@sydney.edu.au for enrollment information.
Where is the NCT04266223 trial being conducted?
This trial is being conducted at Blacktown, Australia.
Who is sponsoring the NCT04266223 clinical trial?
NCT04266223 is sponsored by University of Sydney. The principal investigator is Purmina Sundaresan, Dr at Western Sydney Local Health District. The trial plans to enroll 20 participants.
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