Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001232820
Ethics application status
Approved
Date submitted
4/11/2020
Date registered
13/09/2021
Date last updated
25/04/2024
Date data sharing statement initially provided
13/09/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Use of Siemens prototype sequences for Magnetic Resonance Imaging in radiation oncology
Scientific title
Feasibility and comparison of image quality of newly developed Siemens prototype sequences for Magnetic Resonance Imaging in radiation oncology
Secondary ID [1] 301778 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Siemens WIP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 318246 0
Condition category
Condition code
Cancer 316258 316258 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
As MRI sequence technology is being rapidly developed, there is also growth in prototype sequence development by MRI system vendors. These prototype sequences may provide added clinical benefit to radiotherapy patients. Our department has access to the latest prototype sequence developments through a master research agreement with Siemens Healthineers. These sequences are not yet available as clinical products, however they may prove to be of benefit for some patients, for example improved image quality within a faster imaging time.

This is a prospective feasibility and comparison study investigating the use of MRI prototype sequences for radiotherapy patients. Where there is an appropriate prototype sequence available, as determined by the treating clinician, patients already undergoing an MRI as part of their standard care prior to radiotherapy treatment will be recruited to undergo one or more prototype sequences in addition to the standard sequences. The additional prototype sequence(s) will occur after the standard MRI sequences are completed. A single or multiple prototype sequences may be performed as determined by clinician, within a time limit of 15 minutes. All sequences will be performed within the same scanning session. No additional study visits are required. No additional contrast will be given to participants for the purpose of the prototype sequences, they may however require contrast for their standard of care MRI scan.

The study sequences will be performed by the Radiation Oncology MRI staff, who will also ensure adherence to the intervention during the scan. The use of these sequences has the potential to provide additional imaging information and highlight particular pathology that improves treatment volume delineation for radiotherapy planning.
Intervention code [1] 318073 0
Treatment: Devices
Comparator / control treatment
current MRI practices
Control group
Active

Outcomes
Primary outcome [1] 324435 0
Composite image quality analysis of prototype sequences by assessing the contrast, noise and artefacts using image analysis software and visual assessment by the end user
Timepoint [1] 324435 0
After the MRI scan (standard + prototype sequences) is taken.
Primary outcome [2] 324436 0
Feasibility of implementing prototype sequences in standard practice as assessed by extra time requirements by review of scan time of prototype sequence(s) as recorded on scanner by MRI technician.
Timepoint [2] 324436 0
After all participants complete their scans.
Primary outcome [3] 328920 0
Feasibility of implementing prototype sequences in standard practice by a composite assessment of usefulness for treatment volume delineation and dosimetry plan as assessed by study survey of Radiation Oncologists and Radiation Therapists.
Timepoint [3] 328920 0
After all participants complete their scans.
Secondary outcome [1] 384641 0
Patient satisfaction with prototype MRI process sequence(s) in addition to standard radiotherapy planning MRI as assessed by documenting any concerns or discomfort at the time of scanning and feed back to study investigator.
Timepoint [1] 384641 0
After the MRI scan (standard + prototype sequences) is taken.

Eligibility
Key inclusion criteria
Any patient receiving radiotherapy that requires MRI for radiotherapy treatment planning purposes.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Any contraindication to MRI
- Age <18years
- Patient refusal
- Inability to provide informed consent

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
Standard clinical information will be extracted and de-identified from the clinical records to ensure appropriate understanding of the imaging and assessment of the impact on treatment of this imaging. A qualitative and/or quantitative comparison between the standard and prototype sequences will be undertaken by the treating clinician and the investigator team. An assessment of the impact of the availability of the prototype sequence on radiotherapy treatment and practice will be undertaken by the Liverpool and Macarthur research group as appropriate for the sequence being considered and the clinical site. This may include image quality analysis (e.g. contrast, noise, artefacts) and an assessment on the radiotherapy treatment planning process (e.g. comparison of treatment volumes used and radiation dosimetry plans)

Siemens will undertake an assessment on the image quality of the prototype sequences with a view to improve and adapt the prototype sequence to improve clinical applicability and benefits.

Data collected in this study will be stored perpetually and may be used for future research. The stored data will only be used in future research under the approval of a Human Research Ethics Committee.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/10/2021
Actual
18/10/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
250
Accrual to date
95
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 17079 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 17080 0
Campbelltown Hospital - Campbelltown
Recruitment postcode(s) [1] 30752 0
2170 - Liverpool
Recruitment postcode(s) [2] 30753 0
2560 - Campbelltown

Funding & Sponsors
Funding source category [1] 306209 0
Government body
Name [1] 306209 0
South Western Sydney Local Health District
Country [1] 306209 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] 306683 0
None
Name [1] 306683 0
Address [1] 306683 0
Country [1] 306683 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306420 0
South Western Sydney Local Health District
Ethics committee address [1] 306420 0
Ethics committee country [1] 306420 0
Australia
Date submitted for ethics approval [1] 306420 0
09/06/2021
Approval date [1] 306420 0
17/06/2021
Ethics approval number [1] 306420 0
2020/ETH02794

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

Contacts
Principal investigator
Name 103814 0
A/Prof Lois Holloway
Address 103814 0
Liverpool Hospital, 1 Campbell St, Liverpool NSW 2170
Country 103814 0
Australia
Phone 103814 0
+61 429094402
Fax 103814 0
+61 02 8738 9185
Email 103814 0
Lois.Holloway@health.nsw.gov.au
Contact person for public queries
Name 103815 0
Radiation Oncology Clinical Trials team
Address 103815 0
Ingham Institute, 1 Campbell St, Liverpool NSW 2170
Country 103815 0
Australia
Phone 103815 0
+61 429094402
Fax 103815 0
+61 02 8738 9185
Email 103815 0
SWSLHD-RadOncClinicalTrials@health.nsw.gov.au
Contact person for scientific queries
Name 103816 0
Robba Rai
Address 103816 0
Liverpool Hospital, 1 Campbell St, Liverpool NSW 2170
Country 103816 0
Australia
Phone 103816 0
+61 2 87389568
Fax 103816 0
+61 2 8738 9205
Email 103816 0
Robba.Rai@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


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.