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Assessment of task-based performance from five clinical DBT systems using an anthropomorphic breast phantom
Lynda C Ikejimba1, Jesse Salad1, Christian G Graff1
1US Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD, 20993, USA.
Medical Physics
|October 31, 2020
Summary
This study introduces a novel method using an inkjet-printed phantom to evaluate digital breast tomosynthesis (DBT) systems. DBT demonstrated superior detection of masses and microcalcifications compared to other mammography techniques.
Area of Science:
- Medical Imaging
- Radiology
- Biomedical Engineering
Background:
- Digital breast tomosynthesis (DBT) is a crucial breast cancer screening tool, often used with full-field digital mammography (FFDM) or synthetic mammography (SM).
- Existing FDA-approved DBT systems vary significantly in design and imaging protocols, necessitating a standardized quantitative assessment method.
- The technical differences among DBT systems hinder direct comparison and performance evaluation.
Purpose of the Study:
- To introduce and validate a novel quantitative methodology for assessing the performance of commercial digital breast tomosynthesis (DBT) systems.
- To compare the efficacy of DBT against FFDM and synthetic mammography (SM) using a standardized phantom and reader study.
- To establish a benchmark for evaluating diverse DBT system designs and imaging protocols.
Main Methods:
- Fabrication of an anthropomorphic breast phantom using inkjet printing with realistic simulated masses (spiculated, KI-doped ink) and microcalcifications (calcium hydroxyapatite).
- Acquisition of phantom images using five commercial DBT systems, FFDM, and SM modalities under automatic exposure control.
- Conducting a four-alternative forced choice (4AFC) reader study to assess performance in detecting simulated masses and microcalcifications, followed by statistical analysis of proportion correct (PC).
Main Results:
- Digital breast tomosynthesis (DBT) exhibited the highest overall detection rates for simulated masses, with statistically significant improvements over SM for most systems.
- A positive correlation was observed between increased reader performance (PC) and greater gantry span across DBT systems.
- DBT and FFDM showed superior performance in detecting microcalcifications compared to SM, with statistically significant differences across all manufacturers.
Conclusions:
- The developed methodology, utilizing an inkjet-printed anthropomorphic phantom, offers a novel and effective approach for quantitatively evaluating clinical DBT imaging systems.
- This study is the first to employ such a realistic phantom for assessing the performance of multiple commercial DBT systems.
- The findings highlight DBT's advantages in detecting both masses and microcalcifications, providing valuable insights for system selection and development.

