Trial Review

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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
Scientific title
Breathing Motion Assessment on the Varian Halcyon Treatment Machine for Patients Receiving Radiation Therapy
Secondary ID [1] 305184 0
Nil
Universal Trial Number (UTN)
U1111-1269-1413
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 323458 0
Condition category
Condition code
Cancer 321008 321008 0 0
Any cancer

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 321582 0
Not applicable
Comparator / control treatment
The RPM system is the control system and this is being compared to the LVS system.
Control group
Active

Outcomes
Primary outcome [1] 328788 0
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..
Timepoint [1] 328788 0
Cumulative data will be assessed after all data collection has been completed for all participants
Secondary outcome [1] 400348 0
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..
Timepoint [1] 400348 0
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.
Secondary outcome [2] 401437 0
Determine the confidence level, of the Live View System assessed by evaluation of the quantitative analysis generated by the two systems.
Timepoint [2] 401437 0
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.

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..
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients unable to provide consent

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Study withdrawn prior to activation due to change in technology. Study no longer required.
Date of first participant enrolment
Anticipated
1/03/2024
Actual
Date of last participant enrolment
Anticipated
30/12/2024
Actual
Date of last data collection
Anticipated
30/11/2024
Actual
Sample size
Target
32
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment postcode(s) [1] 35206 0
3058 - Moreland
Recruitment postcode(s) [2] 35207 0
2250 - Gosford

Funding & Sponsors
Funding source category [1] 309567 0
Charities/Societies/Foundations
Name [1] 309567 0
Icon Cancer Foundation
Country [1] 309567 0
Australia
Funding source category [2] 309794 0
Commercial sector/Industry
Name [2] 309794 0
Varian Medical Systems
Country [2] 309794 0
United States of America
Primary sponsor type
Charities/Societies/Foundations
Name
Icon Cancer Foundation
Address
Level 1/22 Cordelia St, South Brisbane QLD 4101
Country
Australia
Secondary sponsor category [1] 310577 0
None
Name [1] 310577 0
Address [1] 310577 0
Country [1] 310577 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309346 0
Bellberry Human Research Ethics Committee
Ethics committee address [1] 309346 0
123 Glen Osmond Road, Eastwood, South Australia 5063
Ethics committee country [1] 309346 0
Australia
Date submitted for ethics approval [1] 309346 0
27/11/2019
Approval date [1] 309346 0
20/01/2020
Ethics approval number [1] 309346 0
2019-11-1040

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 113850 0
Mr Trent Aland
Address 113850 0
Icon Group, Level 1/22 Cordelia St, South Brisbane QLD 4101
Country 113850 0
Australia
Phone 113850 0
+61 7 3453 0052
Fax 113850 0
Email 113850 0
[email protected]
Contact person for public queries
Name 113851 0
Dr Lloyd Smyth
Address 113851 0
Icon Group, Level 1/22 Cordelia St, South Brisbane QLD 4101
Country 113851 0
Australia
Phone 113851 0
+61 7 37374500
Fax 113851 0
Email 113851 0
[email protected]
Contact person for scientific queries
Name 113852 0
Mr Trent Aland
Address 113852 0
Icon Group, Level 1/22 Cordelia St, South Brisbane QLD 4101
Country 113852 0
Australia
Phone 113852 0
+61 7 3453 0052
Fax 113852 0
Email 113852 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.