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Trial registered on ANZCTR
Registration number
ACTRN12621001505897
Ethics application status
Approved
Date submitted
31/08/2021
Date registered
4/11/2021
Date last updated
23/06/2024
Date data sharing statement initially provided
4/11/2021
Type of registration
Prospectively registered
Titles & IDs
Public title
Breathing Motion Assessment on the Varian Halcyon Treatment Machine for Patients Receiving Radiation Therapy
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Scientific title
Breathing Motion Assessment on the Varian Halcyon Treatment Machine for Patients Receiving Radiation Therapy
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Secondary ID [1]
305184
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Nil
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Universal Trial Number (UTN)
U1111-1269-1413
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cancer
323458
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Condition category
Condition code
Cancer
321008
321008
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0
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Any cancer
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
The study is looking at whether the Live View System (LVS) camera on the end of the Varian Halcyon treatment couch can be used for breath hold gating in comparison to the wall mounted real time position management (RPM) system that is currently being used. One treatment for each patient will be observed using both both the LVS system and the RPM system.
The LVS and RPM system both monitor the motion of a marker block placed on the patients chest. The main difference is that the LVS is obtaining the motion from the couch mounted video camera (otherwise known as the Liver View camera) whereas the RPM system uses a wall mounted dedicated infrared camera to obtain the patients breathing motion.
Data will be collected from patients that are already being treated using the RPM system as well as other patients who are receiving radiation therapy treatment.
For those patients where the RPM system is already being used in the patients treatment, data will be collected on both the RPM and LVS system during their treatment and will not take any additional time for the patient. Patients will be monitored for approximately 5 to 10 minutes for each patient.
If breath-hold-gating is not required as a part of the patients treatment, this cohort of patients will be asked to participate in a session separate from their treatment where their breathing can be monitored over a short period of time, providing data from both the LVS and RPM systems.
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Intervention code [1]
321582
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Not applicable
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Comparator / control treatment
The RPM system is the control system and this is being compared to the LVS system.
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Control group
Active
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Outcomes
Primary outcome [1]
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Compare the accuracy of the real time position management system to the live view system by comparing the motion wave forms between the two systems..
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Assessment method [1]
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Timepoint [1]
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Cumulative data will be assessed after all data collection has been completed for all participants
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Secondary outcome [1]
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Evaluate the clinical feasibility of using the Live View System for breath-hold gating by the time comparison using the two systems, ease of use and user feedback from staff by collecting an issues register..
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Assessment method [1]
400348
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Timepoint [1]
400348
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Cumulative data will be assessed after all data collection has been completed for all participants. Data is collected at time of treatment and quantitatively analysed at the end of treatment by the technical team.
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Secondary outcome [2]
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Determine the confidence level, of the Live View System assessed by evaluation of the quantitative analysis generated by the two systems.
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Assessment method [2]
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Timepoint [2]
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Cumulative data will be assessed after all data collection has been completed for all participants. Data is collected at time of treatment and quantitatively analysed at the end of treatment by the technical team.
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Eligibility
Key inclusion criteria
Patients over the age of 18 treated at Icon Cancer Centre on the Varian Halcyon machine for any indication to receive radiation therapy treatment..
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Patients unable to provide consent
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Study design
Purpose
Natural history
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Duration
Cross-sectional
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Selection
Convenience sample
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Withdrawn
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Reason for early stopping/withdrawal
Other reasons/comments
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Other reasons
Study withdrawn prior to activation due to change in technology. Study no longer required.
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Date of first participant enrolment
Anticipated
1/03/2024
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Actual
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Date of last participant enrolment
Anticipated
30/12/2024
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Actual
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Date of last data collection
Anticipated
30/11/2024
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Actual
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Sample size
Target
32
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment postcode(s) [1]
35206
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3058 - Moreland
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Recruitment postcode(s) [2]
35207
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2250 - Gosford
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Funding & Sponsors
Funding source category [1]
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Charities/Societies/Foundations
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Name [1]
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Icon Cancer Foundation
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Address [1]
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Level 1/22 Cordelia St, South Brisbane QLD 4101
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Country [1]
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Australia
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Funding source category [2]
309794
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Commercial sector/Industry
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Name [2]
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Varian Medical Systems
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Address [2]
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3120 Hansen Way Palo Alto California 94304 USA
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Country [2]
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United States of America
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Primary sponsor type
Charities/Societies/Foundations
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Name
Icon Cancer Foundation
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Address
Level 1/22 Cordelia St, South Brisbane QLD 4101
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
310577
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Address [1]
310577
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Country [1]
310577
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
309346
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Bellberry Human Research Ethics Committee
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Ethics committee address [1]
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123 Glen Osmond Road, Eastwood, South Australia 5063
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
309346
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27/11/2019
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Approval date [1]
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20/01/2020
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Ethics approval number [1]
309346
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2019-11-1040
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Summary
Brief summary
During radiation therapy treatment, some treatment machines have the ability to monitor a patients breathing patterns during treatment using a monitoring camera. A particular benefit of this treatment technique is for left sided breast patients as a deep breath (and hold) allows us to treat the breast cancer with reduced radiation dose to the heart. In this study, we are looking at whether the patient monitoring camera on the end of the Varian Halcyon treatment machine couch (called a Live View System (LVS)) can be used to monitor patients breathing during treatment. This will be compared to the currently used breathing motion camera called the Real-time Position Management (RPM) System. Who is it for? You may be eligible for this study if you are an adult receiving radiation therapy treatment at an Icon Cancer Centre. Study details We are aiming to recruit at least 16 patients (32 patients in total) at each participating site in order to determine the effectiveness of the new camera based system. Data will be collected from patients that are already being treated using the RPM system as well as other patients who are receiving radiation therapy treatment. This study will not impact the patients treatment in any way. For those patients where the RPM system is already being used in their treatment, data will be collected on both the RPM and LVS system during their treatment. The breath-hold-gating devices will collect the data during one daily treatment only and will not take any additional time for the patient. If breath-hold-gating is not required as a part of the patients treatment, they will be asked to participate, in a session separate from their treatment where their breathing can be monitored over a short period of time, providing data from both systems that can then be compared. It is intended that this research will contribute to the outcomes of patients by allowing motion management to be utilised on the Halcyon Linear Accelerator.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Mr Trent Aland
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Address
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Icon Group, Level 1/22 Cordelia St, South Brisbane QLD 4101
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Country
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Australia
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Phone
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+61 7 3453 0052
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Lloyd Smyth
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Address
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Icon Group, Level 1/22 Cordelia St, South Brisbane QLD 4101
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Country
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Australia
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Phone
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+61 7 37374500
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Trent Aland
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Address
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Icon Group, Level 1/22 Cordelia St, South Brisbane QLD 4101
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Country
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Australia
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Phone
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+61 7 3453 0052
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Fax
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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