Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12616000841471
Ethics application status
Approved
Date submitted
5/04/2016
Date registered
28/06/2016
Date last updated
10/09/2019
Date data sharing statement initially provided
10/09/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
A pilot study involving pre-surgery breast Magnetic resonance Imaging (MRI) for target volume delineation for breast- conserving radiation therapy
Scientific title
Pre-surgery MRI for target volume delineation in breast-conserving therapy: A pilot study
Secondary ID [1] 288928 0
Nil known
Universal Trial Number (UTN)
U1111-1181-5576
Trial acronym
Pre-Surgery Breast MRI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 298270 0
Condition category
Condition code
Cancer 298410 298410 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention involved in this study is the introduction of a pre-surgery breast MRI as comparison to the standard of no pre-surgery imaging to guide radiation oncologists in determining radiotherapy treatment volumes. Currently the standard of care is to use CT images. This study will compare the use of MRI with this standard of CT. Patient treatment will still be based on the CT images and there will be no changes to the standard treatment practice. The MRIs will be undertaken on two occasions if the participant is not having chemotherapy (within approximately one week prior to surgery and then at the same time as planning imaging for radiotherapy treatment) as part of their standard treatment or three times if the participant is having chemotherapy (within approximately one week prior to surgery, within approximately one week post-surgery and then at the same time as planning imaging for radiotherapy treatment). Two MRI scans will be performed on each occasion with the participant lying on their back (supine) for one scan then lying on their front (prone) for the other scan. The MRI scan will take approximately 60 minutes. Contrast will only be administered for the pre-surgery prone scan. The MRIs will be undertaken by clinical MRI and radiotherapy staff with expertise required for clinical use of this imaging modality. Definition of the target volumes on the MRIs will be undertaken by radiation oncologists, radiologists and radiation therapists familiar with breast cancer treatment volumes.
These images will not be used for clinical treatment planning during the course of this study.
Intervention code [1] 294413 0
Treatment: Other
Comparator / control treatment
There will not be a control group per say. The volumes determined on the MRI datasets will be compared with the volumes determined on the current clinical standard of CT images which are taken for standard care.
Control group
Active

Outcomes
Primary outcome [1] 297904 0
To assess the feasibility of deformable image registration between pre-surgery MRI and post-surgery MRI. This will be assessed by comparing differences in the radiotherapy treatment planning volumes and associated treatment plans when this extra ( pre-surgery) imaging information is available compared to the standard approach when this information is not available. This comparison will be undertaken for the purpose of this study and standard department processes will be used for radiotherapy treatment.
Timepoint [1] 297904 0
At time of radiotherapy planning
Primary outcome [2] 297905 0
To quantify the variability between pre-surgery and post-surgery target volumes. This will be assessed by comparison of differences in the radiotherapy treatment planning volumes and associated treatment plans generated for the purpose of this study with standard radiotherapy treatment processes. This will be done by direct plan comparison using the radiotherapy treatment planning system.
Timepoint [2] 297905 0
At time of radiotherapy planning
Secondary outcome [1] 322587 0
To compare the difference in image quality between supine and prone MRI scans for pre-surgery and post-surgery scans. This will be assessed by comparing both qualitative and quantitative metrics on image quality comparing the different imaging datasets. This will be done by comparing the signal to noise, uniformity and distortion for prone and supine MRIs.
Timepoint [1] 322587 0
At time of radiotherapy planning

Eligibility
Key inclusion criteria
Aged 18 years or older
Clinical T1-T2, N0 staged breast cancer
Scheduled for breast conserving surgery
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
History of ipsilateral breast cancer
Contra-indications for MRI e.g. ferromagnetic materials within the patient, claustrophobia
Receiving neoadjuvant treatment

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
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
Actual
9/05/2016
Date of last participant enrolment
Anticipated
3/12/2019
Actual
5/09/2017
Date of last data collection
Anticipated
Actual
6/09/2017
Sample size
Target
10
Accrual to date
Final
6
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 5566 0
Liverpool Hospital - Liverpool
Recruitment postcode(s) [1] 13024 0
2170 - Liverpool

Funding & Sponsors
Funding source category [1] 293293 0
Hospital
Name [1] 293293 0
Liverpool Cancer Services Trust Fund
Country [1] 293293 0
Australia
Primary sponsor type
Individual
Name
Lois Holloway
Address
Liverpool Hospital
Corner of Elizabeth and Goulburn Sts
Liverpool
New South Wales 2170, Australia
Country
Australia
Secondary sponsor category [1] 292094 0
None
Name [1] 292094 0
Address [1] 292094 0
Country [1] 292094 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294767 0
South Western Sydney Local Health District
Ethics committee address [1] 294767 0
Research and Ethics Office
Locked Bag 7103
Liverpool BC
NSW 2871
Ethics committee country [1] 294767 0
Australia
Date submitted for ethics approval [1] 294767 0
06/07/2015
Approval date [1] 294767 0
27/08/2015
Ethics approval number [1] 294767 0
HREC/15/LPOOL/299

Summary
Brief summary
This study aims to provide proof of principle for the use of pre-surgery breast MRI to guide radiation oncologists in determining radiotherapy treatment volumes.
Who is it for? You may be eligible to join this study if you are a female aged 18 years or more and have an early stage breast cancer and are scheduled to undergo breast conserving surgery at Liverpool Hospital, NSW.
Study details The study will involve participants completing MRI scans in the supine and prone positions and as per their routine care, will also undergo routine radiotherapy planning CT scans. These scans will be performed before surgery, after surgery and before radiotherapy for patients that are also receiving chemotherapy treatment. These images will be used to compare treatment volumes used to determine where the radiation is delivered generated based on the MRI information and based on the standard of care the CT information. Standard practice will be used for treatment, that is treatment volumes will be based on CT with no change in standard practice. It is hoped that this study will provide a proof of principle that pre-surgery MRI can be used to guide radiation oncologists in determining radiotherapy treatment volumes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 64926 0
A/Prof Lois Holloway
Address 64926 0
Dept Radiation Oncology and Ingham Institute
South Western Sydney Cancer Services
Locked Bag 7103
Liverpool BC NSW 1871
Country 64926 0
Australia
Phone 64926 0
+61 (0)2 87389218
Fax 64926 0
+61 (0)2 98285299
Email 64926 0
[email protected]
Contact person for public queries
Name 64927 0
A/Prof Lois Holloway
Address 64927 0
Liverpool Hospital
Corner of Elizabeth and Goulburn Sts
Liverpool
New South Wales 2170, Australia
Country 64927 0
Australia
Phone 64927 0
+61 (0)2 87389218
Fax 64927 0
+61 (0)2 98285299
Email 64927 0
[email protected]
Contact person for scientific queries
Name 64928 0
A/Prof Lois Holloway
Address 64928 0
South Western Sydney Cancer Services
Locked Bag 7103
Liverpool BC NSW 1871
Country 64928 0
Australia
Phone 64928 0
+61 (0)2 87389218
Fax 64928 0
+61 (0)2 98285299
Email 64928 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This trial closed on 20/03/19 due to lack of recruitment. No data analysis occurred.


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.