Contrast-enhanced mammography versus conventional imaging in women recalled from breast cancer screening (RACER trial): a multicentre, open-label, randomised controlled clinical trial.

Autor:	Neeter LMFH; Maastricht University Medical Center, Department of Radiology and Nuclear Medicine, P.O. Box 5800, 6202AZ, Maastricht, the Netherlands.; GROW School for Oncology and Reproduction, Maastricht University, P.O. Box 616, 6200MD, Maastricht, the Netherlands., Nelemans PJ; Maastricht University, Department of Epidemiology, P.O. Box 616, 6200MD, Maastricht, the Netherlands., Raat HPJ; Laurentius Hospital, Department of Radiology, P.O. Box 920, 6040 AX, Roermond, the Netherlands., Frotscher C; Zuyderland Medical Center, Department of Medical Imaging, P.O. Box 5500, 6130 MB, Sittard-Geleen, the Netherlands., Duvivier KM; Amsterdam University Medical Center, Department of Radiology, P.O. Box 7057, 1007MB, Amsterdam, the Netherlands., Essers BAB; Maastricht University Medical Center, Department of Clinical Epidemiology and Medical Technology Assessment, P.O. Box 5800, 6202AZ, Maastricht, the Netherlands.; CAPHRI Care and Public Health Research Institute, Maastricht University, P.O. Box 616, 6200MD, Maastricht, the Netherlands., Smidt ML; GROW School for Oncology and Reproduction, Maastricht University, P.O. Box 616, 6200MD, Maastricht, the Netherlands.; Maastricht University Medical Center, Department of Surgery, P.O. Box 5800, 6202AZ, Maastricht, the Netherlands., Wildberger JE; Maastricht University Medical Center, Department of Radiology and Nuclear Medicine, P.O. Box 5800, 6202AZ, Maastricht, the Netherlands., Lobbes MBI; Maastricht University Medical Center, Department of Radiology and Nuclear Medicine, P.O. Box 5800, 6202AZ, Maastricht, the Netherlands.; GROW School for Oncology and Reproduction, Maastricht University, P.O. Box 616, 6200MD, Maastricht, the Netherlands.; Zuyderland Medical Center, Department of Medical Imaging, P.O. Box 5500, 6130 MB, Sittard-Geleen, the Netherlands.
Jazyk:	angličtina
Zdroj:	The Lancet regional health. Europe [Lancet Reg Health Eur] 2024 Jul 03; Vol. 44, pp. 100987. Date of Electronic Publication: 2024 Jul 03 (Print Publication: 2024).
DOI:	10.1016/j.lanepe.2024.100987
Abstrakt:	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. Competing Interests: 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's fees from Bayer and Siemens. L.N., K.D., P.N., H.R., C.F., M.S., and B.E. had no conflicts of interest to report. (© 2024 The Author(s).)
Databáze:	MEDLINE
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