TY - JOUR
T1 - Contrast-enhanced mammography versus conventional imaging in women recalled from breast cancer screening (RACER trial)
T2 - a multicentre, open-label, randomised controlled clinical trial
AU - Neeter, Lidewij M.F.H.
AU - Nelemans, Patricia J.
AU - Raat, H. P.J.
AU - Frotscher, Caroline
AU - Duvivier, Katya M.
AU - Essers, Brigitte A.B.
AU - Smidt, Marjolein L.
AU - Wildberger, Joachim E.
AU - Lobbes, Marc B.I.
N1 - Funding Information:
M.L. received research funding from GE Healthcare, Hologic Inc., and Sirius Medical B.V. M.L. received honorary fees for presentations and participation of medical advisory boards from GE Healthcare, Hologic Inc., Sirius Medical B.V., Bayer, Guerbet, and Tromp Medical B.V. J.W. received institutional grants from Adora/Oldelft, Anaconda, Bard, Bayer, Bentley, Boston, Brainlab, GE Healthcare, Inari Medical, Johnson & Johnson, Merit Medical, Nico-Lab, Philips, Sectra, Siemens, and Stryker. J.W. received speaker\u2019s fees from Bayer and Siemens. L.N., K.D., P.N., F.R., C.F., M.S., and B.E. had no conflicts of interest to report.
Funding Information:
ZonMw (grant number 843001801) and GE Healthcare.
Funding Information:
This trial received funding from the Netherlands Organisation for Health Research and Development (ZonMw Efficiency Studies Grant Number 843001801) and GE Healthcare. ZonMw was involved in the trial design. GE Healthcare was not involved in data collection, analyses, or manuscript writing. No authors were precluded from accessing data in the study. All authors accept responsibility to submit for publication.
Funding Information:
We wish to acknowledge the Netherlands Organisation for Health Research and Development, better known as ZonMw (ZonMw Efficiency Studies Grant Number 843001801) and GE Healthcare for funding this study. During the preparation of this work the authors used Grammarly in order to check for residual English language and grammar errors. After using this tool/service, the authors reviewed and edited the content as needed and take full responsibility for the content of the publication.
Publisher Copyright:
© 2024 The Author(s)
PY - 2024/9/1
Y1 - 2024/9/1
N2 - Background: Women recalled from breast cancer screening receive post-screening work-up in the hospital with conventional breast imaging. The RACER trial aimed to study whether contrast-enhanced mammography (CEM) as primary imaging instead of conventional imaging resulted in more accurate and efficient diagnostic work-up in recalled women. Methods: In this randomised, controlled trial (registered under NL6413/NTR6589) participants were allocated using deterministic minimisation to CEM or conventional imaging as a primary work-up tool in two general and two academic hospitals. Predefined patients’ factors were reason for recall, BI-RADS score, and study centre. Primary outcomes were sensitivity and specificity. Secondary outcomes were the proportion of women needing supplemental examinations, and number of days until diagnosis. Findings: Between April, 2018, and September, 2021, 529 patients recalled from the Dutch screening program were randomised, 265 to conventional imaging and 264 to CEM. Three patients in the control arm had to be excluded from analysis due to a protocol breach. After the entire work-up, sensitivity was 98.0% (95% CI; 92.2–99.7%) in the intervention arm and 97.7% (91.8–99.6%) in the control arm (p = 1.0), and specificity was 75.6% (72.5–76.6%) and 75.4% (72.5–76.4%, p = 1.0), respectively. Based on only primary full-field digital mammography/digital breast tomosynthesis or CEM, final diagnosis was reached in 27.7% (73/264) in the intervention arm and 1.1% (3/262) in the control arm. The frequency of supplemental imaging was significantly higher in the control arm (p < 0.0001). Median time needed to reach final diagnosis was comparable: 1 day (control arm: IQR 0–4; intervention arm: IQR 0–3). Thirteen malignant occult lesions were detected using CEM, versus three using conventional imaging. No serious adverse events occurred. Interpretation: Diagnostic accuracy of CEM in the work-up of recalled women is comparable with conventional imaging. However, work-up with CEM as primary imaging is a more efficient pathway. Funding: ZonMw (grant number 843001801) and GE Healthcare.
AB - Background: Women recalled from breast cancer screening receive post-screening work-up in the hospital with conventional breast imaging. The RACER trial aimed to study whether contrast-enhanced mammography (CEM) as primary imaging instead of conventional imaging resulted in more accurate and efficient diagnostic work-up in recalled women. Methods: In this randomised, controlled trial (registered under NL6413/NTR6589) participants were allocated using deterministic minimisation to CEM or conventional imaging as a primary work-up tool in two general and two academic hospitals. Predefined patients’ factors were reason for recall, BI-RADS score, and study centre. Primary outcomes were sensitivity and specificity. Secondary outcomes were the proportion of women needing supplemental examinations, and number of days until diagnosis. Findings: Between April, 2018, and September, 2021, 529 patients recalled from the Dutch screening program were randomised, 265 to conventional imaging and 264 to CEM. Three patients in the control arm had to be excluded from analysis due to a protocol breach. After the entire work-up, sensitivity was 98.0% (95% CI; 92.2–99.7%) in the intervention arm and 97.7% (91.8–99.6%) in the control arm (p = 1.0), and specificity was 75.6% (72.5–76.6%) and 75.4% (72.5–76.4%, p = 1.0), respectively. Based on only primary full-field digital mammography/digital breast tomosynthesis or CEM, final diagnosis was reached in 27.7% (73/264) in the intervention arm and 1.1% (3/262) in the control arm. The frequency of supplemental imaging was significantly higher in the control arm (p < 0.0001). Median time needed to reach final diagnosis was comparable: 1 day (control arm: IQR 0–4; intervention arm: IQR 0–3). Thirteen malignant occult lesions were detected using CEM, versus three using conventional imaging. No serious adverse events occurred. Interpretation: Diagnostic accuracy of CEM in the work-up of recalled women is comparable with conventional imaging. However, work-up with CEM as primary imaging is a more efficient pathway. Funding: ZonMw (grant number 843001801) and GE Healthcare.
KW - Breast neoplasm
KW - Mammography
KW - Screening
U2 - 10.1016/j.lanepe.2024.100987
DO - 10.1016/j.lanepe.2024.100987
M3 - Article
SN - 2666-7762
VL - 44
JO - The Lancet Regional Health – Europe
JF - The Lancet Regional Health – Europe
M1 - 100987
ER -