Skip to content

BreastScreen Victoria pilot trial of the feasibility and outcomes of tomosynthesis (3D-mammography) screening at Eastern Health

BreastScreen Victoria pilot trial of the feasibility and outcomes of tomosynthesis (3D-mammography) screening at Eastern Health

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617000947303
Enrollment
5018
Registered
2017-07-03
Start date
2017-08-18
Completion date
2018-11-08
Last updated
2020-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

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.

Sponsors

University of Sydney
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
40 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Women aged 40 years and older attending a BreastScreen service (Maroondah BreastScreen ) for mammography breast screening

Exclusion criteria

Women not eligible to participate in BreastScreen, and those younger than 40 years; and women who are unable to provide consent

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 20, 2026