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BreastScreen trial of hybrid tomosynthesis versus mammography screening

A co-designed prospective trial of the effectiveness of hybrid digital breast tomosynthesis/digital mammography compared to digital mammography in women presenting for routine screening at Maroondah BreastScreen

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12623001144606
Enrollment
75
Registered
2023-11-06
Start date
2024-03-18
Completion date
2026-06-01
Last updated
2024-05-06

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 prospective comparative trial embedded in population-based screening, at Maroondah BreastScreen, Eastern Health, will examine screening outcomes of hybrid digital breast tomosynthesis/mammography compared to digital mammography screening (standard of care) in women presenting 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 Current standard of care for breast screening is bilateral two-view (MLO and CC) digital mammography screening which represents 2-dimensional (2D) imaging. Intervention in this study is digital breast tomosynthesis (DBT, quasi-3D-mammography) acquisition for the MLO view only (2D-mammography images will be reconstructed from the DBT to provide synthetic 2D). Standard digital mammography will be acquired for the CC-view. This is referred to as ‘hybrid tomosynthesis/mammography’ screening or the ‘intervention screen’ in this trial. Other aspects of screening and assessment, and any required follow-up, will be based on standard BreastScreen protocols and quality assurance processes. The trial will assess initial detection measures (cancer detection, and recall for further testing) as well as outcomes at follow-up (to determine interval cancer rates).

Interventions

Current standard of care for breast screening is bilateral two-view (MLO and CC) digital mammography screening which represents 2-dimensional (2D) imaging. Intervention: 2D-mammography will be replaced with digital breast tomosynthesis (DBT, quasi-3D-mammography) acquisition for the MLO view only (2D-mammography images will be reconstructed from the DBT to provide synthetic 2D). Standard digital mammography will be acquired for the CC-view. This is referred to as ‘hybrid tomosynthesis/mammogra

Current standard of care for breast screening is bilateral two-view (MLO and CC) digital mammography screening which represents 2-dimensional (2D) imaging. Intervention: 2D-mammography will be replaced with digital breast tomosynthesis (DBT, quasi-3D-mammography) acquisition for the MLO view only (2D-mammography images will be reconstructed from the DBT to provide synthetic 2D). Standard digital mammography will be acquired for the CC-view. This is referred to as ‘hybrid tomosynthesis/mammography’ screening or the ‘intervention screen’ in this trial. The process for the hybrid (intervention) screen is similar to the routine breast screen in that both involve transient compression of the breasts, x-ray acquisition by a radiographer, and take approximately 15 minutes.

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
No

Inclusion criteria

Women who are eligible to participate in the BreastScreen program and attending for a mammographic screen at Maroondah BreastScreen: East Ringwood screening site (intervention site) and Mont Albert screening site (standard screening site)

Exclusion criteria

- Women aged less than 40 years, or who are (or may be) pregnant or breastfeeding (not eligible for breast screening) -Women deemed unable to provide informed consent (will have standard mammography screen). -Women in whom a ‘pushback’ image cannot be obtained due to their breast implant will be excluded from the hybrid (intervention) screen due to technical issues and will have standard 2D-mammography.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 9, 2026