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Trial registered on ANZCTR


Registration number
ACTRN12617000947303
Ethics application status
Approved
Date submitted
27/06/2017
Date registered
3/07/2017
Date last updated
4/02/2020
Date data sharing statement initially provided
4/02/2020
Date results information initially provided
4/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
BreastScreen Victoria pilot trial of the feasibility and outcomes of tomosynthesis (3D-mammography) screening at Eastern Health
Scientific title
BreastScreen Victoria pilot trial of the feasibility and outcomes of tomosynthesis (3D-mammography) screening at Eastern Health
Secondary ID [1] 292288 0
Nil known
Universal Trial Number (UTN)
U1111-1198-3670
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 303808 0
Condition category
Condition code
Cancer 303174 303174 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Current standard of care in breast screening is bilateral 2-view (MLO and CC) digital mammography (2D-mammography). In this trial, participants will have an opportunity to have digital breast tomosynthesis ((3D- mammography) acquisition from which 2D-mammography images are also reconstructed (synthetic 2D), in place of standard 2D-mammography. Tomosynthesis screening will consist of bilateral 2-view (MLO and CC) 3D-mammography acquisitions, performed by a radiographer, The procedure is similar to that for 2D-mammography (except that 3D-acquisitions will replace 2D-acquisitions) and is usually completed in 15-20 minutes.
All aspects of screening, reading and assessment, and any required monitoring or follow-up, will be based on standard screening protocols and quality assurance processes for BreastScreen Victoria (Australia). Standard BreastScreen program double-reading practice (two independent readings to interpret each screen) will be followed; disagreement between readers will use a third reader as currently practiced at BreastScreen.
Intervention code [1] 298460 0
Early detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 302554 0
- Cancer detection: cancer detection rate (per 1,000 screens) will be estimated based on the number of breast cancers detected at screening and verified at histology
Timepoint [1] 302554 0
Within 2-8 weeks of attending for screening
Primary outcome [2] 302555 0
Feasibility of tomosynthesis (3D-mammography) screening based on demonstrating implementation, and feedback from screening service
Timepoint [2] 302555 0
Throughout recruitment of participants
Primary outcome [3] 302606 0
- Recall data: the number of recalls (and false recalls), calculated as a proportion of the total number of screened women; based on recall from screening to assessment and assessment findings
Timepoint [3] 302606 0
Within 2-8 weeks of attending for screening
Secondary outcome [1] 336368 0
Participation rates, based on participation data reports from BreastScreen
Timepoint [1] 336368 0
Every 12-14 weeks
Secondary outcome [2] 336369 0
Histological characteristics of breast cancers detected at screening, based on histopathology reports
Timepoint [2] 336369 0
6 weeks to 6 months post-screen date
Secondary outcome [3] 336370 0
Assessment procedures: descriptive data on tests performed at assessment, based on routine BreastScreen data collection for assessment
Timepoint [3] 336370 0
Within 2-8 weeks of attending for screening
Secondary outcome [4] 336371 0
Radiation metrics (mean glandular dose (mGy) per view) - collected from DICOM exposure data
Timepoint [4] 336371 0
At reaching 2,000 participants, estimated at 6 months post-trial commencement

Eligibility
Key inclusion criteria
Women aged 40 years and older attending a BreastScreen service (Maroondah BreastScreen ) for mammography breast screening
Minimum age
40 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Women not eligible to participate in BreastScreen, and those younger than 40 years; and women who are unable to provide consent

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Women routinely invited to have their screening mammogram through standard BreastScreen Victoria process at Maroondah BreastScreen will receive an information flyer advising them of this study. Women will be advised that they will receive tomosynthesis (synthetic 2D/3D-mammography) or standard 2D-mammography, and will be given the option to opt-out of the study (and will receive standard 2D-mammography if they opt out). There are two mammography units that operate at the Maroondah service, both units can perform 2D screens however only one unit can perform 3D acquisitions. If the woman consents to participating, she will then receive either 2D or 3D acquisition, this being by chance of which mammography unit is available when they are taken into the screening procedure.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Sample size (5,000 women) was chosen because it would enable feasibility of implementing the study and allows an estimation of screen-detection measures especially for cancer detection rate given that breast cancer is not a frequent outcome. Using data on screening outcomes from BreastScreen Victoria, and the range of incremental cancer detection attributed to tomosynthesis screening in published studies, we estimate that tomosynthesis would detect approximately 9.0 cancer per 1,000 screens; hence an estimate based on a sample size of 5,000 screens would have a standard error of approximately 1.3 per 1,000 screens.

Primary analyses will examine the following:
-Cancer detection measures: the number of detected cancers will be reported, and the cancer detection rate (per 1,000 screens) will be estimated with 95% CI.
-Recall data: the number of recalls will be calculated as a proportion of the total number of screened women; the number of recalled women shown not to have cancer at assessment (false recalls) will be reported as a proportion of the total screened (minus those shown to have cancer) to estimate the false-positive recall percentage with 95% CI.

Secondary outcome measures will also be reported:
-Participation rates for the trial
-Descriptive data on the characteristics of breast cancers (size, histology, grade, node status, and biomarkers) detected in the study participants
-Data on assessment procedures and outcomes
-Quantitative measures of average radiation metrics: estimation of the breast mean glandular dose (mGy)

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 296830 0
Charities/Societies/Foundations
Name [1] 296830 0
National Breast Cancer Foundation
Address [1] 296830 0
National Breast Cancer Foundation
Level 9, 10 Barrack St, Sydney 2000
GPO Box 4126 Sydney NSW 2001
Country [1] 296830 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Sydney School of Public Health, Sydney Medical School
Edward Ford Building (A27)
The University of Sydney, NSW, 2006
Country
Australia
Secondary sponsor category [1] 295821 0
Government body
Name [1] 295821 0
BreastScreen Victoria
Address [1] 295821 0
Level 1/31 Pelham Street
Carlton South Vic 3053
Country [1] 295821 0
Australia
Secondary sponsor category [2] 295831 0
Other
Name [2] 295831 0
Maroondah BreastScreen
Address [2] 295831 0
Maroondah BreastScreen, Eastern Health
24 Grey Street, East Ringwood, Vic 3135
Country [2] 295831 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298063 0
Eastern Health Human Research Ethics Committee
Ethics committee address [1] 298063 0
Eastern Health - Office of Research and Ethics
Eastern Health, East Ringwood, Victoria 3135
Ethics committee country [1] 298063 0
Australia
Date submitted for ethics approval [1] 298063 0
01/05/2017
Approval date [1] 298063 0
23/05/2017
Ethics approval number [1] 298063 0
LR36/2017

Summary
Brief summary
This pilot study will assess the feasibility and the outcomes of using digital breast tomosynthesis (3D-mammography) for routine breast screening.

Who is it for?
You may be eligible to join this study if you are a woman aged 40 years or above and are attending a BreastScreen service at Maroondah BreastScreen.

Study details
Women who attend for routine breast screening will have an opportunity to have tomosynthesis screening (3D-mammography acquisition with synthetic 2D-mammography) in place of standard 2D-mammography, those declining to participate will have standard 2D-mammography. 3D mammography screening involves having x-rays of both breasts (taken as two views of each breast, with the breast transiently compressed similarly to conventional 2D mammograms). There are two mammography units that operate at the Maroondah service, both units can perform 2D screens however only one unit can perform 3D acquisitions. If the woman consents to participating, she will then receive either 2D or 3D acquisition, this being by chance of which mammography unit is available when they are taken into the screening procedure.

All other aspects of screening, reading and assessment, and any required follow-up, will be based on standard BreastScreen protocols and quality assurance processes.

Screening detection measures and feasibility of using 3D mammography will be assessed. It is hoped that this pilot feasibility study will inform planning of future larger studies using 3D mammography or further evaluation in BreastScreen Australia.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 75870 0
Prof Nehmat Houssami
Address 75870 0
A27 - Edward Ford Building
Sydney School of Public Health, Sydney Medical School
The University of Sydney NSW 2006
Country 75870 0
Australia
Phone 75870 0
+61 419 273510
Fax 75870 0
Email 75870 0
nehmat.houssami@sydney.edu.au
Contact person for public queries
Name 75871 0
Ms Michelle Clemson
Address 75871 0
Maroondah BreastScreen, Eastern Health
24 Grey Street, East Ringwood, Victoria 3135
Country 75871 0
Australia
Phone 75871 0
+61 03 9870 0988
Fax 75871 0
Email 75871 0
mclemson@breastscreen.org.au
Contact person for scientific queries
Name 75872 0
Prof Nehmat Houssami
Address 75872 0
A27 - Edward Ford Building
Sydney School of Public Health, Sydney Medical School
The University of Sydney NSW 2006
Country 75872 0
Australia
Phone 75872 0
+61 419 273510
Fax 75872 0
Email 75872 0
nehmat.houssami@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Summary results
Have study results been published in a peer-reviewed journal?
Yes
Journal publication details
Publication date and citation/details [1] 6724 0
Pilot trial of digital breast tomosynthesis (3D mammography) for population-based screening in BreastScreen Victoria. Houssami et al MJA 2019 (doi: 10.5694/mja2.50320)
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary
The pilot trial showed that routine breast screening using tomosynthesis (3D mammograms) in Maroondah BreastScreen had a cancer detection rate of 9.8 cancers per 1000 screens (amongst the women having screening by the standard mammogram detection was 6.6 cancers per 1000 screens), but the recall rate was higher for tomosynthesis than standard mammograms (4.2% v 3.0%).