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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?
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
Secondary ID [1] 281017 0
Nil
Universal Trial Number (UTN)
U1111-1144-7425
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast cancer 287152 0
Preoperative image guided localisation of impalpable breast cancers to guide surgery 287301 0
Condition category
Condition code
Cancer 287471 287471 0 0
Breast

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 285475 0
Treatment: Surgery
Intervention code [2] 287382 0
Diagnosis / Prognosis
Intervention code [3] 287383 0
Treatment: Other
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
Control group
Active

Outcomes
Primary outcome [1] 287883 0
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
Timepoint [1] 287883 0
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
Primary outcome [2] 289849 0
Incidence and degree of visibility of post biopsy changes (such as hematoma)
Timepoint [2] 289849 0
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
Secondary outcome [1] 298980 0
Whether there is evidence of any movement (migration) of the marker from its original insertion site
Timepoint [1] 298980 0
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.

Eligibility
Key inclusion criteria
Patients with a mammographic abnormality requiring stereotactic vacuum assisted core biopsy
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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.
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.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
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.
Phase
Not Applicable
Type of endpoint/s
Efficacy
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

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
3/07/2013
Actual
3/07/2017
Date of last participant enrolment
Anticipated
Actual
3/07/2017
Date of last data collection
Anticipated
Actual
3/07/2017
Sample size
Target
170
Accrual to date
Final
1
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 1140 0
Royal Perth Hospital - Perth

Funding & Sponsors
Funding source category [1] 287495 0
Self funded/Unfunded
Name [1] 287495 0
Country [1] 287495 0
Primary sponsor type
Hospital
Name
Royal Perth Hospital
Address
Wellington Street
Perth WA 6001
Country
Australia
Secondary sponsor category [1] 284632 0
None
Name [1] 284632 0
Address [1] 284632 0
Country [1] 284632 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287821 0
The Royal Perth Hospital Human Research Ethics Committee
Ethics committee address [1] 287821 0
Ethics committee country [1] 287821 0
Australia
Date submitted for ethics approval [1] 287821 0
11/04/2012
Approval date [1] 287821 0
07/08/2012
Ethics approval number [1] 287821 0
2012/049

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

Contacts
Principal investigator
Name 34570 0
Dr Donna Taylor
Address 34570 0
Department of Diagnostic and Interventional Radiology
Royal Perth Hospital
Box X2213 GPO
Perth 6847
WA
Country 34570 0
Australia
Phone 34570 0
61 8 92242125
Fax 34570 0
61 8 92243764
Email 34570 0
donna.taylor@health.wa.gov.au
Contact person for public queries
Name 17817 0
Dr Donna Taylor
Address 17817 0
Department of Diagnostic and Interventional Radiology
Royal Perth Hospital
Box X2213 GPO
Perth 6847
WA
Country 17817 0
Australia
Phone 17817 0
61 8 92242125
Fax 17817 0
61 8 92243764
Email 17817 0
donna.taylor@health.wa.gov.au
Contact person for scientific queries
Name 8745 0
Dr Donna Taylor
Address 8745 0
Department of Diagnostic and Interventional Radiology
Royal Perth Hospital
Box X2213 GPO
Perth 6847
WA
Country 8745 0
Australia
Phone 8745 0
61 8 92242125
Fax 8745 0
61 8 92243764
Email 8745 0
donna.taylor@health.wa.gov.au

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


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.