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Trial registered on ANZCTR
Registration number
ACTRN12613000725763
Ethics application status
Approved
Date submitted
21/06/2013
Date registered
1/07/2013
Date last updated
26/10/2018
Date data sharing statement initially provided
26/10/2018
Type of registration
Prospectively registered
Titles & IDs
Public title
Ultrasound visible breast markers: can these be used for preoperative ultrasound guided lesion localisation?
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Scientific title
Can any of six different ultrasound enhanced breast biopsy markers inserted in a randomised fashion after a stereotactic breast biopsy be well enough visualised using ultrasound on the day of surgery to act as a target for preoperative ultrasound guided lesion localisation with hookwire for surgical removal in theatre
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Secondary ID [1]
281017
0
Nil
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Universal Trial Number (UTN)
U1111-1144-7425
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Breast cancer
287152
0
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Preoperative image guided localisation of impalpable breast cancers to guide surgery
287301
0
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Condition category
Condition code
Cancer
287471
287471
0
0
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Breast
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Each participant will have one of six commercially available breast biopsy markers inserted following a stereotactic vacuum assisted core biopsy of one (or more) breast lesion(s).
A list of the six markers will be provided to the clinic staff. The order of the markers will be determined by random selection based upon a table of random numbers. They will then be used sequentially starting with the first randomly chosen marker on the list for the first lesion then the next lesion will receive the next marker on the list and so on. When each clip has been used twice a new randomisation will produce a new list and the same process will be repeated. This procedure will be used until sufficient numbers of subjects has been recruited. After clip selection the participant's ID and lesion number will be entered against the marker used on the list so that the next lesion (or participant, if the participant has only one lesion for stereotactic biopsy) will receive the next marker on the list and so on. The radiologist will not be allowed to "choose" which marker is used.
The insertion procedure is performed at the end of each stereotactic vacuum assisted biopsy and takes only a few minutes at most to perform.
The position of the marker will be checked on an immediate post biopsy mammogram (this is standard procedure) and the visibility of the marker and any post biopsy hematoma will be assessed on a targeted ultrasound immediately after the biopsy is completed (this is an addition to standard practice).
Participants whose biopsy results indicate that surgical removal of the lesion is required and who return to our hospital for surgery will have a further targeted ultrasound on the day of surgery, again to assess marker and hematoma visibility to see if preoperative hook-wire localisation can be successfully performed using ultrasound rather than stereotactic guidance (the metal component of each biopsy marker is always visible using mammography). If the marker or hematoma is not sufficiently visible using ultrasound, the hook-wire will be inserted using stereotactic guidance. A mammogram will be performed to assess position of the hookwire relative to the marker. If the wire position is not optimal then a further hookwire will be inserted using stereotactic guidance.
For those participants who do not need to have surgery for their lesion their participation ends on the day of the stereotactic biopsy.
Participants who need surgery will continue in the study until the specimen XRay and pathology results are available to allow determination of whether the lesion (marker) has been successfully removed. The time between stereotactic core biopsy and any surgery is usually 2-8 weeks depending on whether the lesion is malignant or not on the core biopsy histology.
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Intervention code [1]
285475
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Treatment: Surgery
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Intervention code [2]
287382
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Diagnosis / Prognosis
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Intervention code [3]
287383
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Treatment: Other
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Comparator / control treatment
The performance of six markers will be compared with each other to see which (if any) of them can reliably be used for preoperative localisation of the biopsy site using ultrasound
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Control group
Active
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Outcomes
Primary outcome [1]
287883
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The marker can be well enough seen by the radiologist on the day of preoperative localisation to enable accurate hook wire insertion to be performed using ultrasound control rather than Stereotactic guidance. The radiologist will score the sonographic visibility of each marker using a Likert scale where 0 is not visible and 3 is highly visible
Where the hook wire is inserted using ultrasound, whether or not the marker has been accurately localised will be determined by review of hookwire position relative to marker position on a 2 view mammogram
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Assessment method [1]
287883
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Timepoint [1]
287883
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Assessed at two time points: (1) immediately after the stereotactic core biopsy when the marker has been inserted
(2) on the day of surgery when the participant presents for preoperative localisation of the marker
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Primary outcome [2]
289849
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Incidence and degree of visibility of post biopsy changes (such as hematoma)
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Assessment method [2]
289849
0
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Timepoint [2]
289849
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Assessed using targeted ultrasound (1) immediately following the vacuum assisted core biopsy using targeted ultrasound of the biopsy site and (2) reassessed with targeted ultrasound on the day of the operation
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Secondary outcome [1]
298980
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Whether there is evidence of any movement (migration) of the marker from its original insertion site
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Assessment method [1]
298980
0
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Timepoint [1]
298980
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Assessed on the mammogram performed (1) immediately after the biopsy and (2) on the day of surgery by review of the post hookwire insertion mammogram.
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Eligibility
Key inclusion criteria
Patients with a mammographic abnormality requiring stereotactic vacuum assisted core biopsy
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Minimum age
No limit
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Non-English speaking patients
Pregnant and breast feeding women
Patient unable to tolerate stereotactic biopsy
Lesion not able to be visualised for stereotactic biopsy
The lesion for which stereotactic biopsy was originally planned is found to be visible on a breast ultrasound exam, such that it can be biopsied using ultrasound instead of stereotactic guidance.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
A list of the six markers will be provided to the clinic staff. The order of the markers will be determined by random selection based upon a table of random numbers. They will then be used sequentially starting with the first randomly chosen marker on the list for the first lesion then the next lesion will receive the next marker on the list and so on. When each clip has been used twice a new randomisation will produce a new list and the same process will be repeated. This procedure will be used until sufficient numbers of subjects has been recruited. After clip selection the participant's ID and lesion number will be entered against the marker used on the list so that the next lesion (or participant, if the participant has only one lesion for stereotactic biopsy) will receive the next marker on the list and so on. The radiologist will not be allowed to "choose" which marker is used.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A list of the six markers will be provided to the clinic staff. The order of the markers will be determined by random selection based upon a table of random numbers. They will then be used sequentially starting with the first randomly chosen marker on the list for the first lesion then the next lesion will receive the next marker on the list and so on. When each clip has been used twice a new randomisation will produce a new list and the same process will be repeated. This procedure will be used until sufficient numbers of subjects has been recruited. After clip selection the participant's ID and lesion number will be entered against the marker used on the list so that the next lesion (or participant, if the participant has only one lesion for stereotactic biopsy) will receive the next marker on the list and so on. The radiologist will not be allowed to "choose" which marker is used.
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
Following vacuum assisted core biopsy of one (or more) breast lesions a participant will have one of six different markers inserted into the biopsy site. Each participant may have more than one breast lesion that requires a biopsy in which case the next marker on the list will be used to ensure a different marker is used for each lesion.
The performance of each marker (how visible it is on ultrasound and whether it stays at the biopsy site) will be assessed and compared.
Our final end point is which if any of these markers can be reliably used for preoperative lesion localisation using ultrasound guided hookwire insertion.
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
The ordinal outcome measure will be skewed and so the median and inter-quartile range will be used for description of the markers. For hypothesis testing the Kruskal-Wallis test will be used for univariate comparison of the six markers. Ordinal logistic regression with dummy variables will be used for multivariate analysis of factors associated with marker design and patient characteristics.
Sample size and power analysis
a. The analysis will be based upon a non-parametric Kruskal-Wallis one-way analysis of variance of the primary outcome variable, sonographic visibility.
b. Statistical significance has been set at alpha equals 0.05 and power at 90%.
c. Clinical significance has been set at an effect size of 0.6, so that a difference between any two markers of 60% of one standard deviation of sonographic visibility will be statistically significant.
The power analysis shows that a group sample size of ten subjects is required for each clip investigated
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Recruitment
Recruitment status
Stopped early
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Data analysis
No data analysis planned
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Reason for early stopping/withdrawal
Participant recruitment difficulties
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Date of first participant enrolment
Anticipated
3/07/2013
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Actual
3/07/2017
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Date of last participant enrolment
Anticipated
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Actual
3/07/2017
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Date of last data collection
Anticipated
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Actual
3/07/2017
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Sample size
Target
170
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Accrual to date
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Final
1
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment hospital [1]
1140
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Royal Perth Hospital - Perth
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Funding & Sponsors
Funding source category [1]
287495
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Self funded/Unfunded
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Name [1]
287495
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Address [1]
287495
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Country [1]
287495
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Primary sponsor type
Hospital
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Name
Royal Perth Hospital
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Address
Wellington Street
Perth WA 6001
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Country
Australia
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Secondary sponsor category [1]
284632
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None
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Name [1]
284632
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Address [1]
284632
0
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Country [1]
284632
0
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
287821
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The Royal Perth Hospital Human Research Ethics Committee
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Ethics committee address [1]
287821
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Level 5 Colonial House,
Royal Perth Hospital,
GPO Box X2213 Perth WA 6001
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Ethics committee country [1]
287821
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Australia
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Date submitted for ethics approval [1]
287821
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11/04/2012
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Approval date [1]
287821
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07/08/2012
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Ethics approval number [1]
287821
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2012/049
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Summary
Brief summary
This study is evaluating how well six different types of ultrasound enhanced breast biopsy markers can be visualised using ultrasound on the day of surgery to act as a target for preoperative ultrasound guided lesion localisation with hook wire for surgical removal. Who is it for? You may be eligible to join this study if you have a mammographic abnormality requiring stereotactic vacuum assisted core biopsy. Trial details Following vacuum assisted core biopsy of one (or more) breast lesions, a participant will have one marker randomly (by chance) selected from six different marker types inserted into the biopsy site. Each participant may have more than one breast lesion that requires a biopsy in which case the next marker on the list will be used to ensure a different marker is used for each lesion. The performance of each marker (how visible it is on ultrasound and whether it stays at the biopsy site) will be assessed and compared to determine if any of these markers can be reliably used for preoperative lesion localisation using ultrasound guided hook wire insertion.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
34570
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Dr Donna Taylor
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Address
34570
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Department of Diagnostic and Interventional Radiology
Royal Perth Hospital
Box X2213 GPO
Perth 6847
WA
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Country
34570
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Australia
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Phone
34570
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61 8 92242125
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Fax
34570
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61 8 92243764
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Email
34570
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[email protected]
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Contact person for public queries
Name
17817
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Dr Dr Donna Taylor
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Address
17817
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Department of Diagnostic and Interventional Radiology
Royal Perth Hospital
Box X2213 GPO
Perth 6847
WA
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Country
17817
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Australia
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Phone
17817
0
61 8 92242125
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Fax
17817
0
61 8 92243764
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Email
17817
0
[email protected]
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Contact person for scientific queries
Name
8745
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Dr Dr Donna Taylor
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Address
8745
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Department of Diagnostic and Interventional Radiology
Royal Perth Hospital
Box X2213 GPO
Perth 6847
WA
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Country
8745
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Australia
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Phone
8745
0
61 8 92242125
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Fax
8745
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61 8 92243764
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Email
8745
0
[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
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No/undecided IPD sharing reason/comment
discussion with investigators ongoing
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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.
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