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Trial registered on ANZCTR


Registration number
ACTRN12620000458932p
Ethics application status
Submitted, not yet approved
Date submitted
10/03/2020
Date registered
8/04/2020
Date last updated
8/04/2020
Date data sharing statement initially provided
8/04/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Australian MRI-Linac Patient Imaging Trial
Scientific title
Establishing imaging and treatment workflows for the treatment of difference cancer sites on the Australian MRI-Linac - A pilot study.
Secondary ID [1] 300758 0
Nil
Universal Trial Number (UTN)
Trial acronym
AMPI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer requiring radiation therapy treatment 316607 0
Condition category
Condition code
Cancer 314836 314836 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Eligible patients will receive two additional MRI scan sessions on the Australian MRI Linac. Each scan will take no more than one hour and separated by approximately 1 week from each other, depending on their treatment plan and other standard medical appointments they may have within the hospital. The imaging sessions will be conducted by MRI trained staff with qualified Radiation Therapist, Radiation Oncologist and Medical Physicist to assist where required. MRI gadolinium contrast may be given at MRI simulation during the scan if clinically indicated for the patients tumour site. The dose will be according to department standard practices.
Intervention code [1] 317088 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323188 0
To qualitatively assess the imaging acquired by the Australian MRI-Linac. A range of cancer sites will be examined and the quality of the MRI-Linac images will be assessed. The research team inclusive of a Radiation Oncologist, physicist, radiographer and radiation therapist will assess images and complete an evaluation form.
Timepoint [1] 323188 0
After each participant's second imaging session on the MRI-Linac.
Secondary outcome [1] 381408 0
Patient comfort and satisfaction will be assessed with using a Patient Satisfaction and comfort questionnaire. This is a composite outcome. The patient satisfaction and comfort questionnaire has been designed specifically for this study focusing on the the use of the Australian MRI-Linac. The questionnaire is titled 'Australian MRI-Linac Patient Experience Questionnaire'
Timepoint [1] 381408 0
After each scanning session on the MRI-Linac.

Eligibility
Key inclusion criteria
18 years or older
Have the ability to give informed consent with the clear understanding that this is a prototype cancer radiation therapy system and not a commercially available and supported system
Undergoing radiotherapy treatment at Liverpool or Macarthur Cancer Therapy Centres
Patients presenting with the following tumour treatment sites but not limited to: Bone metastases, Breast cancer, CNS cancer (including glioma, brain metastases), Gastrointestinal cancer (including pancreatic, liver, oesophageal and rectal cancer), Gynaecological cancer (including cervix),Head and neck cancer, Lung cancer, Prostate cancer, Renal cancer,
ECOG status 0-2
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pain or discomfort in MRI-Linac simulation positions.
Patient unable to physically fit into the MRI-Linac patient treatment space or MRI Simulator
Contraindication to standard radiation therapy
Contraindicated for MRI as according to departmental policy.
Pregnant women

Study design
Purpose of the study
Educational / counselling / training
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
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
For each disease treatment site, imaging, patient setup and workflows will be developed based on the acquired images and patient feedback data. Workflows will be assessed by clinical staff for acceptability based on standard of care.

Recruitment
Recruitment status
Not yet 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] 16105 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 16106 0
Campbelltown Hospital - Campbelltown
Recruitment hospital [3] 16107 0
Bankstown-Lidcombe Hospital - Bankstown
Recruitment postcode(s) [1] 29620 0
2170 - Liverpool
Recruitment postcode(s) [2] 29621 0
2560 - Campbelltown
Recruitment postcode(s) [3] 29622 0
2200 - Bankstown

Funding & Sponsors
Funding source category [1] 305218 0
Government body
Name [1] 305218 0
National Health and Medical Research Council
Address [1] 305218 0
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Country [1] 305218 0
Australia
Primary sponsor type
Government body
Name
South Western Sydney Local Health District
Address
Cnr of Goulburn and Elizabeth Streets, Liverpool Hospital, Liverpool, NSW 2170
Country
Australia
Secondary sponsor category [1] 305577 0
None
Name [1] 305577 0
Address [1] 305577 0
Country [1] 305577 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 305566 0
South Western Sydney Local Health District
Ethics committee address [1] 305566 0
Cnr of Goulburn and Elizabeth Streets, Liverpool, NSW 2170
Ethics committee country [1] 305566 0
Australia
Date submitted for ethics approval [1] 305566 0
14/01/2020
Approval date [1] 305566 0
Ethics approval number [1] 305566 0

Summary
Brief summary
The purpose of this study is to try out a new imaging machine, called Integrated Magnetic Resonance Imaging Linear Accelerators (MRI-Linacs)

Who is it for?
You may be eligible for this study if you are aged 18 years or older and are undergoing radiation therapy for cancer at Liverpool or Macarthur Cancer Therapy Centres in Sydney.

Study details
All participants in this study will have two MRI-Linacs scans. The scans will be about a week apart, and involve lying still on on different positions depending on site of treatment within a confined doughnut like machine. In addition to the scans, participants will also answer questionnaires, consent to access medical records, You may require a dye injected through your viens to enhance image quality depending on the area you are having treatment to.

It is hoped this research will provide information to develop new imaging procedures on the Australian MRI-Linac. The data collected will be critical in developing future MRI Linac treatments on this device.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 100794 0
Dr Trang Pham
Address 100794 0
Ingham Institute, 1 Campbell St, Liverpool NSW 2170
Country 100794 0
Australia
Phone 100794 0
+61 2 87389148
Fax 100794 0
+61 2 87389205
Email 100794 0
trang.pham@health.nsw.gov.au
Contact person for public queries
Name 100795 0
Ms Penny Phan
Address 100795 0
Ingham Institute. 1 Campbell St, Liverpool NSW 2170
Country 100795 0
Australia
Phone 100795 0
+61 2 87389148
Fax 100795 0
+61 2 87389205
Email 100795 0
penny.phan@health.nsw.gov.au
Contact person for scientific queries
Name 100796 0
Dr Trang Pham
Address 100796 0
Ingham Institute, 1 Campbell St, Liverpool NSW 2170
Country 100796 0
Australia
Phone 100796 0
+61 2 87389148
Fax 100796 0
+61 2 87389205
Email 100796 0
trang.pham@health.nsw.gov.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 as a cohort and trends will be analysed.
What supporting documents are/will be available?
No other documents available
Summary results
No Results