ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12618000676213

Ethics application status

Approved

Date submitted

28/03/2018

Date registered

26/04/2018

Date last updated

1/06/2022

Date data sharing statement initially provided

26/07/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

A Participant Rotation Magnetic Resonance Imaging Study

Scientific title

A non-randomised study investigating the use and compliance of a participant rotation device on healthy volunteers and cancer patients during magnetic resonance imaging acquisition

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

PAROT

Linked study record

Health condition

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

Any Cancer

Condition category

Condition code

Cancer

Any cancer

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

To quantify anatomical deformations due to horizontal rotation and to assess participant acceptance of rotation within an MRI imaging system.
A 3 Tesla dedicated radiotherapy MRI scanner will be used to acquire the images. Images will be acquired using two scans: a higher quality ‘SPACE’ 3D isotropic T2-weighted turbo spin echo sequence at the zero degree couch position (TE=102 ms, TR=1470 ms, turbo factor=15, bandwidth 780Hz/pixel, slice thickness=1.7 mm) and a faster 2D T2-weighted turbo spin echo sequence for the images at varying couch angles (TE=96 ms, TR=8280 ms, turbo factor 15, slice thickness 4 mm, bandwidth 400Hz/pixel).
A one off MRI imaging session which takes 2 hours at most including set-up, imaging and set-down.
Participants will be divided between varying anatomical sites including but not limited to Cervix, Prostate, Head and Neck, Thorax
Radiologist with Investigator assistance will administer the intervention

Intervention code [1]

Treatment: Devices

Comparator / control treatment

No Control group.
Healthy volunteers will form the initial recruitment for this study. Then cancer patients will be recruited.
Recruitment for healthy volunteers will be open from 26/4/2018.
Recruitment for patients will open approximately 1 year after i.e 1/6/2019.

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Internal organ motion assessed by automated segmentation methods and structure comparison metrics including the dice similarity coefficient, volume, Hausdorff distance and centroid positions.

Timepoint [1]

Approximately 1 week after image analysis

Primary outcome [2]

Internal organ deformation assessed by automated segmentation methods and structure comparison metrics including the dice similarity coefficient, volume, Hausdorff distance and centroid positions.

Timepoint [2]

Approximately 1 week after image analysis

Secondary outcome [1]

To assess participant acceptance of rotation within an MRI imaging system.This outcome will be assessed by analysing the completed CLQ, STAI, FMS and Participant comfort questionnaires conducted pre and post imaging.

Timepoint [1]

After focus group sessions occurring 1 month after MRI

Secondary outcome [2]

To assess participant safety and efficacy of rotation within an MRI imaging system.This outcome will be assessed by analysing the completed CLQ, STAI, FMS and Participant comfort questionnaires conducted pre and post imaging.

Timepoint [2]

After focus group sessions occurring 1 month after MRI

Eligibility

Key inclusion criteria

1. Greater than or equal to 18 years of age
2. Willing and able to comply with all study requirements
3. Must be able to read and understand English
4. Signed, written informed consent
5. Must fall within height of 190cm, width and depth of 32cm x 45cm and weight limits of 100kg max the participant rotation system
6. Completed MRI safety screening form

Inclusion Criteria for Cancer Participant Volunteers
1. A current or previous diagnosis of cancer, any stage
2. Must have sufficient mobility to get into/out of the participant rotation system, as determined by the clinical investigator
3. Currently or previously being treated with radiotherapy

Inclusion Criteria for Healthy Volunteers
1. Current Staff member of Liverpool Hospital or Ingham Institute or University Student

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

1. Pregnant women
2. Mentally impaired participants or participants for whom attaining informed consent would be difficult (including language barriers)
3. Unable to undergo an MRI examination or has MRI contraindications
4. Participants who have been clinically diagnosed with severe claustrophobia

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

Who is / are masked / blinded?

Intervention assignment

Single group

Other design features

Phase

Not Applicable

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Patient acceptability will be assessed by analysing the completed CLQ, STAI, FMS and Participant comfort questionnaires conducted pre and post imaging. Any medically related issues will be consulted with the attending physician. All significant adverse events related to the intervention will be reported to the ethics committee immediately for appropriate review and action before continuing the study.

Recruitment

Recruitment status

Stopped early

Data analysis

Data collected is being analysed

Reason for early stopping/withdrawal

Participant recruitment difficulties
Other reasons/comments

Other reasons

Recruitment was paused from 22/12/21 and plans to resume were cancelled as enough data was collected, and rotating couch being trialled in this study no longer a main focus for the MRI research team.

Date of first participant enrolment

Anticipated

1/01/2019

Actual

14/06/2019

Date of last participant enrolment

Anticipated

16/04/2021

Actual

17/05/2021

Date of last data collection

Anticipated

30/04/2021

Actual

17/05/2021

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Liverpool Hospital - Liverpool

Recruitment postcode(s) [1]

2170 - Liverpool

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Liverpool Cancer Therapy Centre

Address [1]

Locked Bag 7103
Liverpool BC
NSW 1871

Country [1]

Australia

Primary sponsor type

Hospital

Name

Liverpool Hospital

Address

Locked Bag 7103
Liverpool BC
NSW 1871

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

South Western Sydney Local Health District Human Research Ethic Committee

Ethics committee address [1]

Locked Bag 7103, LIVERPOOL BC, NSW, 1871

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

30/10/2017

Approval date [1]

15/01/2018

Ethics approval number [1]

HREC/17/LPOOL/461

Summary

Brief summary

Background:
Current radiation therapy requires a radiation beam to be rotated around a patient. An alternative approach is to rotate a patient while the radiation beam remains stationary. Such a system may greatly reduce the costs of radiation therapy and would simplify the incorporation of radiation therapy with Magnetic Resonance Imaging (MRI), which would allow therapists to deliver treatment with greater precision.
Since this approach has never been utilised for either radiation therapy or in combination with MRI, the acceptance of the rotation to cancer patients is not known. It is also unclear how this rotation will impact the position and shape of the body’s internal organs and subsequently on the radiation therapy. The rotation will have no impact on the organ functions.
This study aims to bring patient rotation in MRI closer to reality, which would reduce the costs and complexity of radiation therapy.
The participant rotation device used for this study is not a medically approved device. All other devices used in the study, including the MRI, are medically approved.
Who is this for?
You may be eligible for this study if you have a current or previous diagnosis of cancer.
Study Details:
The study will be discussed with you at the time of your clinic appointment or prior to the MRI imaging session. You will have the opportunity to discuss the study with a qualified physician. Written informed consent will be obtained prior to registration on the study and before any assessments are performed.
Prior to the MRI imaging, you will be asked to complete a questionnaire, where you will be required to rate your current levels of anxiety, claustrophobia and motion sickness. The questionnaire will take approximately 5 minutes to complete.
During the imaging session, you will be asked to lie down on the couch on your back, supported by cushions under your back, head and knees. You will then be fastened with belts around the legs, across the chest and across the forehead and will be made as secure as possible without causing discomfort. Once you are comfortable, three inflatable air-cushions will be placed around you, the air cushions will then be inflated to support the weight of your body and restrict movement during the rotation. You will then be inserted into the MRI by the clinical investigators. They will then manually rotate the device to 45 degrees, and reposition you back in the MRI bore for each scan. The device will not rotate during the imaging.The whole imaging session should last approximately 40 minutes. You will be monitored constantly during the study in addition to holding a distress buzzer. Following the imaging, you will again be asked to complete the questionnaire to assess any change in your levels of anxiety and motion sickness. At the end of the session you will be asked a series of open ended questions relating to your experience. The full session will take 2 hours.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Lois Holloway

Address

Lois Holloway – Radiation Oncology Physics Unit
Locked Bag, 7103, Liverpool BC, NSW 1871.

Country

Australia

Phone

+61 2 87389148

Fax

+61 2 98285299

[email protected]

Contact person for public queries

Name

Penny Phan - Radiation Oncology Clinical Trials Unit

Address

Penny Phan – Radiation Oncology Clinical Trials Unit
Locked Bag, 7103, Liverpool BC, NSW 1871.

Country

Australia

Phone

+61 2 8738 9148

Fax

+61 2 8738 9205

[email protected]

Contact person for scientific queries

Name

Jarryd Buckley

Address

Centre for Medical and Radiation Physics
Building 15 - Room 113
University of Wollongong
Northfields Avenue
Gwynneville
NSW
2500

Country

Australia

Phone

+ 61 2 4221 8177

Fax

+61 2 8738 9205

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

Data will be analysed to show trends within the cohort

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

Source	Title	Year of Publication	DOI
Embase	Pelvic organ motion and dosimetric implications during horizontal patient rotation for prostate radiation therapy.	2021	https://dx.doi.org/10.1002/mp.14579

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically