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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

8/12/2024

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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Cancer

Condition category

Condition code

Cancer

Lung - Non small cell

Cancer

Lung - Small cell

Cancer

Lung - Mesothelioma

Cancer

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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?

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

Recruiting

Date of first participant enrolment

Anticipated

4/12/2023

Actual

22/05/2024

Date of last participant enrolment

Anticipated

1/12/2025

Actual

Date of last data collection

Anticipated

24/12/2024

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Peter MacCallum Cancer Centre - Melbourne

Recruitment postcode(s) [1]

3000 - Melbourne

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Cancer Council Victoria

Address [1]

615 St Kilda Rd, Melbourne VIC 3004

Country [1]

Australia

Funding source category [2]

Charities/Societies/Foundations

Name [2]

The Peter MacCallum Foundation

Address [2]

305 Grattan St, Melbourne VIC 3000

Country [2]

Australia

Funding source category [3]

Hospital

Name [3]

The Peter MacCallum Centre

Address [3]

305 Grattan St, Melbourne VIC 3000

Country [3]

Australia

Primary sponsor type

Hospital

Name

The Peter MacCallum Centre

Address

305 Grattan St, Melbourne VIC 3000

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Peter MacCallum Cancer Centre Human Research Ethics Committee

Ethics committee address [1]

305 Grattan St, Melbourne VIC 3000

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

10/11/2022

Approval date [1]

06/09/2023

Ethics approval number [1]

Summary

Brief summary

This study is testing a new radiation therapy device, a rotating chair, as an alternative to the normal treatment position (lying down) for patients with either head and neck or lung cancer. The main purpose of this research is to find out if the images we take of patients seated in the radiation therapy chair are suitable for positioning a patient during radiation therapy, which is essential to ensure that the therapy can be delivered to the target area.


Who is it for?
You may be eligible for this study if you are aged 50 years or older, you have been scheduled to receive radiation therapy for either lung cancer or head and neck cancer, you are able to move into a sitting or a lying position independently and you are willing to have routine radiotherapy in the afternoon.


Study details
All patients who choose to enrol in this study will be asked to participate in three main sessions, a seated simulation session (30 minutes), a seated imaging session and questionnaire (approximately 60 minutes), and a follow up questionnaire (approximately 15 minutes). These sessions are in addition to a radiation simulation session and multiple radiation treatment sessions which are a part of usual care. 

During the seated sessions, participants will be asked to sit in the rotating radiation therapy chair. The chair is rotated by a small electric motor, in a similar motion to how an office chair rotates. Study participants will be rotated very slowly – it will take 1-2 minutes to do two full rotations. There will be no extra visits to the hospital if you choose to take part in this study, all additional sessions will be scheduled on days you would be attending hospital for usual care.

In the seated simulation session, we will introduce participants to the rotating radiation therapy chair. Our therapists will adjust the chair to a comfortable position and setup equipment to help keep participants still.

In the seated imaging session, we will take an image similar to a CT image (CAT scan) by rotating participants in the chair whilst taking a series of x-ray images. This image will be assessed to see if it is suitable for positioning patients for radiation therapy in the future. We will also take x-rays to test if a patient’s body position changes while sitting in the chair, and if we would be able to set a patient up in the same body for multiple treatments in the future. Participants will be interviewed about their experience of both lying down for routine treatment and sitting in the rotating chair. 

Patients will be interviewed with a follow-up questionnaire, after one of their routine radiation treatments near the end of their treatment course.


It is hoped this research will determine whether use of a rotating chair for radiation therapy is possible and whether this method of delivery is comfortable for participants. If this study demonstrates that is possible, a larger study to test treatment with the chair may occur in the future.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr James Korte

Address

Peter MacCallum Cancer Centre
Department of Physical Science
305 Grattan St, Melbourne VIC 3000

Country

Australia

Phone

+61 3 8559 5841

Fax

james.korte@petermac.org

Contact person for public queries

Name

Nicholas Hardcastle

Address

Peter MacCallum Cancer Centre
Department of Physical Science
305 Grattan St, Melbourne VIC 3000

Country

Australia

Phone

+61 3 8559 5000

Fax

nick.hardcastle@petermac.org

Contact person for scientific queries

Name

James Korte

Address

Peter MacCallum Cancer Centre
Department of Physical Science
305 Grattan St, Melbourne VIC 3000

Country

Australia

Phone

+61 3 8559 5000

Fax

james.korte@petermac.org

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 james.korte@petermac.org.

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

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No documents have been uploaded by study researchers.

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No additional documents have been identified.

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