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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
26/07/2019
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] 294464 0
Nil known
Universal Trial Number (UTN)
Trial acronym
PAROT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Any Cancer 307221 0
Condition category
Condition code
Cancer 306335 306335 0 0
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] 300757 0
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] 305346 0
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] 305346 0
Approximately 1 week after image analysis
Primary outcome [2] 305644 0
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] 305644 0
Approximately 1 week after image analysis
Secondary outcome [1] 344928 0
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] 344928 0
After focus group sessions occurring 1 month after MRI
Secondary outcome [2] 346016 0
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] 346016 0
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
Gender
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
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 10517 0
Liverpool Hospital - Liverpool
Recruitment postcode(s) [1] 22231 0
2170 - Liverpool

Funding & Sponsors
Funding source category [1] 299087 0
Hospital
Name [1] 299087 0
Liverpool Cancer Therapy Centre
Address [1] 299087 0
Locked Bag 7103
Liverpool BC
NSW 1871
Country [1] 299087 0
Australia
Primary sponsor type
Hospital
Name
Liverpool Hospital
Address
Locked Bag 7103
Liverpool BC
NSW 1871
Country
Australia
Secondary sponsor category [1] 298337 0
None
Name [1] 298337 0
Address [1] 298337 0
Country [1] 298337 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300023 0
South Western Sydney Local Health District Human Research Ethic Committee
Ethics committee address [1] 300023 0
Locked Bag 7103, LIVERPOOL BC, NSW, 1871
Ethics committee country [1] 300023 0
Australia
Date submitted for ethics approval [1] 300023 0
30/10/2017
Approval date [1] 300023 0
15/01/2018
Ethics approval number [1] 300023 0
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 82294 0
A/Prof Lois Holloway
Address 82294 0
Lois Holloway – Radiation Oncology Physics Unit
Locked Bag, 7103, Liverpool BC, NSW 1871.
Country 82294 0
Australia
Phone 82294 0
+61 2 87389148
Fax 82294 0
+61 2 98285299
Email 82294 0
lois.holloway@health.nsw.gov.au
Contact person for public queries
Name 82295 0
Ms Penny Phan - Radiation Oncology Clinical Trials Unit
Address 82295 0
Penny Phan – Radiation Oncology Clinical Trials Unit
Locked Bag, 7103, Liverpool BC, NSW 1871.
Country 82295 0
Australia
Phone 82295 0
+61 2 8738 9148
Fax 82295 0
+61 2 8738 9205
Email 82295 0
SWSLHD-RadOncClinicalTrials@health.nsw.gov.au
Contact person for scientific queries
Name 82296 0
Mr Jarryd Buckley
Address 82296 0
Centre for Medical and Radiation Physics
Building 15 - Room 113
University of Wollongong
Northfields Avenue
Gwynneville
NSW
2500
Country 82296 0
Australia
Phone 82296 0
+ 61 2 4221 8177
Fax 82296 0
+61 2 8738 9205
Email 82296 0
jgb552@uowmail.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data will be analysed to show trends within the cohort
What supporting documents are/will be available?
No other documents available
Summary results
No Results