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Trial registered on ANZCTR


Registration number
ACTRN12621000418875
Ethics application status
Approved
Date submitted
9/10/2020
Date registered
15/04/2021
Date last updated
31/10/2022
Date data sharing statement initially provided
15/04/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
MRI-Linac treatment for radiotherapy patients. A study on the use of the Australian MRI-Linac to treat cancer radiotherapy patients
Scientific title
MAnTRA: Mri-linAc Treatments for Radiotherapy Patients. A Pilot study on the use of the Australian MRI –Linac to Treat Cancer Radiotherapy Patients.
Secondary ID [1] 301774 0
Nil known
Universal Trial Number (UTN)
Trial acronym
MANTRA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer requiring palliative radiotherapy 318239 0
Condition category
Condition code
Cancer 316251 316251 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Integrated Magnetic Resonance Imaging Linear Accelerators (MRI-Linacs) are one of the newest and most technologically advanced forms of cancer radiotherapy. This study tests the feasibility of the bespoke Australian MRI-Linac to treat cancer patients. It is an imaging and treatment intervention study. The machine is located at Liverpool Hospital and eligible patients will be recruited from Liverpool and Macarthur Cancer Therapy Centres.

Consenting patients will first have a radiotherapy CT and MRI simulation per standard of care, followed by a simulation on the MRI-Linac performed by trained MRI radiographer and radiation therapist. From this, a MRI-Linac treatment plan will be generated alongside a standard of care (SOC) treatment plan. These are planned by qualified radiation therapists and physicists, and approved by a radiation oncologist. Treatment contours, doses to organs at risk, and dose prescription will be consistent with standard departmental procedures.

Prior to starting treatment, participants will have a non-treatment session on the MRI-Linac, to perform patient-specific imaging, set-up quality assurance (QA) and to assess their tolerance of the procedure and the feasibility of the set-up. If deemed feasible, treatment will proceed on the MRI-Linac. One attempt will be made to remedy any unsuccessful treatment fraction – if this cannot be remedied then the patient will be treated with the SOC plan.

During each MRI Linac session, participants will be asked to lie down on the MRI Linac table and positioned inside the MRI Linac. Once inside, a series of MRI scans will be taken. Participants may require some support devices designed to maintain position during the scan and participants may be asked to be in different positions during the scan.

All participants will need to attend a minimum of two 1-hour sessions where the MRI-Linac machine will be used to guide radiotherapy treatments. Each session may be from 1 to 7 days apart. If treatment is feasible and each fraction is successfully treated on the MRI-Linac, participants will continue to have their treatment on the MRI-Linac until all of their prescribed treatment fractions are completed. The maximum treatment sessions participants will have on the MRI-Linac is therefore the amount of prescribed fractions per standard of care.
Intervention code [1] 318067 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 324431 0
Feasibility will be assessed by quantifying the proportion of patients for whom treatment is successfully conducted. If 6 or more out of 10 patients complete all of their treatment sessions on the MRI-Linac, then we will have demonstrated feasibility. If 5 or fewer out of 10 patients complete all of their treatment sessions then we will conclude that MRI-Linac radiotherapy is not currently feasible with the Australian MRI-Linac device. All relevant records will be noted in the patients’ medical records, including whether treatment was fully or partially completed on the MRI-Linac.
Timepoint [1] 324431 0
Feasibility will be assessed after all participants have either attempted or fully completed their treatment sessions on the MRI-Linac, prior to study closure.
Secondary outcome [1] 384615 0
Assess MRI-Linac process. This includes workflow, suitability of patient immobilisation, image guidance and adaptation strategies. These components will be physically assessed by the treating team with consideration to patient comfort, treatment reproducibility and MRI-Linac restrictions during each treatment session. An assessment log will keep track of treatment time, interlocks, equipment used and challenges faced for each treatment session.
Timepoint [1] 384615 0
After each treatment session on the MRI-Linac. Relevant records will be noted in patient's medical records.
Secondary outcome [2] 384616 0
Patient comfort as measured by a patient experience questionnaire using a visual analogue scale designed for this study.
Timepoint [2] 384616 0
After first and last treatment sessions on the MR-Linac for each participant.
Secondary outcome [3] 384617 0
Assess motion (tumour and/or patient motion) using intra-treatment MRI images
Timepoint [3] 384617 0
During patient treatment using intra-treatment MRI images.
Secondary outcome [4] 384618 0
Measure the changes in the tissues (anatomic and/or physiological) in the tumour tissue by comparing the images acquired before and during treatment for each treatment session
Timepoint [4] 384618 0
After each treatment session on the MRI-Linac.
Secondary outcome [5] 384621 0
Comparison of MRI-Linac plans with standard of care plans. This includes assessing dose distribution of both plans to target volumes and critical organs, and their QA dose calculation results.
Timepoint [5] 384621 0
Prior to radiotherapy treatment during radiotherapy planning.
Secondary outcome [6] 384622 0
Oncologic outcome which is a composite outcome of symptom response and acute radiotherapy toxicity. Physical clinical assessments of symptoms are performed by the radiation oncologist. Acute toxicity will be formally assessed according to the CTCAE scoring. All assessments are recorded in the patient's medical records.
Timepoint [6] 384622 0
After each treatment session, Also at follow up with the patient's attending oncologist at 2 weeks, 4 weeks, 3 months, and 6 months post-treatment.

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
- A diagnosis of cancer with a palliative indication for radiotherapy and referral to the Liverpool or Macarthur Cancer Therapy Centres
- A treatment site and prognosis that, in the opinion of the treating physician, is clinically appropriate for this MRI-Linac feasibility trial using conformal radiotherapy in consultation with medical physicists and radiation therapists. The treatment fields used for planning must be able to be accommodated for the particular patient on the MRI-Linac. Examples may include (but are not restricted to) patients presenting with:
- Cervical-spine metastasis
- Whole brain
- Recurrent brain metastasis
- Bone metastasis
- Soft tissue metastasis
- ECOG status 0-2
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Pain in the treatment position.
- Resources not available to reasonably expect to commence treatment within two weeks of consent
- Patient unable to physically fit into the MRI-Linac patient treatment space
- Contraindication to MRI as according to departmental protocol.
- Contraindication to standard radiation therapy
- Pregnant women

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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Sample size of 10 patients is based on the pragmatics of recruitment and the necessities for examining feasibility. 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
30/11/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 17075 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 17076 0
Campbelltown Hospital - Campbelltown
Recruitment hospital [3] 17077 0
Bankstown-Lidcombe Hospital - Bankstown
Recruitment postcode(s) [1] 30748 0
2170 - Liverpool
Recruitment postcode(s) [2] 30749 0
2560 - Campbelltown
Recruitment postcode(s) [3] 30750 0
2200 - Bankstown

Funding & Sponsors
Funding source category [1] 306204 0
Government body
Name [1] 306204 0
National Health and Medical Research Council
Country [1] 306204 0
Australia
Funding source category [2] 306208 0
Hospital
Name [2] 306208 0
Liverpool Cancer Therapy Centre
Country [2] 306208 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] 306682 0
None
Name [1] 306682 0
Address [1] 306682 0
Country [1] 306682 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306416 0
Bellberry Limited
Ethics committee address [1] 306416 0
Ethics committee country [1] 306416 0
Australia
Date submitted for ethics approval [1] 306416 0
01/10/2020
Approval date [1] 306416 0
03/11/2020
Ethics approval number [1] 306416 0
2020/ETH02208

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

Contacts
Principal investigator
Name 103798 0
Dr Trang Pham
Address 103798 0
Ingham Institute, 1 Campbell St, Liverpool NSW 2170
Country 103798 0
Australia
Phone 103798 0
+61 2 87389148
Fax 103798 0
+61 2 87389205
Email 103798 0
trang.pham@health.nsw.gov.au
Contact person for public queries
Name 103799 0
Penny Phan
Address 103799 0
Ingham Institute, 1 Campbell St, Liverpool NSW 2170
Country 103799 0
Australia
Phone 103799 0
+61 2 87389148
Fax 103799 0
+61 2 87389205
Email 103799 0
penny.phan@health.nsw.gov.au
Contact person for scientific queries
Name 103800 0
Trang Pham
Address 103800 0
Ingham Institute, 1 Campbell St, Liverpool NSW 2170
Country 103800 0
Australia
Phone 103800 0
+61 2 87389148
Fax 103800 0
+61 2 87389205
Email 103800 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 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.