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Virtual clinical trial to compare cancer detection using combinations of 2D mammography, digital breast tomosynthesis and synthetic 2D imaging

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Abstract

Objectives

This study was designed to compare the detection of subtle lesions (calcification clusters or masses) when using the combination of digital breast tomosynthesis (DBT) and synthetic mammography (SM) with digital mammography (DM) alone or combined with DBT.

Methods

A set of 166 cases without cancer was acquired on a DBT mammography system. Realistic subtle calcification clusters and masses in the DM images and DBT planes were digitally inserted into 104 of the acquired cases. Three study arms were created: DM alone, DM with DBT and SM with DBT. Five mammographic readers located the centre of any lesion within the images that should be recalled for further investigation and graded their suspiciousness. A JAFROC figure of merit (FoM) and lesion detection fraction (LDF) were calculated for each study arm. The visibility of the lesions in the DBT images was compared with SM and DM images.

Results

For calcification clusters, there were no significant differences (p > 0.075) in FoM or LDF. For masses, the FoM and LDF were significantly improved in the arms using DBT compared to DM alone (p < 0.001). On average, both calcification clusters and masses were more visible on DBT than on DM and SM images.

Conclusions

This study demonstrated that masses were detected better with DBT than with DM alone and there was no significant difference (p = 0.075) in LDF between DM&DBT and SM&DBT for calcifications clusters. Our results support previous studies that it may be acceptable to not acquire digital mammography alongside tomosynthesis for subtle calcification clusters and ill-defined masses.

Key Points

The detection of masses was significantly better using DBT than with digital mammography alone.

The detection of calcification clusters was not significantly different between digital mammography and synthetic 2D images combined with tomosynthesis.

Our results support previous studies that it may be acceptable to not acquire digital mammography alongside tomosynthesis for subtle calcification clusters and ill-defined masses for the imaging technology used.

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Abbreviations

DF:

Degrees of freedom

DM:

Digital mammography

FoM:

Figure of merit

FRF:

False recall fraction

JAFROC:

Jackknife alternative free-response receiver operating characteristics

LDF:

Lesion detection fraction

MGD:

Mean glandular dose

SM:

Synthetic 2D images

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Acknowledgements

We thank UZ Leuven for the use of the images. We thank the observers for reading the images in this study. We thank Volpara Inc. for the use of their software. Ethical approval was obtained for this study as part of the OPTIMAM project as well as local ethical committee approval for the retrospective collection of the cases at the test site.

Funding

This study has received funding from the Cancer Research UK: OPTIMAM2 project (grant number: C30682/A17321).

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Alistair Mackenzie.

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Guarantor

The scientific guarantor of this publication is Prof. Kenneth C. Young (ken.young@nhs.net).

Conflict of interest

The authors of this manuscript declare relationships with the following companies:

Chantal Van Ongeval: research and travel agreements with Siemens Healthineers; research agreement with GE Healthcare.

Lesley Cockmartin’s lab has research agreements with Siemens Healthineers and GE Healthcare.

Matthew Wallis: This research was supported by the NIHR Cambridge Biomedical Research Centre (BRC-1215-20014). The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care.

Statistics and biometry

Two of the authors (LMW, AM) have significant statistical expertise for this type of study.

Informed consent

Written informed consent was waived by the Institutional Review Board.

Ethical approval

Institutional Review Board approval was obtained.

Study subjects or cohorts overlap

Five cases were used in a previous publication (https://www.spiedigitallibrary.org/conference-proceedings-of-spie/10952/109520U/An-observer-study-to-assess-the-detection-of-calcification-clusters/10.1117/12.2506895.full). In those cases, either the images used were a different view or a different lesion was inserted.

Methodology

• not applicable (prospective/retrospective)

• experimental

• multicentre study

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Mackenzie, A., Thomson, E.L., Mitchell, M. et al. Virtual clinical trial to compare cancer detection using combinations of 2D mammography, digital breast tomosynthesis and synthetic 2D imaging. Eur Radiol 32, 806–814 (2022). https://doi.org/10.1007/s00330-021-08197-x

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  • DOI: https://doi.org/10.1007/s00330-021-08197-x

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