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New treatment option for Head and Neck Cancer
Official title Surface Monitoring Technology to Remove The Mask - Stage 1
ClinicalTrials.gov ID: NCT04266223
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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...
- Participants may be withdrawn from the study by the principal investigator, treating physician or attending clinician if they perceive the...
- 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...
See the full eligibility 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
- 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...
- 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...
- 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...
- Reasons for withdrawal will be reported in any outcome publications.
The study team makes the final eligibility decision.
Where it's taking place
- Blacktown, New South Wales, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Blacktown, New South Wales, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.