Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000498695
Ethics application status
Approved
Date submitted
12/01/2023
Date registered
15/05/2023
Date last updated
30/10/2023
Date data sharing statement initially provided
15/05/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
An exploratory study of imaging in a seated position for radiation therapy patients with lung cancer or head and neck cancer
Scientific title
An exploratory phase 1 study of upright imaging in a seated position for radiation therapy patients with lung cancer or head and neck cancer using a rotating positioning system
Secondary ID [1] 308734 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 328679 0
Condition category
Condition code
Cancer 325685 325685 0 0
Lung - Non small cell
Cancer 325686 325686 0 0
Lung - Small cell
Cancer 325687 325687 0 0
Lung - Mesothelioma
Cancer 325688 325688 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Upright cone-beam computed tomography (uCBCT) images will be acquired of patients in a seated position using a rotating radiotherapy chair. The chair has been designed and built in-house to integrate with a conventional radiation therapy machine (LINAC). The on-board killo-voltage (kV) x-ray imaging system of the LINAC will be set in fluoroscopy mode to acquire a series of kV images as the patient is rotated through a full revolution. Volumetric (3D) images are then generated from the kV images using an image reconstruction algorithm

All study participants will be imaged in a seated position at a single timepoint, on the same day as a standard of care radiotherapy treatment fraction. A radiation therapist will control the radiotherapy chair and LINAC to acquire the kV images required to generate uCBCT images. All imaging will be performed in radiotherapy bunkers at the Parkville campus of Peter MacCallum Cancer Centre. The anticipated duration of the imaging session is 45 minutes. One the same day, during the standard of care treatment fraction, participants will also undergo routine CBCT imaging in the supine position.
Intervention code [1] 325200 0
Treatment: Devices
Comparator / control treatment
The uCBCT images of patients in a seated position will be compared to standard of care cone-beam computed tomography (CBCT) images of the patients in the supine (lying down) position. The uCBCT images will be taken on the same day as standard or care CBCT images, which are taken during a radiation treatment fraction.

High quality planning computed tomography (pCT) images of patients in the supine (lying down) position will also be used for image comparison. The pCT images are taken during a radiotherapy simulation session which occurs approximately 1-2 weeks prior to the first radiation treatment fraction. pCT images will be acquired with 100 ml iodinated intravenous contrast if clinically indicated. A standard of care radiation therapy simulation session will take approximately 30 to 60 minutes.
Control group
Active

Outcomes
Primary outcome [1] 333543 0
A composite of the similarity in geometry of solid structures and visibility of landmarks on cone-beam CT (CBCT) images for radiotherapy positioning of lung cancer and head and neck cancer (HNC) patients in the standard supine and upright (seated) positions. Assessed by the difference in geometry of solid structures (volume, size, surface distance, DICE overlap) and visibility of anatomical landmarks (visible/not visible) on CBCT images in the supine and upright positions, as compared to a treatment planning CT (pCT).
Timepoint [1] 333543 0
Seated and supine CBCT imaging will be conducted on the day of a radiation treatment fraction within the first two weeks of radiation treatment. The pCT imaging will occur during the radiation simulation session which is conducted up to approximately 2 weeks prior to the start of radiation treatment.
Secondary outcome [1] 417474 0
A comparison of patient experience in an upright and supine position. Assessed as a difference in patient experience questionnaire scores for upright and supine positions. The questionnaire will be administered as a face-to-face interview with a member of the research team. The questionnaire has been adapted, with permission of the original authors, from a questionnaire developed in a previous radiotherapy positioning study with the following details:

McCarroll, Rachel E., et al. "Reproducibility of patient setup in the seated treatment position: A novel treatment chair design." Journal of applied clinical medical physics 18.1 (2017): 223-229.
Timepoint [1] 417474 0
The patient experience questionnaire will be administered on the same day as a radiation treatment in the first two weeks of therapy, on the same day as the CBCT imaging session used for the primary endpoint.
Participants will be interviewed with the supine portion of the questionnaire following the routine radiation treatment fraction. Participants will be interviewed with the upright portion of the questionnaire during the upright CBCT imaging session.
Secondary outcome [2] 417475 0
Patient positioning will be assess as a composite of the stability and reproducibility of an upright position. Reported with mean intra-fractional and inter-fractional translation and rotation as measured on kilo-voltage (kV) planar x-ray imaging.
Timepoint [2] 417475 0
Imaging will be conducted on the same day as a radiation treatment in the first two weeks of therapy, in the same session as the CBCT imaging used for the primary endpoint.
Secondary outcome [3] 417476 0
A comparison of patient anatomy in an upright and supine position using cone-beam CT images. Assessed as a composite of the differences in relative position, volume and shape of tumour and organs at risk between upright and supine positions.
Timepoint [3] 417476 0
Imaging used to assess this outcome will be acquired on the same day as a radiation treatment in the first two weeks of therapy, as part of the imaging session used for the primary endpoint.
Secondary outcome [4] 417477 0
An evaluation of upright CBCT for the purposes of radiation therapy treatment planning. Assessed as a composite of the difference in geometry of solid structures and density of anatomical structures on uCBCT and pCT.
Timepoint [4] 417477 0
The CBCT imaging used to assess this outcome will be acquired on the same day as a radiation treatment in the first two weeks of therapy, as part of the imaging session used for the primary endpoint.

The pCT imaging used to assess this outcome will occur during the radiation simulation session which is conducted up to approximately 2 weeks prior to the start of radiation treatment.
Secondary outcome [5] 417478 0
A comparison of planned radiation treatment dose to critical organs between upright and supine positions. Assessed as a difference in radiation dose metrics to tumour and organs at risk between upright and supine positions. The radiation dose metrics will be calculated from the radiation therapy treatment plan.
Timepoint [5] 417478 0
An upright radiation therapy treatment plan will be created on the CBCT imaging what is acquired on the same day as a radiation treatment in the first two weeks of therapy, as part of the imaging session used for the primary endpoint.

The supine radiation therapy treatment plan will be created as part of clinical routine, following the radiation simulation session, which is conducted up to approximately 2 weeks prior to the start of radiation treatment, and before the start of radiation treatment..
Secondary outcome [6] 417479 0
An assessment of the use of surface cameras for upright patient positioning and stability monitoring during a simulated upright treatment. Reported as the similarity of intra-fractional and inter-fractional translation and rotation between surface cameras and kV planar imaging.
Timepoint [6] 417479 0
The surface camera data will be acquired on the same day as a radiation treatment in the first two weeks of therapy, during the imaging session used for the primary endpoint.

Eligibility
Key inclusion criteria
Age of 50 years or older
Scheduled to receive radiation therapy for either lung cancer (palliative) or head and neck cancer
Patient is capable of independent transfers
Patient is willing to have routine radiotherapy in afternoon
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to comply with the upright imaging position
Unable to tolerate slow rotation without experiencing greater than mild vertigo
Unable to maintain a supported seated position for at least 15 minutes
Does not meet the weight or height limitations of the upright device

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
As the primary goals is to investigate if upright imaging is possible, a pragmatic sample size of 20 has been selected. This exploratory study will include 10 patients with lung cancer and 10 patients with HNC. A sample size of 10 per group will allow us to estimate the difference in the geometry of solid structures or visibility of patient positioning landmarks with a 95% confidence interval of approximately 0.754 standard deviations. Given the novelty of the study, the standard deviations of each measure will not be known until measured in the study.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/12/2023
Actual
Date of last participant enrolment
Anticipated
1/07/2024
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 23819 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 39271 0
3000 - Melbourne

Funding & Sponsors
Funding source category [1] 312957 0
Charities/Societies/Foundations
Name [1] 312957 0
Cancer Council Victoria
Country [1] 312957 0
Australia
Funding source category [2] 312958 0
Charities/Societies/Foundations
Name [2] 312958 0
The Peter MacCallum Foundation
Country [2] 312958 0
Australia
Funding source category [3] 312959 0
Hospital
Name [3] 312959 0
The Peter MacCallum Centre
Country [3] 312959 0
Australia
Primary sponsor type
Hospital
Name
The Peter MacCallum Centre
Address
305 Grattan St, Melbourne VIC 3000
Country
Australia
Secondary sponsor category [1] 314648 0
None
Name [1] 314648 0
Address [1] 314648 0
Country [1] 314648 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312231 0
Peter MacCallum Cancer Centre Human Research Ethics Committee
Ethics committee address [1] 312231 0
Ethics committee country [1] 312231 0
Australia
Date submitted for ethics approval [1] 312231 0
10/11/2022
Approval date [1] 312231 0
06/09/2023
Ethics approval number [1] 312231 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 123922 0
Dr James Korte
Address 123922 0
Peter MacCallum Cancer Centre
Department of Physical Science
305 Grattan St, Melbourne VIC 3000
Country 123922 0
Australia
Phone 123922 0
+61 3 8559 5841
Fax 123922 0
Email 123922 0
[email protected]
Contact person for public queries
Name 123923 0
Nicholas Hardcastle
Address 123923 0
Peter MacCallum Cancer Centre
Department of Physical Science
305 Grattan St, Melbourne VIC 3000
Country 123923 0
Australia
Phone 123923 0
+61 3 8559 5000
Fax 123923 0
Email 123923 0
[email protected]
Contact person for scientific queries
Name 123924 0
James Korte
Address 123924 0
Peter MacCallum Cancer Centre
Department of Physical Science
305 Grattan St, Melbourne VIC 3000
Country 123924 0
Australia
Phone 123924 0
+61 3 8559 5000
Fax 123924 0
Email 123924 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
After data de-identification, all of the individual participant data collected during the trial may be made available to eligible and approved researchers.
When will data be available (start and end dates)?
Data may be made available on request within 15 years after publication of the study results (expected by 2025).
Available to whom?
Data will only be made available to researchers who provide a methodologically sound proposal, on case-by-case basis at the discretion of Principal Investigator and Human Research Ethics Committee.
Available for what types of analyses?
Data may only be made available to achieve the aims of an approved proposal.
How or where can data be obtained?
Expressions of interest relating to future data access can be made to the Principal Investigator. Please contact the principal investigator at [email protected].


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.