Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000679583
Ethics application status
Approved
Date submitted
3/04/2024
Date registered
28/05/2024
Date last updated
28/05/2024
Date data sharing statement initially provided
28/05/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Optimising patient positioning for accelerated partial breast radiotherapy with the Integrated Magnetic Resonance Linear Accelerator
Scientific title
Optimising patient positioning for accelerated partial breast radiotherapy with the Integrated Magnetic Resonance Linear Accelerator
Secondary ID [1] 310749 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
OPRAH - MRL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Early Breast Cancer 331705 0
Condition category
Condition code
Cancer 328499 328499 0 0
Breast

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
After completing the standard of care planning MRI scans, participants will be asked to complete a short (10-15 mins) anonymous survey on an electronic platform to ask about their experience of the MRI scan and whether they have a preference for the supine or prone position. Participants will be asked to indicate their agreement with a statement on a Likert scale, and have the opportunity to provide answers to open- ended questions, There are no changes to standard treatments for participants.
Intervention code [1] 327519 0
Not applicable
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 336731 0
Quantification of image distortion in both the supine and prone positions to allow comparison and determine whether there is a patient or position specific difference.
Timepoint [1] 336731 0
Single timepoint post data collection from MRI simulation session.
Primary outcome [2] 337863 0
Measurement of relative distance from the Planning Target Volume (PTV) to the Organs At Risk (OAR) in the supine and prone positions.
Timepoint [2] 337863 0
Single timepoint post data collection on the same dataset from the MRI simulation session.
Primary outcome [3] 337864 0
Assessment of breathing motion for each patient in each position to determine whether this effect is more prominent in either position.
Timepoint [3] 337864 0
Single timepoint post data collection on the data from the MRI simulation session.
Secondary outcome [1] 433501 0
Assessment of dose differences (dose in Gray) to the target, organs at risk and normal tissue for each patient plan between the supine and prone positions on synthetic CTs generated from the MRI scans. This will be assessed as a composite secondary outcome.
Timepoint [1] 433501 0
Single timepoint post data collection on the data from the MRI simulation session.
Secondary outcome [2] 433502 0
Analyse survey responses (content analysis) to assess whether there is a patient preference for the supine or prone position.
Timepoint [2] 433502 0
Single timepoint, one survey will be completed directly after the MRI simulation appointment.

Eligibility
Key inclusion criteria
1. Eligible for accelerated partial breast radiotherapy as per the ASTRO favorable and Cautionary Guidelines
2. Informed consent

Minimum age
40 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Contraindications to MRI after screening
2. Patient unable to lay in treatment position for greater than 45 minutes
3. Patient unable to meet physical requirements of supine and prone scans

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
9/01/2024
Date of last participant enrolment
Anticipated
31/01/2025
Actual
Date of last data collection
Anticipated
31/01/2025
Actual
Sample size
Target
30
Accrual to date
4
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 314980 0
Other Collaborative groups
Name [1] 314980 0
ASMIRT Research Grant
Country [1] 314980 0
Australia
Primary sponsor type
Individual
Name
Jenna Dean, ONJ Centre, Austin Health
Address
Country
Australia
Secondary sponsor category [1] 318407 0
None
Name [1] 318407 0
Address [1] 318407 0
Country [1] 318407 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313953 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 313953 0
https://www.austin.org.au/Office-for-Research/
Ethics committee country [1] 313953 0
Australia
Date submitted for ethics approval [1] 313953 0
07/07/2023
Approval date [1] 313953 0
08/09/2023
Ethics approval number [1] 313953 0
HREC/100893/Austin-2023

Summary
Brief summary
The aim of this study is to compare the benefits and limitations of different positioning options for early breast cancer patients who are suitable for partial breast treatment on the Magnetic Resonance integrated Linac.

Who is it for?
You may be eligible for this study if you are a female age 40 or older, with early stage breast cancer and suitable for accelerated partial breast radiotherapy.

Study details
Participants will receive both a supine (on your back) and prone (on your tummy) scan in the MRI and a CT scan in the ideal treatment position (supine OR prone) as per our usual standard of care. Participants will then be asked to complete a short (10-15 mins) anonymous survey on an electronic platform to ask about their experience of the MRI scan and whether they have a preference for the supine or prone position. There are no changes to standard treatments for participants.

It is hoped that the findings from this study will streamline the simulation process for APBI patients and help us to determine who would benefit from which position without needing to complete both scans. It is also hoped that this information can be used across our other treatment machines to benefit patients who may not be able to have an MRI scan to work out the best position for them.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 129906 0
Miss Jenna Dean
Address 129906 0
Olivia Newton-John Cancer Centre, 145 Studley Rd, Heidelberg, Vic, 3084
Country 129906 0
Australia
Phone 129906 0
+613 94962800
Fax 129906 0
Email 129906 0
jenna.dean@austin.org.au
Contact person for public queries
Name 129907 0
Jenna Dean
Address 129907 0
Olivia Newton-John Cancer Centre, 145 Studley Rd, Heidelberg, Vic, 3084
Country 129907 0
Australia
Phone 129907 0
+613 94962800
Fax 129907 0
Email 129907 0
jenna.dean@austin.org.au
Contact person for scientific queries
Name 129908 0
Jenna Dean
Address 129908 0
Olivia Newton-John Cancer Centre, 145 Studley Rd, Heidelberg, Vic, 3084
Country 129908 0
Australia
Phone 129908 0
+613 94962800
Fax 129908 0
Email 129908 0
jenna.dean@austin.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.